Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse... | NCT01641809 | Trialant
NCT01641809
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Jan 30, 2020Actual
Enrollment
244Actual
Phase
Phase 2
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Interventions
GSK1265744 10 mg
GSK1265744 30 mg
GSK1265744 60 mg
Efavirenz 600 mg
Rilpivirine 25 mg
Placebo
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01641809
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
116482
Secondary IDs
Not provided
Brief Title
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
Official Title
A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppression When Oral GSK1265744 is Combined With Oral Rilpivirine in HIV-1 Infected, Antiretroviral Therapy Naive Adult Subjects
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Jan 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 6, 2012Actual
Primary Completion Date
Oct 10, 2013Actual
Completion Date
Jan 15, 2019Actual
First Submitted Date
Jun 28, 2012
First Submission Date that Met QC Criteria
Jul 12, 2012
First Posted Date
Jul 17, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 21, 2020
Results First Submitted that Met QC Criteria
Jan 21, 2020
Results First Posted Date
Jan 30, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 13, 2014
Certification/Extension First Submitted that Passed QC Review
Mar 13, 2014
Certification/Extension First Posted Date
Apr 11, 2014Estimated
Last Update Submitted Date
Jan 21, 2020
Last Update Posted Date
Jan 30, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects.
This study consists of two parts:
Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study.
Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96.
After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.
Detailed Description
Not provided
Conditions Module
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Keywords
HIV -1
GSK1265744
maintenance phase
dose selection
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
244Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1 GSK1265744 10 mg
Experimental
In the Induction Phase subjects will receive oral tablets of GSK1265744 10 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 10 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.
Drug: GSK1265744 10 mg
Drug: Rilpivirine 25 mg
Drug: Placebo
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Arm 2 GSK1265744 30 mg
Experimental
In the Induction Phase subjects will receive oral tablets of GSK1265744 30 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 30 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.
Drug: GSK1265744 30 mg
Drug: Rilpivirine 25 mg
Drug: Placebo
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Arm 3 GSK1265744 60 mg
Experimental
In the Induction Phase subjects will receive oral tablets of GSK1265744 60 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 60 mg + Rilpivirine 25 mg once daily from Week 24 to Week 96.
Drug: GSK1265744 60 mg
Drug: Rilpivirine 25 mg
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK1265744 10 mg
Drug
GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
Week 48
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
HIV-1 infected male or female subjects >= 18 years of age
Screening plasma HIV-1 RNA >=1000 c/mL
CD4+ cell count >=200 cells/millimeter (mm)^3
ART-naive defined as having =<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study
Exclusion Criteria:
Any evidence at screening of an active Centers for Disease and Prevention Control (CDC) Category C disease
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
History of ongoing or clinically relevant hepatitis within the previous 6 months, and subjects with moderate to severe hepatic impairment will be excluded
Women who are breastfeeding
Subject, who in the investigator's judgment, poses a significant suicide risk
Any clinically significant finding on screening or baseline electrocardiograph (ECG)
The presence of any specific laboratory abnormalities at Screening
History of cardiac disease
Clinically relevant pancreatitis
Subjects who are unlikely to complete the dosing schedule due to a pre-existing physical or mental condition
Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product
Any evidence of primary resistance based upon the presence of a major resistance associated mutation in the Screening HIV genotype, or any historical genotype
Treatment with any protocol-specified excluded medication
Mills A, Richmond GJ, Newman C, Osiyemi O, Cade J, Brinson C, De Vente J, Margolis DA, Sutton KC, Wilches V, Hatch S, Roberts J, McCoig C, Garris C, Vandermeulen K, Spreen WR. Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. AIDS. 2022 Feb 1;36(2):195-203. doi: 10.1097/QAD.0000000000003085.
A total of 324 participants were screened, of which 80 failed screening and 244 participants were randomized to one of the four treatment arms in a ratio of 1:1:1:1. Of the 244 randomized participants, only 243 received atleast one dose of study treatment and comprised the Intent-to-Treat-Exposed (ITT-E) Population.
Recruitment Details
This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Periods
Title
Milestones
Reasons Not Completed
Induction Phase (Day 1 to Week 24)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Arm 4 Efavirenz 600 mg
Active Comparator
In the Induction Phase and Maintenance Phase subjects will receive oral tablets of Efavirenz 600 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine).
Drug: Efavirenz 600 mg
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Arm 1 GSK1265744 10 mg
GSK1265744 30 mg
Drug
GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Arm 2 GSK1265744 30 mg
GSK1265744 60 mg
Drug
GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Arm 3 GSK1265744 60 mg
Efavirenz 600 mg
Drug
Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
Arm 4 Efavirenz 600 mg
Rilpivirine 25 mg
Drug
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Arm 1 GSK1265744 10 mg
Arm 2 GSK1265744 30 mg
Arm 3 GSK1265744 60 mg
Placebo
Drug
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
Arm 1 GSK1265744 10 mg
Arm 2 GSK1265744 30 mg
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Drug
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
Up to Week 324
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Up to Week 324
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Up to Week 324
Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Week 16 and Week 24
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Week 24 to Week 96
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Week 24 to Week 96
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Week 24 to Week 96
Number of Participants With AEs and SAEs Over Time
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Up to Week 324
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Up to Week 324
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Up to Week 324
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.
Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.
Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Up to Week 324
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.
Up to Week 324
Number of Participants With AEs and SAEs-Induction Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.
Up to Week 24
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Up to Week 24
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Up to Week 24
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Up to Week 24
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Week 24 to Week 96
Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data
pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2
AUC(0 to Tau) for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Cmax for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Ctau for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Phoenix
Arizona
85015
United States
GSK Investigational Site
Little Rock
Arkansas
72207
United States
GSK Investigational Site
Bakersfield
California
93301
United States
GSK Investigational Site
Beverly Hills
California
90211
United States
GSK Investigational Site
Long Beach
California
90813
United States
GSK Investigational Site
Los Angeles
California
90069
United States
GSK Investigational Site
San Francisco
California
94115
United States
GSK Investigational Site
Denver
Colorado
80209
United States
GSK Investigational Site
Washington D.C.
District of Columbia
20007
United States
GSK Investigational Site
Washington D.C.
District of Columbia
20037
United States
GSK Investigational Site
Fort Lauderdale
Florida
33308
United States
GSK Investigational Site
Fort Lauderdale
Florida
33316
United States
GSK Investigational Site
Ft. Pierce
Florida
34982
United States
GSK Investigational Site
Miami
Florida
33137
United States
GSK Investigational Site
Oakland Park
Florida
33309
United States
GSK Investigational Site
Orlando
Florida
32803
United States
GSK Investigational Site
West Palm Beach
Florida
33407
United States
GSK Investigational Site
Atlanta
Georgia
30339
United States
GSK Investigational Site
Augusta
Georgia
30912
United States
GSK Investigational Site
Macon
Georgia
31201
United States
GSK Investigational Site
Savannah
Georgia
31401
United States
GSK Investigational Site
Indianapolis
Indiana
46202
United States
GSK Investigational Site
Boston
Massachusetts
02111
United States
GSK Investigational Site
Minneapolis
Minnesota
55415
United States
GSK Investigational Site
Kansas City
Missouri
64111
United States
GSK Investigational Site
Omaha
Nebraska
68198
United States
GSK Investigational Site
Las Vegas
Nevada
89106
United States
GSK Investigational Site
Hillsborough
New Jersey
08844
United States
GSK Investigational Site
Neptune City
New Jersey
07753
United States
GSK Investigational Site
Albany
New York
12209
United States
GSK Investigational Site
Buffalo
New York
14201
United States
GSK Investigational Site
New York
New York
10065
United States
GSK Investigational Site
Valhalla
New York
10595
United States
GSK Investigational Site
Chapel Hill
North Carolina
27599
United States
GSK Investigational Site
Providence
Rhode Island
02906
United States
GSK Investigational Site
Charleston
South Carolina
29425
United States
GSK Investigational Site
Austin
Texas
78751
United States
GSK Investigational Site
Dallas
Texas
75246
United States
GSK Investigational Site
Annandale
Virginia
22003
United States
GSK Investigational Site
Vancouver
British Columbia
V6Z 2C7
Canada
GSK Investigational Site
Vancouver
British Columbia
V6Z 2T1
Canada
GSK Investigational Site
Toronto
Ontario
M4N 3M5
Canada
GSK Investigational Site
Toronto
Ontario
M4T 3A7
Canada
GSK Investigational Site
Toronto
Ontario
M5G 1K2
Canada
GSK Investigational Site
Montreal
Quebec
H2L 4E9
Canada
GSK Investigational Site
Montreal
Quebec
H2L 4P9
Canada
GSK Investigational Site
Montreal
Quebec
H3A 1T1
Canada
Derived
Patel P, Xue Z, King KS, Parham L, Ford S, Lou Y, Bakshi KK, Sutton K, Margolis D, Hughes AR, Spreen WR. Evaluation of the effect of UGT1A1 polymorphisms on the pharmacokinetics of oral and long-acting injectable cabotegravir. J Antimicrob Chemother. 2020 Aug 1;75(8):2240-2248. doi: 10.1093/jac/dkaa147.
Margolis DA, Brinson CC, Smith GHR, de Vente J, Hagins DP, Eron JJ, Griffith SK, Clair MHS, Stevens MC, Williams PE, Ford SL, Stancil BS, Bomar MM, Hudson KJ, Smith KY, Spreen WR; LAI116482 Study Team. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial. Lancet Infect Dis. 2015 Oct;15(10):1145-1155. doi: 10.1016/S1473-3099(15)00152-8. Epub 2015 Jul 19.
FG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
FG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
FG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
FG00060 subjects
FG00160 subjects
FG00261 subjects
FG00362 subjects
COMPLETED
FG00052 subjects
FG00153 subjects
FG00255 subjects
FG00347 subjects
NOT COMPLETED
FG0008 subjects
FG0017 subjects
FG0026 subjects
FG00315 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Lack of Efficacy
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0037 subjects
Maintenance Phase (Week 24 to Week 96)
Type
Comment
Milestone Data
STARTED
FG00052 subjects
FG00153 subjects
FG00255 subjects
FG00347 subjects
COMPLETED
FG00046 subjects
FG00148 subjects
FG00252 subjects
FG00341 subjects
NOT COMPLETED
FG0006 subjects
FG0015 subjects
FG0023 subjects
FG0036 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG003
Open-label (Week 96 to Week 324)
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG00147 subjects1 participant completed study as per protocol at Week 96 and opted to not enter open-label phase
FG00251 subjects1 participant completed study as per protocol at Week 96 and opted to not enter open-label phase
FG0030 subjectsParticipants completed study at Week 96 and did not enter open-label phase
COMPLETED
FG00030 subjects
FG00135 subjects
FG00243 subjects
FG0030 subjects
NOT COMPLETED
FG00016 subjects
FG00112 subjects
FG0028 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
BG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
BG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
BG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00160
BG00261
BG00362
BG004243
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00034.0± 9.91
BG00134.4± 10.24
BG00236.2± 10.15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
African American (Af Am)/African Heritage (Her)
Title
Measurements
BG00021
BG00117
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
ITT-E Population
Posted
Number
95% Confidence Interval
Percentage of participants
Week 48
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Units
Counts
Participants
OG00060
OG00160
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG00080(70 to 90)
OG00180(70 to 90)
OG00287(78 to 95)
OG003
Secondary
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
ITT-E Population
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
ITT-E Population.Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
On-treatment Phenotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
On-treatment Genotypic resistance Population
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized.
ITT-E Population. Only participants who were dispensed and returned drug on scheduled visits were included in the analysis (represented by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
ITT-E Population
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16 and Week 24
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Maintenance Safety Population
Posted
Count of Participants
Participants
Week 24 to Week 96
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Maintenance Safety Population
Posted
Count of Participants
Participants
Week 24 to Week 96
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Maintenance Safety Population
Posted
Count of Participants
Participants
Week 24 to Week 96
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With AEs and SAEs Over Time
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Safety Population
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Safety Population
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Secondary
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Safety Population
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Safety Population
Posted
Number
Percentage of participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.
Safety Population. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 324
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
Secondary
Number of Participants With AEs and SAEs-Induction Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.
Safety Population
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Safety Population
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Safety Population
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Safety Population
Posted
Number
Percentage of participants
Up to Week 24
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Maintenance Safety Population
Posted
Number
Percentage of participants
Week 24 to Week 96
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data
PK Summary Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*micrograms per milliliter
pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Secondary
Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
PK Summary Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
PK Summary Population. Only those participants with data available at the specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
AUC(0 to Tau) for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized
Posted
pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Cmax for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized
Posted
pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Secondary
Ctau for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized
Posted
pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
ID
Title
Description
OG000
GSK1265744 10 mg
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Time Frame
Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase.
Description
Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
GSK1265744 10 mg (Induction Phase)
Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
0
60
2
60
46
60
EG001
GSK1265744 30 mg (Induction Phase)
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
0
60
0
60
47
60
EG002
GSK1265744 60 mg (Induction Phase)
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
0
61
2
61
50
61
EG003
Efavirenz 600 mg (Induction Phase)
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.
0
62
2
62
54
62
EG004
GSK1265744 10 mg (Maintenance Phase)
Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.
0
52
5
52
35
52
EG005
GSK1265744 30 mg (Maintenance Phase)
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.
0
53
5
53
44
53
EG006
GSK1265744 60 mg (Maintenance Phase)
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.
0
55
5
55
47
55
EG007
Efavirenz 600 mg (Maintenance Phase)
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily.
0
47
2
47
33
47
EG008
GSK1265744 10 mg (Open-label Phase)
Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.
0
46
7
46
32
46
EG009
GSK1265744 30 mg (Open-label Phase)
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.
1
47
8
47
38
47
EG010
GSK1265744 60 mg (Open-label Phase)
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.
1
51
5
51
40
51
EG011
Efavirenz 600mg (Open-label Phase)
Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial flutter
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG0030 events0 affected62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
Atrial thrombosis
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Appendiceal abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Shigella infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Viral infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Liver function test increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Burkitt's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Mania
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Adnexa uteri mass
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0015 events4 affected60 at risk
EG0022 events2 affected61 at risk
EG0031 events1 affected62 at risk
EG0043 events3 affected52 at risk
EG0051 events1 affected53 at risk
EG0064 events4 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
Palpitations
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Type V hyperlipidaemia
Congenital, familial and genetic disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0005 events5 affected60 at risk
EG0014 events4 affected60 at risk
EG0024 events4 affected61 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anogenital dysplasia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0011 events1 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG00010 events10 affected60 at risk
EG0017 events7 affected60 at risk
EG00213 events11 affected61 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0013 events3 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0012 events2 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected60 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG00015 events14 affected60 at risk
EG00114 events11 affected60 at risk
EG00213 events11 affected61 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0012 events2 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0014 events4 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0024 events4 affected61 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0007 events6 affected60 at risk
EG0018 events5 affected60 at risk
EG0028 events7 affected61 at risk
EG003
Feeling drunk
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Feeling hot
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 events1 affected60 at risk
EG0013 events3 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0011 events1 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anal chlamydia infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Body tinea
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0015 events5 affected60 at risk
EG0024 events3 affected61 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Ear infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Eye infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0005 events5 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Gonorrhoea
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0009 events9 affected60 at risk
EG0012 events2 affected60 at risk
EG00212 events8 affected61 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Otitis media
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Proctitis gonococcal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0004 events3 affected60 at risk
EG0013 events2 affected60 at risk
EG0025 events5 affected61 at risk
EG003
Skin infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Syphilis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0011 events1 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0018 events8 affected60 at risk
EG00210 events9 affected61 at risk
EG003
Urethritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Urethritis chlamydial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Urethritis gonococcal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Viral infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Exposure to communicable disease
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Lipase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Weight decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0013 events2 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events1 affected60 at risk
EG0012 events2 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0005 events5 affected60 at risk
EG0014 events4 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0023 events2 affected61 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0010 events0 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0014 events3 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0005 events5 affected60 at risk
EG0015 events5 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG00014 events13 affected60 at risk
EG00117 events13 affected60 at risk
EG00214 events13 affected61 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0012 events2 affected60 at risk
EG0024 events2 affected61 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0015 events5 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0013 events3 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0015 events5 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0016 events6 affected60 at risk
EG0027 events7 affected61 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0007 events5 affected60 at risk
EG0015 events5 affected60 at risk
EG0024 events4 affected61 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0011 events1 affected60 at risk
EG0024 events2 affected61 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0014 events4 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected60 at risk
EG0013 events3 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0015 events4 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0022 events2 affected61 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected61 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0005 events3 affected60 at risk
EG0012 events2 affected60 at risk
EG0023 events3 affected61 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Hot flush
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected61 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
ViiV Healthcare
866-435-7343
GSKClinicalSupportHD@gsk.com
ID
Term
D007239
Infections
D000163
Acquired Immunodeficiency Syndrome
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012897
Slow Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C584914
cabotegravir
C098320
efavirenz
D000068696
Rilpivirine
C106538
abacavir
D019259
Lamivudine
Ancestor Terms
ID
Term
D009570
Nitriles
D009930
Organic Chemicals
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D016047
Zalcitabine
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D015224
Dideoxynucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
0 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Lost to Follow-up
FG0005 subjects
FG0014 subjects
FG0025 subjects
FG0030 subjects
Site closed
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Lack of Efficacy
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Adverse Event
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
35.6
± 12.30
BG00435.1± 10.68
4
BG0031
BG00410
Male
BG00057
BG00158
BG00257
BG00361
BG004233
18
BG00320
BG00476
American Indian or Alaskan Native (Nat)
Title
Measurements
BG0000
BG0010
BG0022
BG0032
BG0044
Asian-Central/South Asian Her
Title
Measurements
BG0001
BG0011
BG0021
BG0030
BG0043
Asian-Japanese/East Asian/South East Asian Her
Title
Measurements
BG0000
BG0011
BG0022
BG0030
BG0043
White
Title
Measurements
BG00037
BG00139
BG00236
BG00339
BG004151
Af Am/Af Her and Asian and White
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
Af Am/Af Her & Nat Hawaiian/other Pacific islander
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
Af Am/Af Her & White
Title
Measurements
BG0000
BG0012
BG0020
BG0030
BG0042
American Indian or Alaskan Native & White
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
Asian & White
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0041
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
62
71
(60 to 82)
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Week 2
Title
Measurements
OG00087
OG00180
OG00284
OG003
Week 4
Title
Measurements
OG00093
OG00193
OG00293
OG003
Week 8
Title
Measurements
OG00093
OG00192
OG00292
OG003
Week 12
Title
Measurements
OG00090
OG00185
OG00289
OG003
Week 16
Title
Measurements
OG00093
OG00187
OG00293
OG003
Week 24
Title
Measurements
OG00093
OG00187
OG00292
OG003
Week 26
Title
Measurements
OG00080
OG00180
OG00287
OG003
Week 28
Title
Measurements
OG00085
OG00183
OG00285
OG003
Week 32
Title
Measurements
OG00087
OG00185
OG00289
OG003
Week 36
Title
Measurements
OG00087
OG00185
OG00290
OG003
Week 40
Title
Measurements
OG00087
OG00185
OG00290
OG003
Week 48
Title
Measurements
OG00083
OG00185
OG00289
OG003
Week 60
Title
Measurements
OG00080
OG00177
OG00287
OG003
Week 72
Title
Measurements
OG00077
OG00175
OG00285
OG003
Week 84
Title
Measurements
OG00077
OG00177
OG00285
OG003
Week 96
Title
Measurements
OG00075
OG00177
OG00285
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=59, 56, 57, 55
ParticipantsOG00059
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Week 12; n=58, 52, 57, 51
ParticipantsOG00058
ParticipantsOG00152
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 56, 47
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00256
ParticipantsOG00347
Week 24; n=56, 53, 56, 48
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00348
Week 26; n=48, 50, 53, 44
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00344
Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 40; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 48, 53, 44
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00253
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Week 2
Title
Measurements
OG00048
OG00150
OG00251
OG003
Week 4
Title
Measurements
OG00080
OG00178
OG00270
OG003
Week 8
Title
Measurements
OG00090
OG00183
OG00287
OG003
Week 12
Title
Measurements
OG00088
OG00175
OG00282
OG003
Week 16
Title
Measurements
OG00090
OG00183
OG00287
OG003
Week 24
Title
Measurements
OG00087
OG00185
OG00287
OG003
Week 26
Title
Measurements
OG00078
OG00175
OG00285
OG003
Week 28
Title
Measurements
OG00085
OG00178
OG00285
OG003
Week 32
Title
Measurements
OG00083
OG00180
OG00287
OG003
Week 36
Title
Measurements
OG00085
OG00182
OG00285
OG003
Week 40
Title
Measurements
OG00083
OG00182
OG00285
OG003
Week 48
Title
Measurements
OG00080
OG00180
OG00287
OG003
Week 60
Title
Measurements
OG00078
OG00173
OG00285
OG003
Week 72
Title
Measurements
OG00072
OG00173
OG00285
OG003
Week 84
Title
Measurements
OG00072
OG00175
OG00285
OG003
Week 96
Title
Measurements
OG00068
OG00175
OG00284
OG003
Week 108
Title
Measurements
OG00068
OG00172
OG00280
OG003
Week 120
Title
Measurements
OG00065
OG00173
OG00280
OG003
Week 132
Title
Measurements
OG00062
OG00170
OG00280
OG003
Week 144
Title
Measurements
OG00058
OG00167
OG00277
OG003
Week 156
Title
Measurements
OG00058
OG00163
OG00280
OG003
Week 168
Title
Measurements
OG00057
OG00165
OG00275
OG003
Week 180
Title
Measurements
OG00058
OG00167
OG00275
OG003
Week 192
Title
Measurements
OG00057
OG00165
OG00274
OG003
Week 204
Title
Measurements
OG00055
OG00162
OG00275
OG003
Week 216
Title
Measurements
OG00055
OG00163
OG00277
OG003
Week 228
Title
Measurements
OG00053
OG00163
OG00275
OG003
Week 240
Title
Measurements
OG00050
OG00162
OG00274
OG003
Week 252
Title
Measurements
OG00052
OG00162
OG00275
OG003
Week 264
Title
Measurements
OG00053
OG00162
OG00275
OG003
Week 276
Title
Measurements
OG00052
OG00162
OG00270
OG003
Week 288
Title
Measurements
OG00050
OG00162
OG00274
OG003
Week 300
Title
Measurements
OG00052
OG00160
OG00270
OG003
Week 312
Title
Measurements
OG00052
OG00152
OG00270
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=59, 56, 57, 55
ParticipantsOG00059
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Week 12; n=58, 52, 57, 51
ParticipantsOG00058
ParticipantsOG00152
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 56, 47
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00256
ParticipantsOG00347
Week 24; n=56, 53, 56, 48
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00348
Week 26; n=48, 50, 53, 44
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00344
Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 40; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 48, 53, 44
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00253
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
Week 192; n=36, 40, 47, 0
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 216; n=33, 39, 47, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 240; n=31, 39, 45, 0
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00245
ParticipantsOG0030
Week 252; n=31, 38, 47, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 288; n=30, 38, 45, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 300; n=31, 37, 44, 0
ParticipantsOG00031
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
Week 312; n=31, 33, 43, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00243
ParticipantsOG0030
Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG0004.424± 0.5834
OG0014.270± 0.6359
OG0024.428± 0.6418
OG003
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=59, 56, 57, 55
ParticipantsOG00059
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Week 12; n=58, 52, 57, 51
ParticipantsOG00058
ParticipantsOG00152
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 56, 47
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00256
ParticipantsOG00347
Week 24; n=56, 53, 56, 48
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00348
Week 26; n=48, 50, 53, 44
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00344
Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 40; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 48, 53, 44
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00253
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
Week 192; n=36, 40, 47, 0
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 216; n=33, 39, 47, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 240; n=31, 39, 45, 0
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00245
ParticipantsOG0030
Week 252; n=31, 38, 47, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 288; n=30, 38, 45, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 300; n=31, 37, 44, 0
ParticipantsOG00031
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
Week 312; n=31, 33, 43, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00243
ParticipantsOG0030
Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Title
Measurements
OG000-2.534± 0.4175
OG001-2.306± 0.5937
OG002-2.504± 0.4311
OG003
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=59, 56, 57, 55
ParticipantsOG00059
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Week 12; n=58, 52, 57, 51
ParticipantsOG00058
ParticipantsOG00152
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 56, 47
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00256
ParticipantsOG00347
Week 24; n=56, 53, 56, 48
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00348
Week 26; n=48, 50, 53, 44
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00344
Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 40; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 48, 53, 44
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00253
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
Week 192; n=36, 40, 47, 0
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 216; n=33, 39, 47, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 240; n=31, 39, 45, 0
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00245
ParticipantsOG0030
Week 252; n=31, 38, 47, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 288; n=30, 38, 45, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 300; n=31, 37, 44, 0
ParticipantsOG00031
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
Week 312; n=31, 33, 43, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00243
ParticipantsOG0030
Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
CDC Class A to CDC Class C
Title
Measurements
OG0001
OG0011
OG0020
OG0030
CDC Class B to CDC Class C
Title
Measurements
OG0000
OG0010
OG0020
OG003
CDC Class C to new CDC Class C
Title
Measurements
OG0000
OG0010
OG0020
OG003
CDC Class A, B or C to Death
Title
Measurements
OG0000
OG0011
OG0021
OG003
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG000445.5± 155.60
OG001444.9± 190.98
OG002459.0± 170.64
OG003
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=58, 56, 57, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 56, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00256
ParticipantsOG00349
Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Week 28; n=49, 52, 52, 45
ParticipantsOG00049
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 40; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Title
Measurements
OG00092.6± 112.44
OG00179.5± 118.15
OG00291.7± 127.92
OG003
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=58, 56, 57, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 56, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00256
ParticipantsOG00349
Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Week 28; n=49, 52, 52, 45
ParticipantsOG00049
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 40; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 144; n=37, 45, 46, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG0030
Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
Week 192; n=35, 40, 47, 0
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 216; n=33, 39, 47, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 240; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 252; n=31, 38, 47, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Week 276; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
Week 288; n=30, 38, 45, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Week 300; n=30, 37, 44, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
Week 312; n=30, 34, 43, 0
ParticipantsOG00030
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG0006
OG0012
OG0022
OG0035
Title
Denominators
Categories
INI, GSK1265744; Resistant; n=5, 1, 2, 2
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
Title
Measurements
OG0002
OG0010
OG0021
OG003
INI, GSK1265744; Sensitive; n=5, 1, 2, 2
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
INI, RAL; Resistant; n=5, 1, 2, 2
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
INI, RAL; Sensitive; n=5, 1, 2, 2
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
NNRTI, DLV; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, DLV; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, EFV; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, EFV; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, ETR; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, ETR; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, NVP; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, NVP; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, RPV; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NNRTI, RPV; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, 3TC; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, 3TC; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ABC; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ABC; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ABC; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, FTC; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, FTC; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, TDF; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, TDF; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, TDF; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ZDV; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ZDV; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, d4T; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, d4T; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ddI; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ddI; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
NRTI, ddI; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, ATV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, ATV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, DRV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, DRV/r; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, DRV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, FPV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, FPV/r; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, FPV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, IDV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, IDV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, LPV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, LPV/r; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, LPV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, NFV; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, NFV; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, RTV; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, RTV; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, SQV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, SQV/r; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, SQV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, TPV/r; Resistant; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, TPV/r; Partially sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
PI, TPV/r; Sensitive; n=6, 2, 2, 5
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG0006
OG0012
OG0022
OG0035
Title
Denominators
Categories
Any INI mutation
Title
Measurements
OG0003
OG0010
OG0021
OG0030
Any mutation to other classes
Title
Measurements
OG0004
OG0010
OG0021
OG003
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00057
OG00155
OG00256
OG00352
Title
Denominators
Categories
Baseline; n=57, 55, 56, 52
ParticipantsOG00057
ParticipantsOG00155
ParticipantsOG00256
ParticipantsOG00352
Title
Measurements
OG00053
OG00151
OG00255
OG003
Week 4; n=54, 52, 53, 50
ParticipantsOG00054
ParticipantsOG00152
ParticipantsOG00253
ParticipantsOG00350
Week 8; n=53, 50, 56, 48
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00256
ParticipantsOG00348
Week 12; n=55, 48, 53, 48
ParticipantsOG00055
ParticipantsOG00148
ParticipantsOG00253
ParticipantsOG00348
Week 16; n=53, 51, 53, 44
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00253
ParticipantsOG00344
Week 20; n=51, 49, 55, 44
ParticipantsOG00051
ParticipantsOG00149
ParticipantsOG00255
ParticipantsOG00344
Week 24; n=51, 46, 51, 43
ParticipantsOG00051
ParticipantsOG00146
ParticipantsOG00251
ParticipantsOG00343
Week 28; n=49, 48, 53, 41
ParticipantsOG00049
ParticipantsOG00148
ParticipantsOG00253
ParticipantsOG00341
Week 32; n=47, 48, 55, 41
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00255
ParticipantsOG00341
Week 36; n=46, 48, 50, 41
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00250
ParticipantsOG00341
Week 40; n=38, 35, 45, 39
ParticipantsOG00038
ParticipantsOG00135
ParticipantsOG00245
ParticipantsOG00339
Week 48; n=33, 37, 45, 35
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00245
ParticipantsOG00335
Week 60; n=38, 38, 40, 37
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00240
ParticipantsOG00337
Week 72; n=35, 37, 44, 32
ParticipantsOG00035
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG00332
Week 84; n=36, 39, 42, 33
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00242
ParticipantsOG00333
Week 96; n=31, 36, 33, 0
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG0030
Week 108; n=23, 23, 29, 0
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00229
ParticipantsOG0030
Week 120; n=30, 38, 41, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00241
ParticipantsOG0030
Week 132; n=29, 32, 40, 0
ParticipantsOG00029
ParticipantsOG00132
ParticipantsOG00240
ParticipantsOG0030
Week 144; n=33, 34, 43, 0
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
Week 156; n=31, 28, 39, 0
ParticipantsOG00031
ParticipantsOG00128
ParticipantsOG00239
ParticipantsOG0030
Week 168; n=29, 33, 41, 0
ParticipantsOG00029
ParticipantsOG00133
ParticipantsOG00241
ParticipantsOG0030
Week 180; n=26, 29, 39, 0
ParticipantsOG00026
ParticipantsOG00129
ParticipantsOG00239
ParticipantsOG0030
Week 192; n=30, 30, 39, 0
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG00239
ParticipantsOG0030
Week 204; n=29, 32, 38, 0
ParticipantsOG00029
ParticipantsOG00132
ParticipantsOG00238
ParticipantsOG0030
Week 216; n=29, 30, 37, 0
ParticipantsOG00029
ParticipantsOG00130
ParticipantsOG00237
ParticipantsOG0030
Week 228; n=27, 34, 40, 0
ParticipantsOG00027
ParticipantsOG00134
ParticipantsOG00240
ParticipantsOG0030
Week 240; n=28, 26, 41, 0
ParticipantsOG00028
ParticipantsOG00126
ParticipantsOG00241
ParticipantsOG0030
Week 252; n=23, 26, 33, 0
ParticipantsOG00023
ParticipantsOG00126
ParticipantsOG00233
ParticipantsOG0030
Week 264; n=15, 18, 24, 0
ParticipantsOG00015
ParticipantsOG00118
ParticipantsOG00224
ParticipantsOG0030
Week 276; n=14, 14, 21, 0
ParticipantsOG00014
ParticipantsOG00114
ParticipantsOG00221
ParticipantsOG0030
Week 288; n=12, 14, 18, 0
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00218
ParticipantsOG0030
Week 300; n=12, 13, 20, 0
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00220
ParticipantsOG0030
Week 312; n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Week 16
Title
Measurements
OG00090(82 to 98)
OG00183(74 to 93)
OG00287(78 to 95)
OG00374(63 to 85)
Week 24
Title
Measurements
OG00087(78 to 95)
OG00185(76 to 94)
OG00287(78 to 95)
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00052
OG00153
OG00255
OG00347
Title
Denominators
Categories
Week 24
Title
Measurements
OG00096
OG00194
OG00296
OG00396
Week 26
Title
Measurements
OG00090
OG00185
OG00295
OG003
Week 28
Title
Measurements
OG00098
OG00189
OG00295
OG003
Week 32
Title
Measurements
OG00096
OG00191
OG00296
OG003
Week 36
Title
Measurements
OG00098
OG00192
OG00295
OG003
Week 40
Title
Measurements
OG00096
OG00192
OG00295
OG003
Week 48
Title
Measurements
OG00092
OG00191
OG00296
OG003
Week 60
Title
Measurements
OG00090
OG00183
OG00295
OG003
Week 72
Title
Measurements
OG00083
OG00183
OG00295
OG003
Week 84
Title
Measurements
OG00083
OG00185
OG00295
OG003
Week 96
Title
Measurements
OG00079
OG00185
OG00293
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00052
OG00153
OG00255
OG00347
Title
Denominators
Categories
Any AE
Title
Measurements
OG00040
OG00150
OG00250
OG00335
Any SAE
Title
Measurements
OG0005
OG0015
OG0025
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00052
OG00153
OG00255
OG00347
Title
Denominators
Categories
ALT; Grade 1
Title
Measurements
OG0009
OG00112
OG00217
OG0036
ALT; Grade 2
Title
Measurements
OG0006
OG0016
OG0025
OG003
ALT; Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALT; Grade 4
Title
Measurements
OG0001
OG0011
OG0020
OG003
Albumin; Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
Albumin; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP; Grade 1
Title
Measurements
OG0002
OG0011
OG0024
OG003
ALP; Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALP; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST; Grade 1
Title
Measurements
OG0005
OG00113
OG00213
OG003
AST; Grade 2
Title
Measurements
OG0005
OG0018
OG0025
OG003
AST; Grade 3
Title
Measurements
OG0002
OG0010
OG0022
OG003
AST; Grade 4
Title
Measurements
OG0002
OG0011
OG0020
OG003
CO2/bicarbonate; Grade 1
Title
Measurements
OG0006
OG00114
OG0029
OG003
CO2/bicarbonate; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cholesterol; Grade 1
Title
Measurements
OG00017
OG00117
OG00219
OG003
Cholesterol; Grade 2
Title
Measurements
OG0006
OG00112
OG00215
OG003
Cholesterol; Grade 3
Title
Measurements
OG0003
OG0010
OG0023
OG003
Cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
CK; Grade 1
Title
Measurements
OG0008
OG0019
OG00211
OG003
CK; Grade 2
Title
Measurements
OG0002
OG0014
OG0024
OG003
CK; Grade 3
Title
Measurements
OG0003
OG0012
OG0024
OG003
CK; Grade 4
Title
Measurements
OG0006
OG0016
OG0025
OG003
Creatinine; Grade 1
Title
Measurements
OG0001
OG0011
OG0022
OG003
Creatinine; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Creatinine; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose; Grade 1
Title
Measurements
OG00017
OG00117
OG00220
OG003
Glucose; Grade 2
Title
Measurements
OG00014
OG00110
OG00211
OG003
Glucose; Grade 3
Title
Measurements
OG0000
OG0010
OG0022
OG003
Glucose; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
LDL cholesterol; Grade 1
Title
Measurements
OG00014
OG00116
OG00213
OG003
LDL cholesterol; Grade 2
Title
Measurements
OG0006
OG00111
OG00214
OG003
LDL cholesterol; Grade 3
Title
Measurements
OG0004
OG0012
OG0027
OG003
LDL cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase; Grade 1
Title
Measurements
OG0009
OG0019
OG0028
OG003
Lipase; Grade 2
Title
Measurements
OG0009
OG0018
OG00211
OG003
Lipase; Grade 3
Title
Measurements
OG0005
OG0011
OG0026
OG003
Lipase; Grade 4
Title
Measurements
OG0002
OG0010
OG0022
OG003
Inorganic phosphorus; Grade 1
Title
Measurements
OG0005
OG0013
OG0029
OG003
Inorganic phosphorus; Grade 2
Title
Measurements
OG00010
OG00111
OG0025
OG003
Inorganic phosphorus; Grade 3
Title
Measurements
OG0002
OG0011
OG0025
OG003
Inorganic phosphorus; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 1
Title
Measurements
OG00012
OG0017
OG0028
OG003
Potassium; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 1
Title
Measurements
OG00014
OG00112
OG00216
OG003
Sodium; Grade 2
Title
Measurements
OG0002
OG0011
OG0020
OG003
Sodium; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total bilirubin; Grade 1
Title
Measurements
OG0007
OG0011
OG0028
OG003
Total bilirubin; Grade 2
Title
Measurements
OG0002
OG0013
OG0024
OG003
Total bilirubin; Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Total bilirubin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides; Grade 2
Title
Measurements
OG0001
OG0014
OG0023
OG003
Triglycerides; Grade 3
Title
Measurements
OG0001
OG0010
OG0023
OG003
Triglycerides; Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00052
OG00153
OG00255
OG00347
Title
Denominators
Categories
APTT; Grade 1
Title
Measurements
OG0005
OG0015
OG0025
OG0035
APTT; Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
APTT; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
APTT; Grade 4
Title
Measurements
OG0001
OG0011
OG0021
OG003
Hemoglobin; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hemoglobin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
INR; Grade 1
Title
Measurements
OG0002
OG0014
OG0020
OG003
INR; Grade 2
Title
Measurements
OG0000
OG0011
OG0021
OG003
INR; Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
INR; Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelet count; Grade 1
Title
Measurements
OG0004
OG0010
OG0024
OG003
Platelet count; Grade 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelet count; Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelet count; Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
PT; Grade 1
Title
Measurements
OG0001
OG0013
OG0020
OG003
PT; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
PT; Grade 3
Title
Measurements
OG0000
OG0011
OG0021
OG003
PT; Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Total neutrophils; Grade 1
Title
Measurements
OG0007
OG0019
OG00210
OG003
Total neutrophils; Grade 2
Title
Measurements
OG0005
OG0012
OG0023
OG003
Total neutrophils; Grade 3
Title
Measurements
OG0001
OG0010
OG0021
OG003
Total neutrophils; Grade 4
Title
Measurements
OG0001
OG0011
OG0023
OG003
WBC count; Grade 1
Title
Measurements
OG0002
OG0015
OG0022
OG003
WBC count; Grade 2
Title
Measurements
OG0001
OG0011
OG0021
OG003
WBC count; Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC count; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Any AE
Title
Measurements
OG00057
OG00157
OG00260
OG00360
Any SAE
Title
Measurements
OG00013
OG00112
OG00211
OG003
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
ALT; Grade 1
Title
Measurements
OG0009
OG00112
OG00219
OG0038
ALT; Grade 2
Title
Measurements
OG0006
OG0016
OG0025
OG003
ALT; Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALT; Grade 4
Title
Measurements
OG0001
OG0011
OG0022
OG003
Albumin; Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
Albumin; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP; Grade 1
Title
Measurements
OG0002
OG0011
OG0024
OG003
ALP; Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALP; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST; Grade 1
Title
Measurements
OG0007
OG00113
OG00215
OG003
AST; Grade 2
Title
Measurements
OG0006
OG0018
OG0025
OG003
AST; Grade 3
Title
Measurements
OG0002
OG0010
OG0024
OG003
AST; Grade 4
Title
Measurements
OG0002
OG0011
OG0020
OG003
CO2/bicarbonate; Grade 1
Title
Measurements
OG0006
OG00114
OG0029
OG003
CO2/bicarbonate; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cholesterol; Grade 1
Title
Measurements
OG00017
OG00117
OG00219
OG003
Cholesterol; Grade 2
Title
Measurements
OG0007
OG00112
OG00215
OG003
Cholesterol; Grade 3
Title
Measurements
OG0003
OG0010
OG0023
OG003
Cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
CK; Grade 1
Title
Measurements
OG0009
OG00110
OG00212
OG003
CK; Grade 2
Title
Measurements
OG0002
OG0014
OG0024
OG003
CK; Grade 3
Title
Measurements
OG0003
OG0012
OG0024
OG003
CK; Grade 4
Title
Measurements
OG0007
OG0016
OG0025
OG003
Creatinine; Grade 1
Title
Measurements
OG0001
OG0011
OG0022
OG003
Creatinine; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Creatinine; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose; Grade 1
Title
Measurements
OG00019
OG00118
OG00221
OG003
Glucose; Grade 2
Title
Measurements
OG00014
OG00110
OG00211
OG003
Glucose; Grade 3
Title
Measurements
OG0000
OG0010
OG0022
OG003
Glucose; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
LDL cholesterol; Grade 1
Title
Measurements
OG00014
OG00117
OG00213
OG003
LDL cholesterol; Grade 2
Title
Measurements
OG0007
OG00111
OG00214
OG003
LDL cholesterol; Grade 3
Title
Measurements
OG0004
OG0012
OG0027
OG003
LDL cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase; Grade 1
Title
Measurements
OG00011
OG0019
OG0029
OG003
Lipase; Grade 2
Title
Measurements
OG0009
OG0018
OG00211
OG003
Lipase; Grade 3
Title
Measurements
OG0005
OG0012
OG0026
OG003
Lipase; Grade 4
Title
Measurements
OG0002
OG0010
OG0022
OG003
Inorganic phosphorus; Grade 1
Title
Measurements
OG0005
OG0013
OG00210
OG003
Inorganic phosphorus; Grade 2
Title
Measurements
OG00011
OG00111
OG0026
OG003
Inorganic phosphorus; Grade 3
Title
Measurements
OG0002
OG0011
OG0025
OG003
Inorganic phosphorus; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 1
Title
Measurements
OG00014
OG0017
OG0028
OG003
Potassium; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 1
Title
Measurements
OG00014
OG00112
OG00216
OG003
Sodium; Grade 2
Title
Measurements
OG0002
OG0011
OG0020
OG003
Sodium; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total bilirubin; Grade 1
Title
Measurements
OG0007
OG0011
OG0028
OG003
Total bilirubin; Grade 2
Title
Measurements
OG0002
OG0013
OG0024
OG003
Total bilirubin; Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Total bilirubin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides; Grade 2
Title
Measurements
OG0001
OG0014
OG0023
OG003
Triglycerides; Grade 3
Title
Measurements
OG0001
OG0010
OG0023
OG003
Triglycerides; Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
APTT; Grade 1
Title
Measurements
OG0005
OG0015
OG0025
OG0035
APTT; Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
APTT; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
APTT; Grade 4
Title
Measurements
OG0001
OG0011
OG0021
OG003
Hemoglobin; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hemoglobin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
INR; Grade 1
Title
Measurements
OG0002
OG0014
OG0020
OG003
INR; Grade 2
Title
Measurements
OG0000
OG0011
OG0021
OG003
INR; Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
INR; Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelet count; Grade 1
Title
Measurements
OG0004
OG0010
OG0024
OG003
Platelet count; Grade 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelet count; Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelet count; Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
PT; Grade 1
Title
Measurements
OG0001
OG0013
OG0020
OG003
PT; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
PT; Grade 3
Title
Measurements
OG0000
OG0011
OG0021
OG003
PT; Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Total neutrophils; Grade 1
Title
Measurements
OG0007
OG0019
OG00210
OG003
Total neutrophils; Grade 2
Title
Measurements
OG0005
OG0012
OG0023
OG003
Total neutrophils; Grade 3
Title
Measurements
OG0001
OG0010
OG0021
OG003
Total neutrophils; Grade 4
Title
Measurements
OG0001
OG0011
OG0023
OG003
WBC count; Grade 1
Title
Measurements
OG0002
OG0015
OG0022
OG003
WBC count; Grade 2
Title
Measurements
OG0001
OG0011
OG0021
OG003
WBC count; Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC count; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
ALT; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG00023.9± 12.38
OG00128.1± 17.65
OG00228.5± 20.60
OG003
ALT; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
ALT; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
ALT; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
ALT; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
ALT; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
ALT; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
ALT; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
ALT; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
ALT; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
ALT; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
ALT; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
ALT; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
ALT; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
ALT; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
ALT; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
ALT; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
ALT; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
AST; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
AST; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
AST; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
AST; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
AST; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
AST; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
AST; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
AST; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
AST; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
AST; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
AST; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
AST; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
AST; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
AST; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
AST; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
AST; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
AST; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
AST; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
CK; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
CK; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
CK; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
CK; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
CK; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
CK; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
CK; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
CK; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
CK; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
CK; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
CK; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
CK; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
CK; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
CK; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
CK; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
CK; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
CK; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
CK; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Creatinine; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG00080.4± 13.69
OG00180.5± 13.55
OG00279.9± 14.11
OG003
Creatinine; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
Creatinine; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Creatinine; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
Creatinine; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Creatinine; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Creatinine; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
Creatinine; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Creatinine; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Creatinine; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Creatinine; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Creatinine; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
Creatinine; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
Creatinine; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Creatinine; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
Creatinine; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
Creatinine; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Creatinine; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
T. Bilirubin; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
T. Bilirubin; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
T. Bilirubin; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
T. Bilirubin; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
T. Bilirubin; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
T. Bilirubin; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
T. Bilirubin; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
T. Bilirubin; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
T. Bilirubin; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
T. Bilirubin; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
T. Bilirubin; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
T. Bilirubin; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
T. Bilirubin; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
T. Bilirubin; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
T. Bilirubin; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
T. Bilirubin; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
T. Bilirubin; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
T. Bilirubin; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG000131.0± 28.18
OG001135.2± 41.33
OG002128.3± 33.51
OG003
Week 2; n=1, 1, 0, 3
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0033
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=2, 1, 1, 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Week 16; n=55, 53, 56, 49
ParticipantsOG00055
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00349
Week 20; n=2, 0, 0, 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Week 24; n=52, 53, 55, 46
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00346
Week 26; n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 40; n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 48; n=51, 50, 54, 44
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=0, 0, 0, 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG000141.9± 12.46
OG001143.2± 10.66
OG002146.6± 13.41
OG003
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
Week 40; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 47, 52, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
T. neutrophils; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Title
Measurements
OG0002.643± 1.1237
OG0012.891± 1.4383
OG0022.487± 1.0240
OG003
T. neutrophils; Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
T. neutrophils; Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
T. neutrophils; Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
T. neutrophils; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
T. neutrophils; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
T. neutrophils; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
T. neutrophils; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
T. neutrophils; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
T. neutrophils; Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
T. neutrophils; Week 32; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
T. neutrophils; Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
T. neutrophils; Week 40; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
T. neutrophils; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
T. neutrophils; Week 60; n=48, 47, 52, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00344
T. neutrophils; Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
T. neutrophils; Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
T. neutrophils; Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
Platelet count; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
Platelet count; Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Platelet count; Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Platelet count; Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
Platelet count; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Platelet count; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Platelet count; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
Platelet count; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Platelet count; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Platelet count; Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Platelet count; Week 32; n=51, 52, 55, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
Platelet count; Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
Platelet count; Week 40; n=51, 53, 54, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00345
Platelet count; Week 48; n=51, 52, 53, 44
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00253
ParticipantsOG00344
Platelet count; Week 60; n=48, 47, 51, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00251
ParticipantsOG00344
Platelet count; Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Platelet count; Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
Platelet count; Week 96; n=46, 45, 51, 41
ParticipantsOG00046
ParticipantsOG00145
ParticipantsOG00251
ParticipantsOG00341
WBC count; Baseline; n=60, 60, 61, 62
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
ParticipantsOG00362
WBC count; Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
WBC count; Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
WBC count; Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
WBC count; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
WBC count; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
WBC count; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
WBC count; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
WBC count; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
WBC count; Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
WBC count; Week 32; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
WBC count; Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
WBC count; Week 40; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
WBC count; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
WBC count; Week 60; n=48, 47, 52, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00344
WBC count; Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
WBC count; Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
WBC count; Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
ALT; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
Title
Measurements
OG0000.1± 7.47
OG001-2.1± 12.74
OG002-1.5± 14.75
OG003
ALT; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
ALT; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
ALT; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
ALT; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
ALT; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
ALT; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
ALT; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
ALT; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
ALT; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
ALT; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
ALT; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
ALT; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
ALT; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
ALT; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
ALT; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
ALT; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
ALT; Week 108; n=43, 46, 48, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG0030
ALT; Week 120; n=40, 45, 48, 0
ParticipantsOG00040
ParticipantsOG00145
ParticipantsOG00248
ParticipantsOG0030
ALT; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
ALT; Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
ALT; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 192; n=36, 39, 47, 0
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 216; n=33, 39, 46, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
ALT; Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 240; n=30, 39, 46, 0
ParticipantsOG00030
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
ALT; Week 252; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
ALT; Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
ALT; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
ALT; Week 288; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
ALT; Week 300; n=30, 37, 44, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
ALT; Week 312; n=31, 34, 43, 0
ParticipantsOG00031
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
ALT; Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
AST; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
AST; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
AST; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
AST; Week 12; n=58, 53, 57, 50
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00350
AST; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
AST; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
AST; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
AST; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
AST; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
AST; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
AST; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
AST; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
AST; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
AST; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
AST; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
AST; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
AST; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
AST; Week 108; n=43, 46, 48, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG0030
AST; Week 120; n=40, 45, 48, 0
ParticipantsOG00040
ParticipantsOG00145
ParticipantsOG00248
ParticipantsOG0030
AST; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
AST; Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
AST; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
AST; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
AST; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
AST; Week 192; n=36, 39, 47, 0
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
AST; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
AST; Week 216; n=33, 39, 46, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
AST; Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
AST; Week 240; n=30, 39, 46, 0
ParticipantsOG00030
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
AST; Week 252; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
AST; Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
AST; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
AST; Week 288; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
AST; Week 300; n=30, 37, 44, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
AST; Week 312; n=31, 34, 43, 0
ParticipantsOG00031
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
AST; Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
CK; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
CK; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
CK; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
CK; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
CK; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
CK; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
CK; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
CK; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
CK; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
CK; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
CK; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
CK; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
CK; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
CK; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
CK; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
CK; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
CK; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
CK; Week 108; n=43, 46, 48, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG0030
CK; Week 120; n=40, 45, 48, 0
ParticipantsOG00040
ParticipantsOG00145
ParticipantsOG00248
ParticipantsOG0030
CK; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
CK; Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
CK; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
CK; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
CK; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
CK; Week 192; n=36, 39, 47, 0
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
CK; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
CK; Week 216; n=33, 39, 46, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
CK; Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
CK; Week 240; n=30, 39, 46, 0
ParticipantsOG00030
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
CK; Week 252; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
CK; Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
CK; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
CK; Week 288; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
CK; Week 300; n=30, 37, 44, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
CK; Week 312; n=31, 34, 43, 0
ParticipantsOG00031
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
CK; Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Creatinine; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
Title
Measurements
OG0003.36± 7.519
OG0012.58± 7.273
OG0024.15± 6.508
OG003
Creatinine; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Creatinine; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
Creatinine; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Creatinine; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Creatinine; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
Creatinine; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Creatinine; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Creatinine; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Creatinine; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Creatinine; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
Creatinine; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
Creatinine; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Creatinine; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
Creatinine; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
Creatinine; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Creatinine; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
Creatinine; Week 108; n=43, 46, 48, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG0030
Creatinine; Week 120; n=40, 45, 48, 0
ParticipantsOG00040
ParticipantsOG00145
ParticipantsOG00248
ParticipantsOG0030
Creatinine; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Creatinine; Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
Creatinine; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 192; n=36, 39, 47, 0
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 216; n=33, 39, 46, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
Creatinine; Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 240; n=30, 39, 46, 0
ParticipantsOG00030
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
Creatinine; Week 252; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
Creatinine; Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
Creatinine; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Creatinine; Week 288; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Creatinine; Week 300; n=30, 37, 44, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
Creatinine; Week 312; n=31, 34, 43, 0
ParticipantsOG00031
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
Creatinine; Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
T. Bilirubin; Week 2; n=58, 56, 58, 58
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00258
ParticipantsOG00358
T. Bilirubin; Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
T. Bilirubin; Week 8; n=58, 55, 57, 54
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00257
ParticipantsOG00354
T. Bilirubin; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
T. Bilirubin; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
T. Bilirubin; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
T. Bilirubin; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
T. Bilirubin; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
T. Bilirubin; Week 28; n=51, 52, 52, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
T. Bilirubin; Week 32; n=52, 53, 55, 45
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
T. Bilirubin; Week 36; n=52, 52, 55, 45
ParticipantsOG00052
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
T. Bilirubin; Week 40; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
T. Bilirubin; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
T. Bilirubin; Week 60; n=48, 47, 53, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00253
ParticipantsOG00344
T. Bilirubin; Week 72; n=47, 47, 52, 42
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00342
T. Bilirubin; Week 84; n=46, 48, 52, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
T. Bilirubin; Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
T. Bilirubin; Week 108; n=43, 46, 48, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG0030
T. Bilirubin; Week 120; n=40, 45, 48, 0
ParticipantsOG00040
ParticipantsOG00145
ParticipantsOG00248
ParticipantsOG0030
T. Bilirubin; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
T. Bilirubin; Week 144; n=37, 45, 47, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
T. Bilirubin; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 192; n=36, 39, 47, 0
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 216; n=33, 39, 46, 0
ParticipantsOG00033
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
T. Bilirubin; Week 228; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 240; n=30, 39, 46, 0
ParticipantsOG00030
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
T. Bilirubin; Week 252; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
T. Bilirubin; Week 264; n=32, 38, 47, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00247
ParticipantsOG0030
T. Bilirubin; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
T. Bilirubin; Week 288; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
T. Bilirubin; Week 300; n=30, 37, 44, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00244
ParticipantsOG0030
T. Bilirubin; Week 312; n=31, 34, 43, 0
ParticipantsOG00031
ParticipantsOG00134
ParticipantsOG00243
ParticipantsOG0030
T. Bilirubin; Week 324; n=3, 4, 3, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Week 2; n=1, 1, 0, 3
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0033
Title
Measurements
OG000-3.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG001-10.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG003-0.7± 0.58
Week 4; n=58, 57, 59, 57
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=2, 1, 1, 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Week 16; n=55, 53, 56, 49
ParticipantsOG00055
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00349
Week 20; n=2, 0, 0, 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Week 24; n=52, 53, 55, 46
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00346
Week 26; n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 40; n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 48; n=51, 50, 54, 44
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=0, 0, 0, 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Week 96; n=45, 48, 52, 40
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00340
Week 180; n=1, 0, 0, 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 204; n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 252; n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 264; n=0, 0, 1, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Title
Measurements
OG0000.1± 6.66
OG0010.0± 6.25
OG002-0.7± 6.61
OG003
Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Week 32; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
Week 40; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
Week 60; n=48, 47, 52, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00344
Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Week 144; n=37, 45, 46, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG0030
Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
Week 192; n=35, 40, 47, 0
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 216; n=32, 39, 44, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG0030
Week 228; n=31, 39, 47, 0
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 240; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Week 252; n=31, 36, 45, 0
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00245
ParticipantsOG0030
Week 264; n=32, 38, 46, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
Week 276; n=31, 38, 46, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
Week 288; n=30, 38, 44, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00244
ParticipantsOG0030
Week 300; n=30, 37, 43, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00243
ParticipantsOG0030
Week 312; n=31, 33, 42, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00242
ParticipantsOG0030
Week 324; n=3, 4, 2, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0030
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
T. neutrophils; Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Title
Measurements
OG0000.042± 1.0528
OG001-0.084± 1.4018
OG0020.104± 1.0318
OG003
T. neutrophils; Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
T. neutrophils; Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
T. neutrophils; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
T. neutrophils; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
T. neutrophils; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
T. neutrophils; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
T. neutrophils; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
T. neutrophils; Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
T. neutrophils; Week 32; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
T. neutrophils; Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
T. neutrophils; Week 40; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
T. neutrophils; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
T. neutrophils; Week 60; n=48, 47, 52, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00344
T. neutrophils; Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
T. neutrophils; Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
T. neutrophils; Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
T. neutrophils; Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
T. neutrophils; Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
T. neutrophils; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
T. neutrophils; Week 144; n=37, 45, 46, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG0030
T. neutrophils; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
T. neutrophils; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
T. neutrophils; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
T. neutrophils; Week 192; n=35, 40, 47, 0
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
T. neutrophils; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
T. neutrophils; Week 216; n=32, 39, 43, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00243
ParticipantsOG0030
T. neutrophils; Week 228; n=30, 39, 47, 0
ParticipantsOG00030
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
T. neutrophils; Week 240; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
T. neutrophils; Week 252; n=31, 36, 45, 0
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00245
ParticipantsOG0030
T. neutrophils; Week 264; n=32, 38, 46, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
T. neutrophils; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
T. neutrophils; Week 288; n=30, 38, 44, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00244
ParticipantsOG0030
T. neutrophils; Week 300; n=30, 37, 43, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00243
ParticipantsOG0030
T. neutrophils; Week 312; n=31, 33, 41, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00241
ParticipantsOG0030
T. neutrophils; Week 324; n=3, 4, 2, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0030
Platelet count; Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Platelet count; Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
Platelet count; Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
Platelet count; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
Platelet count; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
Platelet count; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
Platelet count; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
Platelet count; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
Platelet count; Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
Platelet count; Week 32; n=51, 52, 55, 45
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00255
ParticipantsOG00345
Platelet count; Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
Platelet count; Week 40; n=51, 53, 54, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00345
Platelet count; Week 48; n=51, 52, 53, 44
ParticipantsOG00051
ParticipantsOG00152
ParticipantsOG00253
ParticipantsOG00344
Platelet count; Week 60; n=48, 47, 51, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00251
ParticipantsOG00344
Platelet count; Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
Platelet count; Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
Platelet count; Week 96; n=46, 45, 51, 41
ParticipantsOG00046
ParticipantsOG00145
ParticipantsOG00251
ParticipantsOG00341
Platelet count; Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Platelet count; Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
Platelet count; Week 132; n=40, 46, 48, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG0030
Platelet count; Week 144; n=37, 45, 44, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG0030
Platelet count; Week 156; n=37, 42, 47, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00247
ParticipantsOG0030
Platelet count; Week 168; n=35, 43, 46, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00246
ParticipantsOG0030
Platelet count; Week 180; n=36, 41, 46, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG0030
Platelet count; Week 192; n=35, 40, 46, 0
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG0030
Platelet count; Week 204; n=34, 39, 45, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00245
ParticipantsOG0030
Platelet count; Week 216; n=32, 39, 44, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG0030
Platelet count; Week 228; n=31, 39, 46, 0
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00246
ParticipantsOG0030
Platelet count; Week 240; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
Platelet count; Week 252; n=31, 36, 44, 0
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00244
ParticipantsOG0030
Platelet count; Week 264; n=32, 38, 45, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Platelet count; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
Platelet count; Week 288; n=30, 38, 43, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00243
ParticipantsOG0030
Platelet count; Week 300; n=30, 37, 40, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00240
ParticipantsOG0030
Platelet count; Week 312; n=31, 33, 41, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00241
ParticipantsOG0030
Platelet count; Week 324; n=3, 4, 2, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0030
WBC count; Week 2; n=57, 56, 59, 59
ParticipantsOG00057
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
WBC count; Week 4; n=57, 57, 59, 57
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00259
ParticipantsOG00357
WBC count; Week 8; n=58, 56, 56, 55
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00355
WBC; Week 12; n=58, 53, 57, 51
ParticipantsOG00058
ParticipantsOG00153
ParticipantsOG00257
ParticipantsOG00351
WBC count; Week 16; n=57, 54, 57, 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00257
ParticipantsOG00352
WBC count; Week 20; n=56, 54, 55, 49
ParticipantsOG00056
ParticipantsOG00154
ParticipantsOG00255
ParticipantsOG00349
WBC count; Week 24; n=56, 53, 56, 47
ParticipantsOG00056
ParticipantsOG00153
ParticipantsOG00256
ParticipantsOG00347
WBC count; Week 26; n=48, 50, 53, 45
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00253
ParticipantsOG00345
WBC count; Week 28; n=50, 52, 52, 45
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00252
ParticipantsOG00345
WBC count; Week 32; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
WBC count; Week 36; n=52, 53, 55, 44
ParticipantsOG00052
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00344
WBC count; Week 40; n=51, 53, 55, 45
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00255
ParticipantsOG00345
WBC count; Week 48; n=51, 53, 54, 44
ParticipantsOG00051
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00344
WBC count; Week 60; n=48, 47, 52, 44
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00252
ParticipantsOG00344
WBC count; Week 72; n=47, 48, 52, 42
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00252
ParticipantsOG00342
WBC count; Week 84; n=46, 48, 51, 42
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00342
WBC count; Week 96; n=46, 46, 52, 41
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00252
ParticipantsOG00341
WBC count; Week 108; n=43, 46, 49, 0
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
WBC count; Week 120; n=41, 46, 49, 0
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
WBC count; Week 132; n=40, 46, 49, 0
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00249
ParticipantsOG0030
WBC count; Week 144; n=37, 45, 46, 0
ParticipantsOG00037
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG0030
WBC count; Week 156; n=37, 42, 49, 0
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00249
ParticipantsOG0030
WBC count; Week 168; n=35, 43, 47, 0
ParticipantsOG00035
ParticipantsOG00143
ParticipantsOG00247
ParticipantsOG0030
WBC count; Week 180; n=36, 41, 47, 0
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00247
ParticipantsOG0030
WBC count; Week 192; n=35, 40, 47, 0
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00247
ParticipantsOG0030
WBC count; Week 204; n=34, 39, 47, 0
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
WBC count; Week 216; n=32, 39, 43, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00243
ParticipantsOG0030
WBC count; Week 228; n=31, 39, 47, 0
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
WBC count; Week 240; n=32, 39, 47, 0
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00247
ParticipantsOG0030
WBC count; Week 252; n=31, 36, 45, 0
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00245
ParticipantsOG0030
WBC count; Week 264; n=32, 38, 46, 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
ParticipantsOG0030
WBC count; Week 276; n=31, 38, 45, 0
ParticipantsOG00031
ParticipantsOG00138
ParticipantsOG00245
ParticipantsOG0030
WBC count; Week 288; n=30, 38, 44, 0
ParticipantsOG00030
ParticipantsOG00138
ParticipantsOG00244
ParticipantsOG0030
WBC count; Week 300; n=30, 37, 43, 0
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00243
ParticipantsOG0030
WBC count; Week 312; n=31, 33, 41, 0
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00241
ParticipantsOG0030
WBC count; Week 324; n=3, 4, 2, 0
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0030
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Title
Measurements
OG0007
OG0017
OG0027
OG00315
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Title
Measurements
OG00025
OG00119
OG00215
OG00310
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Any AE
Title
Measurements
OG00054
OG00154
OG00255
OG00359
Any SAE
Title
Measurements
OG0002
OG0010
OG0022
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
ALT; Grade 1
Title
Measurements
OG0003
OG0014
OG00213
OG0038
ALT; Grade 2
Title
Measurements
OG0001
OG0015
OG0020
OG003
ALT; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT; Grade 4
Title
Measurements
OG0000
OG0010
OG0022
OG003
Albumin; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP; Grade 1
Title
Measurements
OG0000
OG0011
OG0024
OG003
ALP; Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALP; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST; Grade 1
Title
Measurements
OG0006
OG0018
OG0027
OG003
AST; Grade 2
Title
Measurements
OG0002
OG0015
OG0021
OG003
AST; Grade 3
Title
Measurements
OG0001
OG0010
OG0023
OG003
AST; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 1
Title
Measurements
OG0001
OG0015
OG0021
OG003
CO2/bicarbonate; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
CO2/bicarbonate; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chloride; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chloride; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chloride; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chloride; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cholesterol; Grade 1
Title
Measurements
OG0007
OG0018
OG00212
OG003
Cholesterol; Grade 2
Title
Measurements
OG0003
OG0012
OG0023
OG003
Cholesterol; Grade 3
Title
Measurements
OG0000
OG0010
OG0022
OG003
Cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
CK; Grade 1
Title
Measurements
OG0007
OG0015
OG0026
OG003
CK; Grade 2
Title
Measurements
OG0002
OG0012
OG0023
OG003
CK; Grade 3
Title
Measurements
OG0003
OG0011
OG0021
OG003
CK; Grade 4
Title
Measurements
OG0002
OG0014
OG0022
OG003
Creatinine; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Creatinine; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose; Grade 1
Title
Measurements
OG00010
OG0018
OG00213
OG003
Glucose; Grade 2
Title
Measurements
OG0005
OG0013
OG0021
OG003
Glucose; Grade 3
Title
Measurements
OG0000
OG0010
OG0022
OG003
Glucose; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
HDL cholesterol; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
HDL cholesterol; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
HDL cholesterol; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
HDL cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
LDL cholesterol; Grade 1
Title
Measurements
OG0005
OG0019
OG0028
OG003
LDL cholesterol; Grade 2
Title
Measurements
OG0004
OG0011
OG0025
OG003
LDL cholesterol; Grade 3
Title
Measurements
OG0000
OG0010
OG0023
OG003
LDL cholesterol; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase; Grade 1
Title
Measurements
OG0009
OG0013
OG0025
OG003
Lipase; Grade 2
Title
Measurements
OG0006
OG0011
OG0027
OG003
Lipase; Grade 3
Title
Measurements
OG0002
OG0011
OG0024
OG003
Lipase; Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
Inorganic phosphorus; Grade 1
Title
Measurements
OG0005
OG0012
OG0027
OG003
Inorganic phosphorus; Grade 2
Title
Measurements
OG0006
OG0012
OG0022
OG003
Inorganic phosphorus; Grade 3
Title
Measurements
OG0001
OG0011
OG0022
OG003
Inorganic phosphorus; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 1
Title
Measurements
OG0007
OG0011
OG0022
OG003
Potassium; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 1
Title
Measurements
OG0007
OG0014
OG0027
OG003
Sodium; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total bilirubin; Grade 1
Title
Measurements
OG0000
OG0011
OG0024
OG003
Total bilirubin; Grade 2
Title
Measurements
OG0002
OG0011
OG0021
OG003
Total bilirubin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total bilirubin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides; Grade 2
Title
Measurements
OG0000
OG0011
OG0023
OG003
Triglycerides; Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Triglycerides; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urea/BUN; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urea/BUN; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urea/BUN; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urea/BUN; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
GSK1265744 30 mg
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
APTT; Grade 1
Title
Measurements
OG0001
OG0010
OG0021
OG0033
APTT; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
APTT; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
APTT; Grade 4
Title
Measurements
OG0000
OG0011
OG0021
OG003
Basophils; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Basophils; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Basophils; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Basophils; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eosinophils; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eosinophils; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eosinophils; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eosinophils; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hemoglobin; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
INR; Grade 1
Title
Measurements
OG0000
OG0012
OG0020
OG003
INR; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
INR; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
INR; Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphocytes; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
MCV; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
MCV; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
MCV; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
MCV; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelet count; Grade 1
Title
Measurements
OG0002
OG0010
OG0022
OG003
Platelet count; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelet count; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelet count; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
PT; Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
PT; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
PT; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
PT; Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
RBC; Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
RBC; Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
RBC; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
RBC; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total neutrophils; Grade 1
Title
Measurements
OG0008
OG0016
OG0028
OG003
Total neutrophils; Grade 2
Title
Measurements
OG0003
OG0012
OG0023
OG003
Total neutrophils; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total neutrophils; Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC count; Grade 1
Title
Measurements
OG0000
OG0012
OG0022
OG003
WBC count; Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
WBC count; Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC count; Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00060
OG00160
OG00261
OG00362
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0025
OG00313
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG003
Efavirenz 600 mg
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Units
Counts
Participants
OG00052
OG00153
OG00255
OG00347
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0022
OG0032
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Units
Counts
Participants
OG00014
OG00112
OG00211
Title
Denominators
Categories
Title
Measurements
OG00045.69± 32
OG001133.74± 32
OG002227.58± 57
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Units
Counts
Participants
OG00014
OG00112
OG00211
Title
Denominators
Categories
Title
Measurements
OG0002.77± 33
OG0017.49± 28
OG00213.12± 44
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Units
Counts
Participants
OG00014
OG00112
OG0029
Title
Denominators
Categories
Title
Measurements
OG0001.45± 37
OG0014.34± 38
OG0025.83± 61
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
GSK1265744 60 mg
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Units
Counts
Participants
OG0000
OG0010
OG0020
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
3 events
3 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0042 events2 affected52 at risk
EG0052 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0083 events2 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0042 events2 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0081 events1 affected46 at risk
EG0094 events3 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0090 events0 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0053 events2 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0053 events2 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0042 events2 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0091 events1 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
8 events
8 affected
62 at risk
EG0047 events5 affected52 at risk
EG0059 events7 affected53 at risk
EG0066 events5 affected55 at risk
EG0075 events5 affected47 at risk
EG0087 events6 affected46 at risk
EG0096 events5 affected47 at risk
EG0105 events5 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0092 events2 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0091 events1 affected47 at risk
EG0103 events3 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0042 events2 affected52 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0053 events3 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0091 events1 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
3 events
3 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0062 events2 affected55 at risk
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EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0093 events2 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
8 events
7 affected
62 at risk
EG0043 events2 affected52 at risk
EG0053 events3 affected53 at risk
EG0062 events2 affected55 at risk
EG0070 events0 affected47 at risk
EG0084 events4 affected46 at risk
EG0094 events3 affected47 at risk
EG0105 events2 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0052 events2 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0052 events2 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
4 events
4 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
15 events
15 affected
62 at risk
EG0041 events1 affected52 at risk
EG0050 events0 affected53 at risk
EG0063 events3 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0103 events3 affected51 at risk
EG0110 events0 affected0 at risk
5 events
4 affected
62 at risk
EG0041 events1 affected52 at risk
EG0051 events1 affected53 at risk
EG0063 events3 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0091 events1 affected47 at risk
EG0106 events6 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0051 events1 affected53 at risk
EG0063 events3 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0046 events5 affected52 at risk
EG0052 events2 affected53 at risk
EG0064 events4 affected55 at risk
EG0074 events4 affected47 at risk
EG0083 events2 affected46 at risk
EG0093 events3 affected47 at risk
EG0103 events3 affected51 at risk
EG0110 events0 affected0 at risk
15 events
14 affected
62 at risk
EG0043 events3 affected52 at risk
EG0052 events2 affected53 at risk
EG0064 events4 affected55 at risk
EG0073 events3 affected47 at risk
EG0083 events3 affected46 at risk
EG0091 events1 affected47 at risk
EG0104 events4 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0042 events2 affected52 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0042 events2 affected52 at risk
EG0051 events1 affected53 at risk
EG0063 events3 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
6 events
6 affected
62 at risk
EG0044 events3 affected52 at risk
EG0053 events3 affected53 at risk
EG0061 events1 affected55 at risk
EG0072 events2 affected47 at risk
EG0081 events1 affected46 at risk
EG0097 events5 affected47 at risk
EG0105 events4 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0042 events2 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
4 events
3 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0062 events2 affected55 at risk
EG0070 events0 affected47 at risk
EG0082 events2 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0043 events3 affected52 at risk
EG0053 events3 affected53 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0097 events6 affected47 at risk
EG0103 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0092 events2 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0053 events2 affected53 at risk
EG0060 events0 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0091 events1 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0062 events2 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0090 events0 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0052 events2 affected53 at risk
EG0063 events3 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0103 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0041 events1 affected52 at risk
EG0052 events1 affected53 at risk
EG0062 events2 affected55 at risk
EG0071 events1 affected47 at risk
EG0082 events2 affected46 at risk
EG0092 events2 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0062 events2 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0052 events2 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0102 events2 affected51 at risk
EG0110 events0 affected0 at risk
3 events
3 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
8 events
8 affected
62 at risk
EG0041 events1 affected52 at risk
EG0057 events6 affected53 at risk
EG0063 events2 affected55 at risk
EG0070 events0 affected47 at risk
EG0081 events1 affected46 at risk
EG0092 events2 affected47 at risk
EG0103 events3 affected51 at risk
EG0110 events0 affected0 at risk
2 events
2 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
5 events
3 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0092 events2 affected47 at risk
EG0101 events1 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0053 events3 affected53 at risk
EG0061 events1 affected55 at risk
EG0071 events1 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
1 events
1 affected
62 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected47 at risk
EG0080 events0 affected46 at risk
EG0090 events0 affected47 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected0 at risk
0 events
0 affected
62 at risk
EG0040 events0 affected52 at risk
EG0053 events3 affected53 at risk
EG0061 events1 affected55 at risk
EG0072 events1 affected47 at risk
EG0081 events1 affected46 at risk
EG0092 events2 affected47 at risk
EG0104 events4 affected51 at risk
EG0110 events0 affected0 at risk
68
68
79
73
81
79
71
73
73
73
73
73
71
68
68
65
0
Title
Measurements
OG00091
OG00186
OG00286
OG00371
Title
Measurements
OG00097
OG00198
OG00297
OG00374
Title
Measurements
OG00095
OG00198
OG00298
OG00391
Title
Measurements
OG00097
OG001100
OG00298
OG00392
Title
Measurements
OG00098
OG001100
OG002100
OG00396
Title
Measurements
OG000100
OG001100
OG002100
OG003100
Title
Measurements
OG000100
OG001100
OG002100
OG003100
Title
Measurements
OG000100
OG001100
OG002100
OG003100
Title
Measurements
OG000100
OG001100
OG002100
OG003100
Title
Measurements
OG000100
OG001100
OG00298
OG003100
Title
Measurements
OG000100
OG001100
OG002100
OG003100
Title
Measurements
OG000100
OG001100
OG002100
OG003100
Title
Measurements
OG00098
OG00198
OG002100
OG003100
Title
Measurements
OG00096
OG001100
OG002100
OG00398
Title
Measurements
OG00098
OG00196
OG002100
OG003100
Title
Measurements
OG000100
OG00198
OG002100
OG003100
Title
Measurements
OG00096
OG001100
OG002100
OG003100
13
24
48
61
74
74
66
69
69
71
68
71
68
68
68
63
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Title
Measurements
OG00051
OG00154
OG00253
OG00314
Title
Measurements
OG00083
OG00182
OG00273
OG00326
Title
Measurements
OG00092
OG00189
OG00293
OG00355
Title
Measurements
OG00095
OG00188
OG00291
OG00376
Title
Measurements
OG00095
OG00194
OG00293
OG00387
Title
Measurements
OG00091
OG00198
OG00298
OG00391
Title
Measurements
OG00093
OG00198
OG00295
OG00396
Title
Measurements
OG00098
OG00194
OG00298
OG00393
Title
Measurements
OG000100
OG00194
OG002100
OG00396
Title
Measurements
OG00096
OG00194
OG00296
OG00396
Title
Measurements
OG00098
OG00196
OG00295
OG00398
Title
Measurements
OG00096
OG00196
OG00295
OG00393
Title
Measurements
OG00092
OG00192
OG00298
OG00398
Title
Measurements
OG00094
OG00196
OG00298
OG00395
Title
Measurements
OG00091
OG00192
OG002100
OG003100
Title
Measurements
OG00091
OG00194
OG002100
OG003100
Title
Measurements
OG00089
OG00198
OG00298
OG00398
Title
Measurements
OG00095
OG00196
OG002100
Title
Measurements
OG00095
OG001100
OG00298
Title
Measurements
OG00095
OG00196
OG002100
Title
Measurements
OG00092
OG00193
OG00298
Title
Measurements
OG00095
OG00195
OG00298
Title
Measurements
OG00094
OG00195
OG00298
Title
Measurements
OG00097
OG001100
OG00298
Title
Measurements
OG00094
OG001100
OG00296
Title
Measurements
OG00097
OG00197
OG00298
Title
Measurements
OG000100
OG001100
OG00298
Title
Measurements
OG000100
OG001100
OG00298
Title
Measurements
OG00097
OG00197
OG002100
Title
Measurements
OG000100
OG00197
OG00298
Title
Measurements
OG000100
OG001100
OG00298
Title
Measurements
OG000100
OG001100
OG00296
Title
Measurements
OG000100
OG001100
OG002100
Title
Measurements
OG00097
OG001100
OG00295
Title
Measurements
OG000100
OG00197
OG002100
Title
Measurements
OG000100
OG001100
OG002100
4.290
± 0.6683
Title
Measurements
OG0001.883± 0.4551
OG0011.984± 0.5786
OG0021.939± 0.5071
OG0032.415± 0.5717
Title
Measurements
OG0001.706± 0.3245
OG0011.731± 0.4141
OG0021.725± 0.2750
OG0032.201± 0.5780
Title
Measurements
OG0001.695± 0.4114
OG0011.666± 0.3676
OG0021.666± 0.3926
OG0031.950± 0.5636
Title
Measurements
OG0001.643± 0.2506
OG0011.618± 0.0786
OG0021.641± 0.2033
OG0031.758± 0.4082
Title
Measurements
OG0001.619± 0.1418
OG0011.602± 0.0354
OG0021.616± 0.0956
OG0031.697± 0.3277
Title
Measurements
OG0001.623± 0.1175
OG0011.596± 0.0346
OG0021.599± 0.0591
OG0031.649± 0.1962
Title
Measurements
OG0001.615± 0.1010
OG0011.597± 0.0360
OG0021.603± 0.0532
OG0031.610± 0.0902
Title
Measurements
OG0001.595± 0.0270
OG0011.602± 0.0434
OG0021.594± 0.0194
OG0031.610± 0.0742
Title
Measurements
OG0001.591± 0.0000
OG0011.607± 0.0565
OG0021.591± 0.0000
OG0031.600± 0.0451
Title
Measurements
OG0001.609± 0.0955
OG0011.620± 0.1277
OG0021.618± 0.1742
OG0031.614± 0.1022
Title
Measurements
OG0001.604± 0.0782
OG0011.610± 0.1070
OG0021.606± 0.0722
OG0031.607± 0.1068
Title
Measurements
OG0001.612± 0.1206
OG0011.618± 0.1214
OG0021.608± 0.0752
OG0031.607± 0.0650
Title
Measurements
OG0001.686± 0.4077
OG0011.654± 0.3673
OG0021.598± 0.0508
OG0031.596± 0.0247
Title
Measurements
OG0001.648± 0.2643
OG0011.598± 0.0300
OG0021.594± 0.0205
OG0031.657± 0.3948
Title
Measurements
OG0001.625± 0.1584
OG0011.697± 0.4705
OG0021.591± 0.0000
OG0031.592± 0.0065
Title
Measurements
OG0001.645± 0.1838
OG0011.643± 0.2896
OG0021.592± 0.0059
OG0031.591± 0.0017
Title
Measurements
OG0001.681± 0.2783
OG0011.603± 0.0861
OG0021.596± 0.0227
OG0031.598± 0.0467
Title
Measurements
OG0001.634± 0.1979
OG0011.609± 0.0885
OG0021.591± 0.0000
Title
Measurements
OG0001.638± 0.2216
OG0011.591± 0.0000
OG0021.618± 0.1884
Title
Measurements
OG0001.646± 0.2491
OG0011.631± 0.2097
OG0021.591± 0.0000
Title
Measurements
OG0001.682± 0.4027
OG0011.698± 0.5940
OG0021.630± 0.2656
Title
Measurements
OG0001.634± 0.1850
OG0011.603± 0.0520
OG0021.619± 0.1833
Title
Measurements
OG0001.665± 0.3351
OG0011.642± 0.2908
OG0021.603± 0.0810
Title
Measurements
OG0001.613± 0.1324
OG0011.591± 0.0000
OG0021.600± 0.0584
Title
Measurements
OG0001.689± 0.4119
OG0011.591± 0.0000
OG0021.699± 0.6971
Title
Measurements
OG0001.628± 0.2162
OG0011.595± 0.0252
OG0021.634± 0.2936
Title
Measurements
OG0001.591± 0.0000
OG0011.592± 0.0052
OG0021.634± 0.2948
Title
Measurements
OG0001.591± 0.0000
OG0011.591± 0.0000
OG0021.625± 0.2351
Title
Measurements
OG0001.596± 0.0268
OG0011.601± 0.0465
OG0021.591± 0.0000
Title
Measurements
OG0001.591± 0.0000
OG0011.599± 0.0461
OG0021.593± 0.0157
Title
Measurements
OG0001.591± 0.0000
OG0011.591± 0.0000
OG0021.617± 0.1788
Title
Measurements
OG0001.591± 0.0000
OG0011.591± 0.0000
OG0021.618± 0.1398
Title
Measurements
OG0001.591± 0.000
OG0011.592± 0.0052
OG0021.591± 0.0000
Title
Measurements
OG0001.601± 0.0551
OG0011.591± 0.0000
OG0021.625± 0.1753
Title
Measurements
OG0001.597± 0.0214
OG0011.600± 0.0494
OG0021.591± 0.0000
Title
Measurements
OG0001.591± 0.0000
OG0011.591± 0.0000
OG0021.591± 0.0000
-1.875
± 0.4273
Title
Measurements
OG000-2.731± 0.4158
OG001-2.550± 0.6300
OG002-2.718± 0.4981
OG003-2.092± 0.4866
Title
Measurements
OG000-2.733± 0.6374
OG001-2.611± 0.6938
OG002-2.741± 0.7034
OG003-2.344± 0.6765
Title
Measurements
OG000-2.793± 0.5574
OG001-2.634± 0.6308
OG002-2.790± 0.6515
OG003-2.533± 0.6580
Title
Measurements
OG000-2.823± 0.5118
OG001-2.659± 0.6363
OG002-2.815± 0.6170
OG003-2.602± 0.6698
Title
Measurements
OG000-2.823± 0.5329
OG001-2.665± 0.6418
OG002-2.834± 0.6250
OG003-2.666± 0.6512
Title
Measurements
OG000-2.831± 0.5465
OG001-2.659± 0.6488
OG002-2.830± 0.6304
OG003-2.694± 0.6843
Title
Measurements
OG000-2.788± 0.5023
OG001-2.662± 0.6670
OG002-2.792± 0.6014
OG003-2.733± 0.6879
Title
Measurements
OG000-2.784± 0.4944
OG001-2.663± 0.6356
OG002-2.791± 0.5831
OG003-2.714± 0.6873
Title
Measurements
OG000-2.763± 0.5164
OG001-2.636± 0.6598
OG002-2.781± 0.6146
OG003-2.672± 0.6812
Title
Measurements
OG000-2.768± 0.5000
OG001-2.646± 0.6786
OG002-2.792± 0.5803
OG003-2.679± 0.6776
Title
Measurements
OG000-2.760± 0.5143
OG001-2.638± 0.6581
OG002-2.790± 0.5736
OG003-2.679± 0.6817
Title
Measurements
OG000-2.682± 0.6637
OG001-2.602± 0.7855
OG002-2.799± 0.5946
OG003-2.676± 0.6773
Title
Measurements
OG000-2.729± 0.6405
OG001-2.613± 0.6068
OG002-2.787± 0.5920
OG003-2.615± 0.8875
Title
Measurements
OG000-2.745± 0.5229
OG001-2.514± 0.7487
OG002-2.783± 0.6009
OG003-2.738± 0.6415
Title
Measurements
OG000-2.722± 0.5650
OG001-2.568± 0.7144
OG002-2.782± 0.5994
OG003-2.739± 0.6431
Title
Measurements
OG000-2.670± 0.5277
OG001-2.608± 0.6342
OG002-2.778± 0.5943
OG003-2.731± 0.6586
Title
Measurements
OG000-2.723± 0.5396
OG001-2.632± 0.6265
OG002-2.743± 0.5851
Title
Measurements
OG000-2.712± 0.5477
OG001-2.650± 0.6137
OG002-2.717± 0.6180
Title
Measurements
OG000-2.705± 0.5504
OG001-2.610± 0.6718
OG002-2.743± 0.5851
Title
Measurements
OG000-2.690± 0.6615
OG001-2.555± 0.9008
OG002-2.703± 0.6903
Title
Measurements
OG000-2.737± 0.5476
OG001-2.645± 0.6129
OG002-2.716± 0.6309
Title
Measurements
OG000-2.680± 0.6170
OG001-2.592± 0.7138
OG002-2.700± 0.5907
Title
Measurements
OG000-2.747± 0.4984
OG001-2.628± 0.6251
OG002-2.767± 0.5672
Title
Measurements
OG000-2.671± 0.6656
OG001-2.641± 0.6272
OG002-2.667± 0.8708
Title
Measurements
OG000-2.750± 0.5359
OG001-2.632± 0.6353
OG002-2.718± 0.7294
Title
Measurements
OG000-2.787± 0.4956
OG001-2.636± 0.6337
OG002-2.718± 0.6660
Title
Measurements
OG000-2.770± 0.4940
OG001-2.636± 0.6346
OG002-2.726± 0.6757
Title
Measurements
OG000-2.798± 0.4923
OG001-2.627± 0.6181
OG002-2.736± 0.5861
Title
Measurements
OG000-2.787± 0.5092
OG001-2.601± 0.6209
OG002-2.758± 0.5875
Title
Measurements
OG000-2.780± 0.5022
OG001-2.659± 0.6264
OG002-2.734± 0.6213
Title
Measurements
OG000-2.786± 0.5095
OG001-2.659± 0.6264
OG002-2.764± 0.6002
Title
Measurements
OG000-2.768± 0.5083
OG001-2.659± 0.6246
OG002-2.775± 0.5984
Title
Measurements
OG000-2.776± 0.5062
OG001-2.664± 0.6344
OG002-2.730± 0.6786
Title
Measurements
OG000-2.780± 0.5085
OG001-2.569± 0.6037
OG002-2.789± 0.5825
Title
Measurements
OG000-2.488± 0.1409
OG001-2.215± 0.4624
OG002-2.438± 0.5904
0
0
0
456.5
± 196.11
Title
Measurements
OG000544.0± 197.54
OG001525.1± 181.29
OG002549.3± 206.68
OG003487.0± 222.84
Title
Measurements
OG000580.5± 230.40
OG001522.0± 205.80
OG002545.8± 196.79
OG003509.9± 198.21
Title
Measurements
OG000576.6± 196.55
OG001555.2± 210.92
OG002544.3± 176.01
OG003531.4± 175.95
Title
Measurements
OG000588.4± 208.15
OG001599.0± 226.06
OG002596.6± 181.00
OG003564.3± 222.99
Title
Measurements
OG000608.3± 200.34
OG001595.8± 197.47
OG002599.7± 166.77
OG003594.4± 212.63
Title
Measurements
OG000607.3± 204.87
OG001607.4± 199.27
OG002636.6± 225.04
OG003607.7± 186.36
Title
Measurements
OG000614.6± 194.13
OG001626.5± 210.63
OG002658.0± 253.19
OG003599.5± 219.52
Title
Measurements
OG000632.8± 210.93
OG001629.5± 207.34
OG002645.8± 188.61
OG003625.7± 196.46
Title
Measurements
OG000652.2± 225.32
OG001635.9± 217.52
OG002653.3± 261.11
OG003635.7± 224.72
Title
Measurements
OG000638.1± 192.54
OG001650.8± 209.66
OG002665.2± 246.84
OG003663.8± 257.25
Title
Measurements
OG000638.7± 198.05
OG001658.6± 226.51
OG002720.3± 257.85
OG003651.5± 212.15
Title
Measurements
OG000650.2± 218.40
OG001658.5± 204.08
OG002667.6± 187.30
OG003687.9± 241.35
Title
Measurements
OG000677.3± 219.75
OG001687.2± 227.06
OG002713.8± 215.70
OG003732.6± 273.19
Title
Measurements
OG000668.1± 222.61
OG001720.9± 268.74
OG002719.8± 219.04
OG003733.9± 238.90
Title
Measurements
OG000683.2± 242.75
OG001651.3± 217.19
OG002710.9± 259.89
OG003722.5± 263.47
Title
Measurements
OG000718.3± 212.59
OG001736.9± 271.85
OG002735.0± 236.25
OG003744.7± 250.90
Title
Measurements
OG000726.2± 272.28
OG001722.9± 246.22
OG002743.1± 242.23
OG003747.8± 263.27
24.8
± 138.47
Title
Measurements
OG000136.4± 157.36
OG00176.9± 107.01
OG00288.2± 110.01
OG00346.0± 106.35
Title
Measurements
OG000129.9± 123.47
OG001117.8± 132.19
OG00290.5± 148.25
OG00365.6± 120.25
Title
Measurements
OG000140.5± 142.86
OG001140.8± 165.02
OG002145.2± 142.24
OG003103.4± 125.39
Title
Measurements
OG000159.3± 115.36
OG001142.2± 145.64
OG002148.3± 131.81
OG003135.5± 153.48
Title
Measurements
OG000165.2± 146.90
OG001153.8± 150.40
OG002182.6± 142.18
OG003149.0± 117.44
Title
Measurements
OG000172.5± 112.04
OG001180.9± 161.43
OG002204.0± 166.78
OG003143.4± 145.18
Title
Measurements
OG000186.4± 153.99
OG001177.7± 146.84
OG002194.7± 149.66
OG003166.4± 145.11
Title
Measurements
OG000205.0± 164.91
OG001188.1± 132.08
OG002193.3± 154.43
OG003178.2± 150.25
Title
Measurements
OG000191.4± 151.79
OG001205.2± 145.53
OG002209.9± 157.56
OG003197.4± 170.48
Title
Measurements
OG000192.0± 165.97
OG001213.0± 144.89
OG002265.0± 169.42
OG003185.2± 152.91
Title
Measurements
OG000203.6± 171.74
OG001212.8± 180.38
OG002212.3± 114.67
OG003221.5± 188.99
Title
Measurements
OG000235.1± 179.89
OG001241.6± 182.90
OG002259.0± 154.21
OG003262.5± 201.33
Title
Measurements
OG000217.7± 152.92
OG001269.4± 188.34
OG002266.1± 156.03
OG003263.8± 181.15
Title
Measurements
OG000232.0± 191.05
OG001201.4± 206.54
OG002254.0± 189.26
OG003257.1± 216.41
Title
Measurements
OG000261.5± 171.65
OG001287.0± 207.10
OG002278.1± 166.11
OG003279.4± 191.30
Title
Measurements
OG000269.4± 204.32
OG001267.5± 196.27
OG002286.2± 181.50
OG003281.7± 232.90
Title
Measurements
OG000296.2± 215.21
OG001304.3± 195.30
OG002288.4± 184.61
Title
Measurements
OG000266.1± 173.09
OG001279.3± 181.10
OG002307.2± 225.39
Title
Measurements
OG000297.1± 167.59
OG001305.2± 184.98
OG002313.2± 168.30
Title
Measurements
OG000330.7± 225.42
OG001308.9± 224.63
OG002322.4± 224.57
Title
Measurements
OG000334.5± 213.79
OG001319.2± 182.15
OG002320.4± 187.58
Title
Measurements
OG000338.1± 252.13
OG001332.4± 222.37
OG002361.3± 198.98
Title
Measurements
OG000338.0± 218.72
OG001348.6± 203.73
OG002384.2± 192.86
Title
Measurements
OG000300.8± 168.24
OG001351.0± 205.56
OG002342.3± 204.83
Title
Measurements
OG000369.5± 196.17
OG001332.9± 179.28
OG002340.0± 191.82
Title
Measurements
OG000397.0± 202.03
OG001373.4± 188.28
OG002357.8± 199.87
Title
Measurements
OG000331.8± 168.64
OG001366.5± 231.25
OG002383.7± 253.17
Title
Measurements
OG000356.5± 195.99
OG001395.9± 205.55
OG002408.4± 201.05
Title
Measurements
OG000400.3± 183.36
OG001343.7± 196.09
OG002383.1± 217.20
Title
Measurements
OG000344.4± 160.38
OG001365.0± 210.00
OG002391.8± 222.00
Title
Measurements
OG000398.3± 250.45
OG001350.3± 210.98
OG002362.2± 243.30
Title
Measurements
OG000411.0± 161.93
OG001383.5± 279.75
OG002337.1± 187.13
Title
Measurements
OG000437.7± 196.33
OG001404.4± 239.11
OG002353.5± 200.23
Title
Measurements
OG000335.0± 176.73
OG001433.0± 264.63
OG002407.0± 178.06
Title
Measurements
OG000402.0± 197.55
OG001276.0± 278.28
OG002272.0± 277.44
0
Title
Measurements
OG0003
OG0011
OG0021
OG0032
Title
Measurements
OG0003
OG0010
OG0021
OG0030
Title
Measurements
OG0002
OG0011
OG0021
OG0032
Title
Measurements
OG0003
OG0010
OG0020
OG0030
Title
Measurements
OG0003
OG0012
OG0022
OG0035
Title
Measurements
OG0003
OG0010
OG0020
OG0030
Title
Measurements
OG0003
OG0012
OG0022
OG0035
Title
Measurements
OG0003
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0003
OG0012
OG0022
OG0035
Title
Measurements
OG0003
OG0010
OG0020
OG0030
Title
Measurements
OG0003
OG0012
OG0022
OG0035
Title
Measurements
OG0003
OG0010
OG0020
OG0030
Title
Measurements
OG0003
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Title
Measurements
OG0005
OG0012
OG0022
OG0035
Title
Measurements
OG0002
OG0010
OG0020
OG0030
Title
Measurements
OG0004
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Title
Measurements
OG0006
OG0012
OG0022
OG0035
0
48
Title
Measurements
OG00046
OG00149
OG00252
OG00344
Title
Measurements
OG00049
OG00145
OG00253
OG00347
Title
Measurements
OG00044
OG00140
OG00246
OG00343
Title
Measurements
OG00044
OG00145
OG00250
OG00342
Title
Measurements
OG00045
OG00140
OG00251
OG00341
Title
Measurements
OG00047
OG00141
OG00248
OG00339
Title
Measurements
OG00045
OG00146
OG00248
OG00335
Title
Measurements
OG00046
OG00142
OG00252
OG00337
Title
Measurements
OG00040
OG00143
OG00248
OG00336
Title
Measurements
OG00033
OG00130
OG00241
OG00334
Title
Measurements
OG00032
OG00133
OG00241
OG00333
Title
Measurements
OG00037
OG00135
OG00237
OG00335
Title
Measurements
OG00032
OG00135
OG00241
OG00327
Title
Measurements
OG00034
OG00136
OG00239
OG00329
Title
Measurements
OG00025
OG00132
OG00230
Title
Measurements
OG00021
OG00120
OG00227
Title
Measurements
OG00028
OG00136
OG00239
Title
Measurements
OG00028
OG00130
OG00235
Title
Measurements
OG00032
OG00129
OG00241
Title
Measurements
OG00030
OG00125
OG00235
Title
Measurements
OG00029
OG00124
OG00235
Title
Measurements
OG00024
OG00124
OG00234
Title
Measurements
OG00028
OG00127
OG00235
Title
Measurements
OG00027
OG00126
OG00233
Title
Measurements
OG00029
OG00127
OG00231
Title
Measurements
OG00025
OG00128
OG00235
Title
Measurements
OG00028
OG00122
OG00235
Title
Measurements
OG00018
OG00121
OG00229
Title
Measurements
OG00012
OG00116
OG00221
Title
Measurements
OG00013
OG00113
OG00218
Title
Measurements
OG00012
OG00110
OG00217
Title
Measurements
OG00011
OG0017
OG00218
Title
Measurements
OG0001
OG0011
74
(63 to 85)
87
91
91
94
89
94
89
89
89
83
2
3
0
1
0
0
0
0
4
0
0
0
5
2
3
2
8
1
0
0
9
10
4
0
5
0
3
5
1
0
0
0
11
5
0
0
8
6
4
0
9
7
0
0
7
9
2
0
4
1
0
0
7
1
0
0
0
0
0
0
0
1
1
0
0
0
1
0
0
0
0
3
1
0
0
1
0
0
0
3
1
0
0
2
3
1
1
3
0
0
0
4
4
0
1
0
0
0
0
5
0
0
0
7
2
3
2
8
1
0
0
9
10
6
0
5
0
4
5
1
1
0
0
12
6
0
1
8
7
4
0
10
7
1
0
8
9
2
0
4
1
0
0
11
1
0
0
0
0
0
0
0
1
1
1
0
0
1
0
0
0
0
3
1
0
0
1
0
0
0
3
1
0
0
2
3
1
1
3
0
0
0
30.5
± 29.21
Title
Measurements
OG00024.0± 13.29
OG00126.3± 17.81
OG00227.2± 14.49
OG00330.0± 26.73
Title
Measurements
OG00023.1± 14.31
OG00125.6± 17.29
OG00230.3± 24.25
OG00331.4± 27.43
Title
Measurements
OG00025.4± 16.06
OG00129.3± 23.15
OG00235.9± 63.11
OG00325.0± 13.21
Title
Measurements
OG00025.0± 15.37
OG00131.4± 28.65
OG00226.6± 16.27
OG00325.7± 17.44
Title
Measurements
OG00026.0± 25.88
OG00128.5± 27.79
OG00226.9± 18.68
OG00330.4± 22.55
Title
Measurements
OG00022.3± 11.62
OG00124.9± 15.72
OG00230.3± 24.34
OG00327.0± 15.71
Title
Measurements
OG00020.9± 9.86
OG00127.5± 23.90
OG00228.6± 19.62
OG00325.7± 13.31
Title
Measurements
OG00024.2± 16.54
OG00126.6± 26.63
OG00223.5± 10.77
OG00328.3± 25.23
Title
Measurements
OG00020.4± 11.47
OG00126.5± 26.66
OG00224.8± 14.94
OG00324.2± 13.67
Title
Measurements
OG00019.5± 9.83
OG00126.9± 27.66
OG00223.2± 14.67
OG00323.1± 10.19
Title
Measurements
OG00023.4± 26.79
OG00124.7± 17.44
OG00224.2± 15.60
OG00323.5± 10.53
Title
Measurements
OG00022.7± 18.13
OG00124.6± 15.43
OG00225.8± 23.50
OG00323.4± 10.92
Title
Measurements
OG00018.4± 8.32
OG00124.8± 15.91
OG00224.8± 19.60
OG00322.6± 10.92
Title
Measurements
OG00021.4± 17.70
OG00125.9± 16.69
OG00228.1± 26.70
OG00324.9± 13.59
Title
Measurements
OG00019.9± 9.98
OG00130.7± 28.68
OG00226.3± 20.29
OG00322.7± 9.62
Title
Measurements
OG00020.1± 11.56
OG00129.9± 20.77
OG00225.3± 19.53
OG00327.1± 32.55
Title
Measurements
OG00022.0± 18.20
OG00148.7± 153.96
OG00225.5± 21.23
OG00324.3± 22.84
Title
Measurements
OG00025.0± 7.36
OG00127.5± 11.15
OG00228.1± 12.01
OG00331.5± 28.43
Title
Measurements
OG00025.6± 8.36
OG00126.6± 11.38
OG00226.8± 8.60
OG00332.8± 51.17
Title
Measurements
OG00024.0± 7.95
OG00125.0± 11.37
OG00228.3± 16.29
OG00329.0± 15.61
Title
Measurements
OG00028.7± 31.34
OG00129.5± 23.47
OG00232.8± 37.43
OG00324.4± 5.73
Title
Measurements
OG00026.3± 13.40
OG00129.0± 24.56
OG00225.5± 8.05
OG00324.4± 9.49
Title
Measurements
OG00024.2± 12.70
OG00129.2± 24.00
OG00226.5± 9.42
OG00336.7± 71.83
Title
Measurements
OG00026.0± 20.71
OG00124.2± 10.38
OG00231.7± 26.31
OG00328.7± 28.75
Title
Measurements
OG00023.3± 8.93
OG00127.2± 17.43
OG00228.6± 14.12
OG00326.1± 9.61
Title
Measurements
OG00028.4± 28.28
OG00126.9± 18.86
OG00224.5± 6.64
OG00325.8± 12.21
Title
Measurements
OG00022.6± 8.77
OG00126.7± 16.58
OG00225.5± 11.24
OG00323.7± 7.89
Title
Measurements
OG00021.9± 7.74
OG00126.5± 19.14
OG00225.6± 9.19
OG00325.4± 12.33
Title
Measurements
OG00029.2± 39.15
OG00125.4± 12.50
OG00226.4± 11.38
OG00326.3± 13.66
Title
Measurements
OG00024.7± 14.04
OG00124.5± 10.35
OG00226.5± 14.21
OG00323.0± 6.17
Title
Measurements
OG00021.4± 8.02
OG00124.3± 12.32
OG00224.2± 9.26
OG00323.7± 8.45
Title
Measurements
OG00023.4± 10.41
OG00125.3± 12.77
OG00230.4± 21.00
OG00324.9± 8.31
Title
Measurements
OG00021.8± 7.67
OG00131.0± 22.80
OG00226.4± 10.52
OG00322.9± 6.28
Title
Measurements
OG00022.3± 8.10
OG00129.2± 16.93
OG00225.2± 9.11
OG00329.9± 37.33
Title
Measurements
OG00023.6± 22.38
OG00147.7± 150.51
OG00225.9± 12.90
OG00327.7± 35.71
Title
Measurements
OG000197.3± 178.83
OG001295.9± 604.02
OG002181.2± 217.99
OG003349.8± 1521.09
Title
Measurements
OG000237.9± 271.07
OG001276.1± 468.74
OG002184.8± 143.83
OG003512.1± 2788.37
Title
Measurements
OG000196.7± 159.74
OG001221.8± 426.95
OG002180.5± 174.80
OG003236.2± 563.36
Title
Measurements
OG000413.3± 1523.18
OG001427.2± 1518.27
OG002451.7± 1788.60
OG003152.9± 94.19
Title
Measurements
OG000316.1± 570.21
OG001314.7± 1116.09
OG002211.8± 174.07
OG003161.2± 163.26
Title
Measurements
OG000195.1± 180.51
OG001427.3± 1339.99
OG002213.3± 190.94
OG003646.5± 3471.23
Title
Measurements
OG000342.7± 953.66
OG001202.1± 309.41
OG002485.3± 1835.11
OG003528.2± 2643.29
Title
Measurements
OG000226.0± 230.13
OG001306.3± 690.18
OG002243.0± 228.95
OG003247.4± 498.72
Title
Measurements
OG000344.1± 606.10
OG001267.7± 516.53
OG002242.5± 275.72
OG003163.5± 156.79
Title
Measurements
OG000213.4± 182.12
OG001276.8± 581.44
OG002290.4± 457.59
OG003154.7± 168.77
Title
Measurements
OG000205.6± 171.74
OG001248.8± 525.79
OG002311.3± 437.31
OG003254.7± 778.33
Title
Measurements
OG000528.4± 1984.77
OG001242.9± 353.65
OG002255.2± 275.74
OG003303.1± 615.91
Title
Measurements
OG000259.5± 381.33
OG001225.4± 342.50
OG002292.6± 360.32
OG003150.2± 96.11
Title
Measurements
OG000203.5± 136.48
OG001219.3± 527.75
OG002219.8± 195.62
OG003146.3± 88.07
Title
Measurements
OG000315.7± 730.27
OG001215.5± 340.37
OG002399.6± 923.74
OG003168.0± 154.36
Title
Measurements
OG000182.5± 148.31
OG001354.0± 911.76
OG002247.7± 348.72
OG003120.5± 59.89
Title
Measurements
OG000204.3± 160.30
OG001329.2± 724.97
OG002195.0± 164.14
OG003258.6± 650.38
Title
Measurements
OG000542.7± 2451.57
OG001272.8± 589.15
OG002199.7± 194.46
OG003281.1± 903.71
83.1
± 13.41
Title
Measurements
OG00083.8± 14.33
OG00183.3± 14.10
OG00284.6± 15.27
OG00383.8± 15.29
Title
Measurements
OG00082.9± 15.45
OG00183.0± 14.55
OG00284.2± 14.28
OG00383.1± 14.22
Title
Measurements
OG00082.9± 13.79
OG00182.2± 13.03
OG00283.5± 14.41
OG00382.4± 13.94
Title
Measurements
OG00083.8± 13.33
OG00182.7± 14.96
OG00284.1± 14.64
OG00381.1± 12.83
Title
Measurements
OG00083.4± 17.07
OG00182.3± 14.56
OG00282.4± 14.16
OG00379.6± 11.83
Title
Measurements
OG00083.2± 12.95
OG00182.0± 14.42
OG00286.1± 14.34
OG00379.5± 11.72
Title
Measurements
OG00083.2± 13.07
OG00183.3± 15.56
OG00285.2± 13.93
OG00380.0± 20.74
Title
Measurements
OG00083.4± 13.45
OG00182.6± 14.15
OG00287.0± 13.82
OG00378.6± 9.61
Title
Measurements
OG00083.0± 13.32
OG00183.8± 14.84
OG00285.6± 13.96
OG00378.5± 10.34
Title
Measurements
OG00083.8± 14.11
OG00182.6± 13.48
OG00285.7± 14.34
OG00378.1± 9.90
Title
Measurements
OG00083.5± 12.68
OG00184.6± 13.22
OG00286.7± 16.21
OG00378.4± 10.87
Title
Measurements
OG00083.3± 12.60
OG00183.2± 13.04
OG00285.4± 14.38
OG00379.2± 15.99
Title
Measurements
OG00083.4± 13.48
OG00183.1± 14.55
OG00285.0± 14.54
OG00379.0± 12.52
Title
Measurements
OG00083.9± 13.85
OG00183.0± 14.31
OG00285.2± 14.57
OG00377.9± 11.13
Title
Measurements
OG00084.5± 12.46
OG00186.1± 14.95
OG00287.3± 14.95
OG00377.7± 11.44
Title
Measurements
OG00085.0± 15.06
OG00184.8± 17.41
OG00287.3± 13.15
OG00379.7± 11.20
Title
Measurements
OG00082.0± 11.46
OG00186.4± 17.24
OG00288.5± 14.75
OG00381.0± 10.10
Title
Measurements
OG0009.2± 4.65
OG0019.4± 4.59
OG00210.5± 5.48
OG0039.7± 4.42
Title
Measurements
OG0009.2± 4.48
OG0019.1± 4.50
OG00210.0± 5.92
OG0036.8± 1.71
Title
Measurements
OG0009.4± 4.40
OG0019.3± 4.47
OG0029.8± 6.05
OG0036.4± 1.61
Title
Measurements
OG0009.3± 4.50
OG0019.0± 3.33
OG00210.1± 5.55
OG0036.3± 1.46
Title
Measurements
OG0009.5± 5.16
OG0018.9± 3.79
OG00210.2± 5.47
OG0037.0± 2.57
Title
Measurements
OG0009.6± 5.04
OG0018.5± 3.90
OG00210.4± 4.88
OG0037.0± 2.61
Title
Measurements
OG0009.0± 4.09
OG0019.0± 4.91
OG00210.4± 5.49
OG0036.8± 1.67
Title
Measurements
OG0009.6± 5.18
OG0019.8± 5.09
OG00210.0± 4.52
OG0036.6± 1.60
Title
Measurements
OG00010.6± 4.97
OG0019.9± 5.83
OG00212.0± 5.11
OG0036.8± 2.19
Title
Measurements
OG00010.3± 4.87
OG00110.2± 5.90
OG00211.4± 4.77
OG0036.4± 1.51
Title
Measurements
OG0009.8± 4.91
OG0019.8± 4.80
OG00211.7± 6.70
OG0036.6± 1.74
Title
Measurements
OG00010.3± 5.25
OG00110.1± 5.47
OG00212.2± 6.08
OG0036.5± 1.71
Title
Measurements
OG00010.8± 5.81
OG00111.2± 7.04
OG00212.3± 6.67
OG0036.3± 1.53
Title
Measurements
OG00010.0± 4.96
OG0019.6± 3.86
OG00210.4± 4.91
OG0036.6± 1.65
Title
Measurements
OG00011.2± 4.28
OG0019.8± 3.75
OG00211.6± 6.28
OG0037.0± 2.13
Title
Measurements
OG00010.8± 6.63
OG00110.0± 4.89
OG00211.4± 5.87
OG0036.5± 1.40
Title
Measurements
OG00011.7± 6.77
OG0019.9± 4.35
OG00212.0± 5.64
OG0036.6± 2.27
Title
Measurements
OG00010.3± 5.29
OG0019.9± 4.58
OG00212.5± 5.61
OG0036.8± 1.80
125.6
± 35.30
Title
Measurements
OG00096.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG001106.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG00399.0± 31.00
Title
Measurements
OG000129.3± 31.29
OG001132.5± 42.28
OG002122.4± 33.00
OG003127.0± 35.64
Title
Measurements
OG000125.0± 35.36
OG001124.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG002143.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG003101.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG000132.4± 50.97
OG001139.4± 42.30
OG002123.9± 31.85
OG003132.3± 39.97
Title
Measurements
OG000137.0± 11.31
OG003122.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG000127.9± 30.90
OG001132.8± 39.93
OG002120.7± 27.41
OG003135.1± 38.98
Title
Measurements
OG001147.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG001180.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG000127.0± 30.01
OG001139.2± 42.07
OG002122.3± 29.21
OG003131.0± 44.41
Title
Measurements
OG003144.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG000130.8± 40.80
OG001137.7± 45.07
OG002116.6± 27.05
OG003134.8± 43.35
145.4
± 12.39
Title
Measurements
OG000142.0± 13.84
OG001142.8± 11.68
OG002145.9± 12.05
OG003146.4± 13.49
Title
Measurements
OG000141.9± 13.39
OG001143.5± 11.69
OG002147.3± 12.13
OG003146.6± 13.06
Title
Measurements
OG000144.9± 13.10
OG001147.7± 11.88
OG002148.6± 12.10
OG003148.1± 12.32
Title
Measurements
OG000144.3± 12.19
OG001147.4± 10.60
OG002149.1± 11.25
OG003149.2± 13.14
Title
Measurements
OG000143.5± 11.77
OG001146.5± 10.71
OG002148.7± 11.08
OG003147.6± 12.05
Title
Measurements
OG000144.3± 13.33
OG001146.9± 11.23
OG002149.8± 11.11
OG003147.2± 12.18
Title
Measurements
OG000144.8± 12.66
OG001147.8± 10.69
OG002150.4± 11.65
OG003148.5± 11.31
Title
Measurements
OG000144.4± 13.30
OG001145.8± 11.63
OG002149.8± 11.47
OG003148.2± 12.32
Title
Measurements
OG000143.7± 13.20
OG001146.8± 10.89
OG002149.3± 10.15
OG003145.9± 13.17
Title
Measurements
OG000144.6± 9.53
OG001146.1± 10.44
OG002150.5± 11.19
OG003145.9± 11.41
Title
Measurements
OG000142.3± 11.07
OG001145.9± 11.24
OG002149.8± 11.26
OG003145.0± 10.73
Title
Measurements
OG000142.2± 11.06
OG001145.2± 11.03
OG002149.2± 11.71
OG003145.1± 9.98
Title
Measurements
OG000142.9± 9.15
OG001145.7± 10.59
OG002146.5± 12.48
OG003145.4± 12.24
Title
Measurements
OG000144.5± 9.91
OG001148.3± 10.96
OG002149.8± 10.82
OG003147.6± 12.73
Title
Measurements
OG000143.9± 10.24
OG001148.1± 10.15
OG002149.6± 11.46
OG003147.7± 11.22
Title
Measurements
OG000145.6± 11.00
OG001147.7± 10.04
OG002150.3± 10.38
OG003147.0± 11.77
Title
Measurements
OG000144.9± 12.41
OG001147.1± 11.06
OG002150.8± 10.37
OG003147.0± 11.03
2.441
± 1.1548
Title
Measurements
OG0002.723± 1.1402
OG0012.776± 1.0729
OG0022.598± 1.1295
OG0033.207± 1.6307
Title
Measurements
OG0002.685± 1.2477
OG0012.771± 1.2587
OG0022.649± 1.0692
OG0032.848± 1.8642
Title
Measurements
OG0002.899± 1.2111
OG0012.802± 1.1296
OG0022.738± 1.1533
OG0032.746± 0.9969
Title
Measurements
OG0002.812± 1.1377
OG0012.933± 1.5977
OG0022.822± 1.3294
OG0032.979± 1.7673
Title
Measurements
OG0003.078± 1.5948
OG0012.716± 1.1022
OG0022.665± 1.0287
OG0032.858± 1.1909
Title
Measurements
OG0002.958± 1.2918
OG0012.904± 1.1794
OG0022.989± 1.6589
OG0033.187± 1.6424
Title
Measurements
OG0003.151± 1.2378
OG0012.996± 1.5425
OG0022.884± 1.0047
OG0033.142± 1.6483
Title
Measurements
OG0002.885± 1.0874
OG0012.958± 1.2097
OG0022.830± 1.0354
OG0032.886± 1.3159
Title
Measurements
OG0003.183± 1.0674
OG0013.005± 1.0029
OG0022.989± 1.4078
OG0032.916± 1.0731
Title
Measurements
OG0002.797± 0.9490
OG0013.036± 1.1931
OG0023.167± 1.3992
OG0033.174± 1.7150
Title
Measurements
OG0003.162± 1.1538
OG0012.916± 1.2331
OG0023.010± 1.0698
OG0032.914± 1.2530
Title
Measurements
OG0003.155± 1.3417
OG0013.065± 1.2945
OG0023.050± 1.0745
OG0033.187± 1.6006
Title
Measurements
OG0003.138± 1.3751
OG0013.132± 1.1976
OG0023.004± 1.1720
OG0033.134± 1.6646
Title
Measurements
OG0003.164± 1.3804
OG0013.333± 1.5642
OG0023.200± 1.2159
OG0033.269± 1.3866
Title
Measurements
OG0003.197± 1.2931
OG0013.131± 1.2337
OG0023.163± 1.0874
OG0033.361± 1.8047
Title
Measurements
OG0003.245± 1.4593
OG0013.385± 1.3591
OG0023.512± 1.3176
OG0033.259± 1.6532
Title
Measurements
OG0003.466± 1.1229
OG0013.540± 1.7870
OG0023.494± 1.2790
OG0033.297± 1.4509
Title
Measurements
OG000212.5± 53.22
OG001202.3± 51.74
OG002190.0± 55.71
OG003200.1± 52.36
Title
Measurements
OG000225.0± 54.84
OG001222.0± 48.82
OG002204.8± 50.51
OG003216.2± 52.60
Title
Measurements
OG000225.2± 52.94
OG001222.4± 52.61
OG002204.6± 57.51
OG003216.0± 55.41
Title
Measurements
OG000224.5± 50.94
OG001228.4± 57.01
OG002211.5± 56.80
OG003209.8± 48.62
Title
Measurements
OG000227.2± 49.64
OG001216.4± 52.46
OG002209.2± 51.62
OG003213.7± 50.65
Title
Measurements
OG000230.0± 59.33
OG001212.4± 54.22
OG002209.5± 50.32
OG003211.4± 50.56
Title
Measurements
OG000231.3± 55.14
OG001215.5± 47.03
OG002205.4± 48.40
OG003214.9± 51.41
Title
Measurements
OG000226.1± 52.17
OG001219.7± 50.75
OG002210.9± 56.34
OG003220.9± 67.67
Title
Measurements
OG000224.9± 56.06
OG001215.5± 53.10
OG002199.4± 60.65
OG003214.4± 53.90
Title
Measurements
OG000223.3± 50.28
OG001217.0± 56.54
OG002209.8± 56.65
OG003215.4± 57.81
Title
Measurements
OG000220.5± 55.37
OG001214.0± 46.66
OG002207.8± 53.33
OG003212.6± 52.27
Title
Measurements
OG000220.0± 47.58
OG001212.1± 51.61
OG002204.2± 54.34
OG003209.8± 52.54
Title
Measurements
OG000224.9± 52.93
OG001210.1± 55.87
OG002199.3± 52.37
OG003217.7± 54.40
Title
Measurements
OG000225.6± 60.05
OG001221.2± 56.12
OG002209.9± 56.81
OG003220.3± 52.52
Title
Measurements
OG000232.5± 57.00
OG001219.8± 55.01
OG002212.2± 53.68
OG003230.5± 56.39
Title
Measurements
OG000234.0± 52.53
OG001224.4± 50.06
OG002212.2± 52.59
OG003225.9± 52.62
Title
Measurements
OG000224.8± 52.36
OG001218.8± 49.15
OG002210.1± 51.72
OG003216.5± 53.09
Title
Measurements
OG000237.1± 58.94
OG001221.8± 57.95
OG002210.6± 57.34
OG003214.0± 51.10
Title
Measurements
OG0005.06± 1.552
OG0015.19± 1.632
OG0024.72± 1.332
OG0034.70± 1.388
Title
Measurements
OG0005.32± 1.602
OG0015.30± 1.448
OG0025.02± 1.355
OG0035.45± 1.856
Title
Measurements
OG0005.24± 1.802
OG0015.17± 1.604
OG0025.02± 1.342
OG0035.02± 1.993
Title
Measurements
OG0005.44± 1.751
OG0015.30± 1.556
OG0025.04± 1.230
OG0035.02± 1.195
Title
Measurements
OG0005.41± 1.560
OG0015.50± 1.794
OG0025.34± 1.524
OG0035.27± 1.899
Title
Measurements
OG0005.56± 1.895
OG0015.20± 1.337
OG0024.97± 1.108
OG0035.13± 1.480
Title
Measurements
OG0005.46± 1.486
OG0015.41± 1.354
OG0025.39± 1.877
OG0035.50± 1.763
Title
Measurements
OG0005.57± 1.558
OG0015.53± 1.993
OG0025.28± 1.367
OG0035.34± 1.854
Title
Measurements
OG0005.30± 1.294
OG0015.50± 1.642
OG0025.29± 1.315
OG0035.08± 1.381
Title
Measurements
OG0005.71± 1.426
OG0015.53± 1.493
OG0025.38± 1.542
OG0035.14± 1.254
Title
Measurements
OG0005.30± 1.399
OG0015.63± 1.456
OG0025.57± 1.720
OG0035.48± 1.939
Title
Measurements
OG0005.64± 1.461
OG0015.48± 1.756
OG0025.56± 1.303
OG0035.17± 1.312
Title
Measurements
OG0005.63± 1.607
OG0015.61± 1.687
OG0025.45± 1.255
OG0035.51± 1.808
Title
Measurements
OG0005.51± 1.663
OG0015.72± 1.695
OG0025.41± 1.314
OG0035.53± 1.818
Title
Measurements
OG0005.73± 1.749
OG0015.93± 1.677
OG0025.63± 1.491
OG0035.75± 1.608
Title
Measurements
OG0005.80± 1.671
OG0015.71± 1.550
OG0025.73± 1.297
OG0035.84± 2.104
Title
Measurements
OG0005.91± 1.845
OG0016.11± 1.718
OG0026.05± 1.469
OG0035.78± 1.658
Title
Measurements
OG0006.14± 1.622
OG0016.15± 1.933
OG0026.01± 1.489
OG0035.75± 1.556
-1.3
± 23.63
Title
Measurements
OG000-0.7± 8.94
OG001-2.6± 12.13
OG0021.7± 22.01
OG0030.1± 29.43
Title
Measurements
OG0002.2± 10.71
OG0010.5± 18.49
OG0028.0± 56.59
OG003-6.3± 29.64
Title
Measurements
OG0001.2± 8.91
OG0012.7± 24.70
OG002-0.6± 13.40
OG003-6.3± 33.57
Title
Measurements
OG0002.1± 19.92
OG0010.1± 27.07
OG002-0.3± 13.36
OG003-1.6± 38.90
Title
Measurements
OG000-0.7± 8.58
OG001-3.6± 14.07
OG0023.0± 18.56
OG003-4.8± 34.09
Title
Measurements
OG000-2.1± 7.93
OG001-1.2± 20.79
OG0021.4± 19.49
OG003-6.0± 33.13
Title
Measurements
OG0001.1± 16.32
OG001-2.6± 24.31
OG002-1.7± 13.07
OG003-3.7± 41.02
Title
Measurements
OG000-2.3± 7.87
OG001-2.3± 25.40
OG002-2.9± 17.79
OG003-8.1± 33.92
Title
Measurements
OG000-3.1± 8.55
OG001-1.7± 25.75
OG002-4.0± 13.90
OG003-8.6± 34.85
Title
Measurements
OG0000.8± 23.68
OG001-4.2± 17.84
OG002-3.0± 15.31
OG003-8.2± 32.34
Title
Measurements
OG0000.1± 15.48
OG001-4.1± 15.85
OG002-1.4± 15.96
OG003-8.0± 32.36
Title
Measurements
OG000-4.1± 9.03
OG001-3.8± 17.77
OG002-2.4± 14.60
OG003-8.6± 34.80
Title
Measurements
OG000-1.0± 15.72
OG001-2.6± 17.74
OG0020.5± 18.13
OG003-6.3± 36.82
Title
Measurements
OG000-2.8± 9.92
OG0012.7± 30.95
OG002-0.9± 15.27
OG003-8.5± 36.32
Title
Measurements
OG000-2.4± 10.87
OG0011.9± 22.60
OG002-2.0± 16.90
OG003-4.0± 49.06
Title
Measurements
OG000-0.4± 18.47
OG00120.6± 154.71
OG002-1.7± 17.12
OG003-7.6± 20.22
Title
Measurements
OG0000.5± 11.41
OG001-2.7± 20.04
OG002-0.7± 20.63
Title
Measurements
OG0004.4± 23.14
OG001-2.6± 18.42
OG002-3.7± 15.82
Title
Measurements
OG0004.3± 23.58
OG001-3.0± 20.18
OG002-3.8± 17.80
Title
Measurements
OG0000.1± 13.01
OG001-3.4± 17.81
OG002-1.8± 15.40
Title
Measurements
OG000-0.5± 13.86
OG001-1.8± 19.51
OG002-2.2± 27.94
Title
Measurements
OG0002.3± 11.40
OG001-1.1± 19.14
OG002-3.6± 24.29
Title
Measurements
OG0001.7± 12.96
OG001-2.8± 15.68
OG002-1.2± 31.69
Title
Measurements
OG0004.9± 17.56
OG001-3.3± 16.07
OG0021.3± 35.53
Title
Measurements
OG0001.9± 11.42
OG001-1.7± 16.25
OG002-3.4± 24.00
Title
Measurements
OG0001.7± 11.28
OG001-3.0± 13.37
OG002-2.7± 26.90
Title
Measurements
OG00036.8± 162.51
OG001-1.1± 13.68
OG0020.5± 17.72
Title
Measurements
OG0005.3± 38.37
OG001-0.1± 16.56
OG002-0.7± 18.20
Title
Measurements
OG0002.0± 18.06
OG0012.8± 22.54
OG002-1.6± 20.95
Title
Measurements
OG0003.3± 19.88
OG0010.7± 23.29
OG0022.0± 29.60
Title
Measurements
OG0003.3± 19.97
OG0012.9± 31.30
OG0021.1± 23.92
Title
Measurements
OG0006.6± 24.89
OG0011.2± 27.16
OG0021.9± 26.19
Title
Measurements
OG0004.8± 25.46
OG001-1.4± 19.21
OG002-1.8± 24.06
Title
Measurements
OG0005.5± 25.29
OG0017.6± 42.61
OG0020.0± 22.51
Title
Measurements
OG00017.7± 40.15
OG0011.3± 8.73
OG0021.0± 4.36
Title
Measurements
OG0000.7± 6.11
OG001-1.3± 11.20
OG002-1.6± 8.85
OG0030.9± 58.63
Title
Measurements
OG000-1.0± 5.96
OG001-2.8± 8.97
OG0020.1± 14.56
OG003-2.9± 31.52
Title
Measurements
OG0004.2± 30.51
OG0011.5± 22.15
OG0025.3± 36.86
OG003-7.3± 29.65
Title
Measurements
OG0001.3± 10.43
OG0011.6± 21.65
OG002-1.7± 8.91
OG003-7.9± 32.18
Title
Measurements
OG000-0.7± 10.43
OG0011.9± 23.46
OG002-0.6± 8.03
OG0034.4± 79.53
Title
Measurements
OG0001.3± 18.94
OG001-3.1± 10.44
OG0024.6± 23.87
OG003-3.6± 41.56
Title
Measurements
OG000-1.4± 7.81
OG001-0.3± 15.64
OG0021.5± 15.03
OG003-2.1± 13.59
Title
Measurements
OG0003.3± 28.47
OG001-0.9± 16.10
OG002-1.7± 8.21
OG003-2.6± 17.81
Title
Measurements
OG000-2.0± 6.39
OG001-0.2± 15.51
OG002-1.9± 13.67
OG003-5.1± 15.42
Title
Measurements
OG000-2.7± 5.77
OG001-1.0± 16.15
OG002-1.4± 9.19
OG003-2.8± 17.86
Title
Measurements
OG0004.6± 38.77
OG001-2.1± 12.13
OG002-0.6± 11.86
OG003-1.9± 17.93
Title
Measurements
OG0000.1± 13.12
OG001-2.9± 10.87
OG002-0.5± 14.40
OG003-5.1± 14.94
Title
Measurements
OG000-3.3± 7.99
OG001-3.2± 12.28
OG002-3.0± 8.28
OG003-4.4± 16.67
Title
Measurements
OG000-0.9± 9.05
OG001-2.0± 13.06
OG0023.0± 18.70
OG003-3.2± 17.49
Title
Measurements
OG000-2.7± 6.70
OG0013.7± 24.41
OG002-0.5± 9.75
OG003-4.6± 15.69
Title
Measurements
OG000-2.2± 7.56
OG0012.0± 19.02
OG002-1.8± 9.46
OG0032.3± 40.93
Title
Measurements
OG000-0.8± 22.39
OG00120.5± 150.10
OG002-1.0± 12.58
OG003-0.3± 25.99
Title
Measurements
OG000-1.0± 10.89
OG001-4.0± 11.71
OG0020.6± 22.77
Title
Measurements
OG0000.1± 13.16
OG001-2.5± 13.44
OG002-2.4± 10.90
Title
Measurements
OG000-0.2± 11.50
OG001-3.9± 12.40
OG0020.7± 32.61
Title
Measurements
OG000-3.4± 8.19
OG001-4.3± 13.76
OG002-3.9± 9.45
Title
Measurements
OG000-3.0± 8.78
OG001-3.2± 13.94
OG002-4.1± 13.08
Title
Measurements
OG000-0.8± 8.95
OG001-3.4± 12.15
OG002-3.8± 13.44
Title
Measurements
OG000-1.9± 7.91
OG001-4.2± 12.71
OG002-2.9± 17.09
Title
Measurements
OG000-1.5± 8.89
OG001-5.3± 11.00
OG0020.1± 20.52
Title
Measurements
OG000-1.7± 7.88
OG001-4.8± 10.98
OG002-4.5± 12.04
Title
Measurements
OG000-2.7± 6.40
OG001-4.9± 11.54
OG002-4.3± 13.42
Title
Measurements
OG00013.5± 72.97
OG001-5.9± 11.78
OG002-2.8± 10.14
Title
Measurements
OG000-1.0± 21.51
OG001-5.3± 11.70
OG002-3.4± 11.32
Title
Measurements
OG000-2.2± 10.89
OG001-2.1± 15.31
OG002-3.9± 11.09
Title
Measurements
OG000-1.6± 10.61
OG001-4.3± 15.09
OG002-2.9± 12.87
Title
Measurements
OG000-1.5± 10.00
OG001-3.3± 14.38
OG002-1.4± 12.80
Title
Measurements
OG000-1.4± 11.87
OG001-3.6± 14.93
OG002-2.2± 12.98
Title
Measurements
OG000-2.0± 9.56
OG001-5.3± 13.01
OG002-4.1± 12.07
Title
Measurements
OG00011.7± 82.61
OG001-2.3± 17.39
OG002-0.3± 14.27
Title
Measurements
OG0002.7± 12.66
OG001-5.3± 14.59
OG002-6.7± 4.16
Title
Measurements
OG00040.0± 234.19
OG001-32.2± 664.29
OG0020.4± 183.47
OG003159.8± 3217.64
Title
Measurements
OG000-2.3± 125.78
OG001-82.0± 586.36
OG002-2.9± 227.73
OG003-120.3± 1656.37
Title
Measurements
OG000216.9± 1495.44
OG001115.8± 1625.63
OG002266.7± 1787.23
OG003-212.8± 1579.19
Title
Measurements
OG000120.6± 551.72
OG00139.8± 1035.75
OG00227.1± 208.15
OG003-220.1± 1656.33
Title
Measurements
OG000-2.0± 177.01
OG001156.3± 1399.82
OG00228.6± 218.04
OG003269.7± 3855.01
Title
Measurements
OG000144.2± 969.11
OG001-68.9± 542.73
OG002298.9± 1661.14
OG003135.3± 3115.23
Title
Measurements
OG00027.5± 241.96
OG00132.4± 800.50
OG00255.9± 252.05
OG003103.9± 482.18
Title
Measurements
OG000133.7± 612.97
OG001-16.3± 616.41
OG00254.4± 316.26
OG00321.2± 162.22
Title
Measurements
OG0009.8± 179.35
OG00174.1± 542.07
OG00296.8± 475.89
OG0034.1± 159.24
Title
Measurements
OG0003.1± 159.46
OG001-25.1± 605.67
OG002122.1± 364.15
OG003110.3± 794.67
Title
Measurements
OG000325.9± 1995.64
OG001-33.6± 572.93
OG00266.1± 276.38
OG003158.7± 625.32
Title
Measurements
OG00057.1± 350.15
OG001-48.6± 502.19
OG002103.5± 390.10
OG0033.8± 128.31
Title
Measurements
OG000-1.3± 173.80
OG001-54.7± 612.26
OG00228.6± 196.37
OG0032.8± 124.04
Title
Measurements
OG000115.4± 743.67
OG001-80.1± 598.41
OG002206.2± 880.62
OG00324.5± 158.37
Title
Measurements
OG000-19.8± 152.46
OG00153.8± 1031.26
OG00267.6± 311.66
OG003-14.3± 92.49
Title
Measurements
OG000-0.7± 147.67
OG00133.6± 900.48
OG00214.9± 211.36
OG003123.9± 598.22
Title
Measurements
OG000335.4± 2431.93
OG001-22.8± 768.54
OG00219.6± 249.41
OG003143.9± 903.29
Title
Measurements
OG00064.2± 339.96
OG001-88.5± 592.61
OG002100.3± 546.46
Title
Measurements
OG00011.5± 229.39
OG001-48.9± 614.32
OG00261.4± 304.98
Title
Measurements
OG00030.6± 198.34
OG001-41.3± 654.65
OG002649.6± 3895.73
Title
Measurements
OG00010.6± 143.04
OG001-72.4± 637.65
OG00268.7± 192.20
Title
Measurements
OG000-5.3± 178.55
OG001-87.9± 626.53
OG00273.3± 396.95
Title
Measurements
OG00027.7± 149.18
OG001-60.7± 648.64
OG00274.4± 492.75
Title
Measurements
OG00022.4± 120.72
OG001-16.4± 769.12
OG00262.8± 325.34
Title
Measurements
OG0005.2± 123.98
OG001-98.5± 666.21
OG00298.6± 393.41
Title
Measurements
OG00079.1± 253.58
OG001-101.8± 642.05
OG00248.3± 148.37
Title
Measurements
OG00043.2± 232.12
OG001-74.4± 658.64
OG00241.9± 177.16
Title
Measurements
OG00064.0± 332.07
OG001-129.0± 640.89
OG00240.4± 133.68
Title
Measurements
OG0001.2± 118.21
OG001-108.1± 646.43
OG00292.0± 285.12
Title
Measurements
OG00024.6± 96.40
OG001-110.1± 645.37
OG00262.5± 201.59
Title
Measurements
OG0001.9± 135.22
OG001-31.3± 819.97
OG00238.9± 137.90
Title
Measurements
OG00039.9± 258.45
OG001-126.5± 639.63
OG002146.4± 350.73
Title
Measurements
OG00021.6± 139.26
OG001-98.5± 642.79
OG00243.4± 172.08
Title
Measurements
OG00025.3± 129.65
OG001-100.7± 684.43
OG00256.0± 195.62
Title
Measurements
OG000727.5± 4047.61
OG001-141.3± 681.29
OG002209.4± 862.10
Title
Measurements
OG000-1.3± 168.42
OG001-195.0± 417.89
OG002102.7± 157.82
0.65
± 7.483
Title
Measurements
OG0002.24± 6.889
OG0012.50± 7.401
OG0024.08± 8.072
OG003-0.32± 5.817
Title
Measurements
OG0002.38± 8.371
OG0012.06± 6.775
OG0023.44± 8.717
OG003-0.92± 9.006
Title
Measurements
OG0003.39± 8.591
OG0011.59± 9.300
OG0023.79± 8.634
OG003-1.42± 9.022
Title
Measurements
OG0002.91± 11.874
OG0011.10± 6.923
OG0022.09± 8.967
OG003-2.92± 7.744
Title
Measurements
OG0002.54± 6.384
OG0010.85± 7.713
OG0025.29± 9.360
OG003-3.26± 8.085
Title
Measurements
OG0002.52± 7.225
OG0012.44± 9.391
OG0024.45± 9.743
OG003-2.03± 15.306
Title
Measurements
OG0002.74± 7.750
OG0011.80± 8.796
OG0026.03± 8.465
OG003-2.67± 9.311
Title
Measurements
OG0002.22± 6.606
OG0012.80± 8.908
OG0025.01± 9.028
OG003-3.42± 8.042
Title
Measurements
OG0003.36± 8.462
OG0011.69± 9.226
OG0025.00± 8.690
OG003-3.50± 7.887
Title
Measurements
OG0003.11± 6.652
OG0013.41± 8.115
OG0026.00± 8.059
OG003-3.26± 7.392
Title
Measurements
OG0002.83± 7.966
OG0012.36± 8.318
OG0024.76± 7.858
OG003-2.83± 9.423
Title
Measurements
OG0002.75± 9.061
OG0012.18± 8.280
OG0024.47± 7.883
OG003-2.73± 8.533
Title
Measurements
OG0003.28± 7.507
OG0012.30± 7.998
OG0024.46± 9.058
OG003-3.87± 7.866
Title
Measurements
OG0003.89± 7.917
OG0014.71± 7.934
OG0026.59± 10.595
OG003-4.48± 8.461
Title
Measurements
OG0004.58± 9.834
OG0013.80± 8.761
OG0026.53± 8.328
OG003-2.48± 8.697
Title
Measurements
OG0001.90± 11.248
OG0015.34± 10.813
OG0027.76± 10.318
OG003-2.28± 10.222
Title
Measurements
OG0005.87± 9.133
OG0015.18± 7.296
OG0027.26± 10.273
Title
Measurements
OG0004.41± 8.648
OG0014.15± 7.099
OG0026.78± 11.811
Title
Measurements
OG0003.76± 8.272
OG0014.02± 6.551
OG0024.99± 12.168
Title
Measurements
OG0005.99± 11.083
OG0015.80± 6.861
OG0025.07± 10.449
Title
Measurements
OG0005.28± 8.225
OG0016.36± 6.819
OG0025.16± 9.056
Title
Measurements
OG0006.57± 8.702
OG0015.62± 8.355
OG0026.82± 9.644
Title
Measurements
OG0005.89± 6.964
OG0015.08± 7.638
OG0025.91± 11.737
Title
Measurements
OG0006.90± 9.792
OG0017.91± 9.528
OG0025.90± 11.316
Title
Measurements
OG0006.21± 9.019
OG0016.46± 8.491
OG0025.16± 10.629
Title
Measurements
OG0008.34± 7.736
OG0019.31± 10.863
OG0027.42± 8.996
Title
Measurements
OG0007.16± 10.365
OG0017.19± 7.388
OG0026.61± 10.415
Title
Measurements
OG0008.48± 10.016
OG0017.33± 9.459
OG0027.08± 10.649
Title
Measurements
OG0006.96± 8.206
OG0017.52± 9.245
OG0027.64± 11.727
Title
Measurements
OG0005.97± 7.510
OG0017.10± 9.486
OG0026.99± 12.140
Title
Measurements
OG0007.89± 8.309
OG0015.84± 10.581
OG0026.19± 10.418
Title
Measurements
OG0008.81± 8.348
OG0017.84± 9.546
OG0026.20± 12.890
Title
Measurements
OG00010.49± 8.321
OG0019.16± 9.580
OG0028.19± 12.114
Title
Measurements
OG0007.98± 8.645
OG0017.86± 9.096
OG0027.10± 12.061
Title
Measurements
OG00015.90± 6.636
OG0019.75± 8.155
OG0025.03± 4.007
Title
Measurements
OG0000.0± 3.20
OG001-0.3± 2.71
OG002-0.4± 4.89
OG003-3.0± 3.82
Title
Measurements
OG0000.1± 3.39
OG001-0.3± 3.90
OG002-0.8± 5.90
OG003-3.4± 4.06
Title
Measurements
OG0000.0± 3.99
OG001-0.5± 3.83
OG002-0.6± 5.62
OG003-3.4± 4.24
Title
Measurements
OG0000.4± 5.43
OG001-0.9± 3.77
OG002-0.5± 5.61
OG003-2.4± 3.75
Title
Measurements
OG0000.4± 3.96
OG001-1.2± 3.74
OG002-0.2± 4.93
OG003-2.4± 3.79
Title
Measurements
OG000-0.1± 3.96
OG001-0.7± 3.63
OG002-0.4± 7.27
OG003-2.6± 3.83
Title
Measurements
OG0000.5± 4.26
OG0010.2± 4.45
OG002-0.7± 5.69
OG003-2.9± 3.86
Title
Measurements
OG0001.1± 4.97
OG0010.5± 3.81
OG0021.0± 5.80
OG003-2.7± 3.44
Title
Measurements
OG0001.1± 4.39
OG0010.7± 5.19
OG0020.5± 5.25
OG003-2.8± 4.01
Title
Measurements
OG0000.7± 3.79
OG0010.2± 4.99
OG0020.9± 6.82
OG003-2.6± 3.78
Title
Measurements
OG0001.2± 4.94
OG0010.6± 4.92
OG0021.4± 6.40
OG003-2.7± 3.62
Title
Measurements
OG0001.6± 5.03
OG0011.7± 4.75
OG0021.5± 6.30
OG003-2.9± 3.67
Title
Measurements
OG0000.9± 4.58
OG0010.1± 4.51
OG002-0.3± 5.37
OG003-2.6± 3.80
Title
Measurements
OG0001.9± 4.31
OG0010.0± 4.78
OG0020.9± 6.56
OG003-2.2± 3.86
Title
Measurements
OG0001.5± 6.05
OG0010.1± 4.59
OG0020.6± 6.36
OG003-2.7± 3.69
Title
Measurements
OG0002.3± 5.09
OG0010.1± 5.07
OG0021.2± 5.49
OG003-2.6± 4.27
Title
Measurements
OG0001.0± 4.15
OG0010.0± 5.80
OG0021.7± 5.42
OG003-2.5± 3.92
Title
Measurements
OG0000.7± 4.86
OG0011.4± 6.34
OG0020.8± 5.89
Title
Measurements
OG0000.9± 4.96
OG0011.1± 4.72
OG0021.3± 7.40
Title
Measurements
OG0001.0± 6.16
OG0012.0± 8.03
OG0021.1± 6.40
Title
Measurements
OG0000.7± 4.70
OG0011.1± 7.00
OG0020.4± 6.50
Title
Measurements
OG0001.6± 5.07
OG0011.0± 5.23
OG0021.0± 6.93
Title
Measurements
OG0001.1± 5.37
OG0010.8± 4.19
OG0021.4± 5.94
Title
Measurements
OG0001.1± 5.54
OG0010.0± 4.29
OG0021.0± 7.42
Title
Measurements
OG0000.7± 5.88
OG0010.3± 4.80
OG0020.9± 6.18
Title
Measurements
OG0001.1± 5.31
OG0010.7± 3.71
OG0020.6± 6.61
Title
Measurements
OG0000.5± 5.08
OG0010.8± 6.69
OG0020.3± 5.91
Title
Measurements
OG0001.6± 4.61
OG0010.5± 3.77
OG002-0.3± 5.71
Title
Measurements
OG0001.2± 4.92
OG0010.9± 4.72
OG002-0.1± 4.83
Title
Measurements
OG0001.4± 5.71
OG0012.0± 6.03
OG0020.2± 6.21
Title
Measurements
OG0000.4± 5.76
OG0012.9± 8.95
OG002-0.1± 6.11
Title
Measurements
OG0000.7± 3.52
OG0012.8± 10.40
OG0020.9± 6.46
Title
Measurements
OG0000.5± 5.06
OG0011.9± 7.87
OG0020.0± 6.10
Title
Measurements
OG0001.1± 4.22
OG0011.7± 8.78
OG0020.9± 5.18
Title
Measurements
OG0001.4± 5.30
OG0011.1± 7.12
OG0020.8± 5.52
Title
Measurements
OG0005.3± 4.16
OG0015.5± 11.47
OG0020.7± 4.16
Title
Measurements
OG000-1.4± 12.20
OG001-3.7± 12.18
OG002-4.9± 14.83
OG003-0.1± 10.06
Title
Measurements
OG0005.5± 26.16
OG001-1.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG0027.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
OG0030.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG0002.2± 37.66
OG0010.2± 15.60
OG002-2.7± 13.89
OG0033.4± 12.94
Title
Measurements
OG0008.0± 7.07
OG0034.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG000-2.7± 22.03
OG001-6.4± 34.13
OG002-5.8± 14.77
OG0034.8± 15.66
Title
Measurements
OG001-7.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG001-95.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG000-2.6± 12.72
OG001-1.1± 16.63
OG002-4.5± 14.27
OG0030.4± 19.04
Title
Measurements
OG00316.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG0002.2± 31.70
OG001-2.4± 20.43
OG002-9.0± 16.95
OG0035.1± 22.48
Title
Measurements
OG0001.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG001-23.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG0010.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point
Title
Measurements
OG002-143.0± NAStandard deviation could not be calculated as only one participant was analyzed at the specified time point