Trial of Maraviroc (UK-427,857) in Combination With Optim... | NCT00098306 | Trialant
NCT00098306
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Apr 27, 2012Estimated
Enrollment
601Actual
Phase
Phase 2Phase 3
Conditions
HIV Infections
Interventions
Maraviroc (UK-427,857)
Optimized Background Therapy
Optimized Background Therapy
Placebo
Optimized Background Therapy
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00098306
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4001027
Secondary IDs
Not provided
Brief Title
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.
Acronym
MOTIVATE 1
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Apr 2012
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
Nov 2004
Primary Completion Date
Apr 2007Actual
Completion Date
Apr 2011Actual
First Submitted Date
Dec 6, 2004
First Submission Date that Met QC Criteria
Dec 6, 2004
First Posted Date
Dec 7, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 2, 2012
Results First Submitted that Met QC Criteria
Apr 2, 2012
Results First Posted Date
Apr 27, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 2, 2012
Last Update Posted Date
Apr 27, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
Not provided
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
601Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Drug: Maraviroc (UK-427,857)
Drug: Optimized Background Therapy
2
Experimental
Drug: Optimized Background Therapy
Drug: Placebo
3
Experimental
Drug: Optimized Background Therapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Maraviroc (UK-427,857)
Drug
Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline and Week 24
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization and immediately pre-dose.
Baseline and Week 48
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Week 24 and 48
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline
Week 24 and 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities)
HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL
Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks
Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide
Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)
Effective barrier contraception for WOCBP and males
Exclusion Criteria:
Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)
Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days
Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days
Active alcohol or substance abuse sufficient, in the Investigator's judgement, to prevent adherence to study medication and/or follow up
Lactating women, or planned pregnancy during the trial period
Significant renal insufficiency
Previous therapy with a potentially myelosuppressive, neurotoxic, hepatoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period
Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
Significantly elevated liver enzymes or cirrhosis
Significant neutropenia, anemia or thrombocytopenia
Malabsorption or an inability to tolerate oral medications
Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease
Certain medications
Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
X4- or dual/mixed-tropic virus or repeated assay failure
Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
1
Optimized Background Therapy
Drug
Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
2
Placebo
Drug
Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
2
Optimized Background Therapy
Drug
Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment.
3
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline
Week 24 and 48
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Week 24 and 48
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Baseline
Change From Baseline in CD4 Cell Count at Week 24 and 48
Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.
Baseline, Week 24 and 48
Change From Baseline in CD8 Cell Count at Week 24 and 48
Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.
Baseline, Week 24 and 48
Time to Virological Failure
Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
Week 48
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline to Week 24 and Week 48
Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Screening
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Screening and time of failure through week 24
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Screening and time of failure through week 48
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
Baseline and time of failure through week 24
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
Baseline and time of failure through week 48
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
Baseline, Week 24 and Week 48
San Francisco
California
94115
United States
Pfizer Investigational Site
San Francisco
California
94118
United States
Pfizer Investigational Site
San Francisco
California
94121
United States
Pfizer Investigational Site
Auroa
Colorado
80045
United States
Pfizer Investigational Site
Aurora
Colorado
80045
United States
Pfizer Investigational Site
Washington D.C.
District of Columbia
20036
United States
Pfizer Investigational Site
Tampa
Florida
33602
United States
Pfizer Investigational Site
Tampa
Florida
33614
United States
Pfizer Investigational Site
Vero Beach
Florida
32960
United States
Pfizer Investigational Site
Atlanta
Georgia
30308
United States
Pfizer Investigational Site
New Orleans
Louisiana
70112
United States
Pfizer Investigational Site
Santa Fe
New Mexico
87505
United States
Pfizer Investigational Site
New York
New York
10003
United States
Pfizer Investigational Site
Rochester
New York
14642
United States
Pfizer Investigational Site
The Bronx
New York
10467
United States
Pfizer Investigational Site
Cincinnati
Ohio
45267-0405
United States
Pfizer Investigational Site
Portland
Oregon
97219
United States
Pfizer Investigational Site
Austin
Texas
78705
United States
Pfizer Investigational Site
Annandale
Virginia
22003
United States
Pfizer Investigational Site
Vancouver
British Columbia
V6Z 1Y6
Canada
Pfizer Investigational Site
Montreal
Quebec
H2L 4P9
Canada
Derived
Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.
Hardy WD, Gulick RM, Mayer H, Fatkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.
Fatkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.
Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.
FG001
Maraviroc BID, Double Blind
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
FG002
Placebo, Double Blind
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
FG003
Maraviroc BID, Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
FG004
In Study-off Drug (ISOD), Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
FG005
Maraviroc BID, Observation Phase
Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
FG006
In Study-off Drug (ISOD), Observation Phase
Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
FG000241 subjects
FG001240 subjects
FG002120 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Treated
FG000232 subjects
FG001235 subjects
FG002118 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000241 subjects
FG001240 subjects
FG002120 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Randomized, not treated
FG0009 subjects
FG0015 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Ongoing at cut-off date
FG000151 subjects
FG001166 subjects
FG00272 subjects
FG0030 subjects
FG004
Adverse Event
FG00011 subjects
FG00110 subjects
FG0026 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00043 subjects
FG00134 subjects
FG00217 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0014 subjects
FG0021 subjects
FG0030 subjects
FG004
Participant defaulted
FG00019 subjects
FG00118 subjects
FG00211 subjects
FG0030 subjects
FG004
Un-specified
FG0007 subjects
FG0013 subjects
FG00211 subjects
FG0030 subjects
FG004
Open Label
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003327 subjects
FG00462 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003327 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Observational Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005250 subjects
FG00681 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
BG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
BG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000232
BG001235
BG002118
BG003585
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Out of a total of 601 participants, data for baseline measure (age) was available for 585 participants who were treated.
Number
participants
Title
Denominators
Categories
Less than 18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Out of a total of 601 participants, data for baseline measure (gender) was available for 585 participants who were treated.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00123
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
Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.
Posted
Mean
Standard Deviation
log10 copies/milliliter(log10 copies/mL)
Baseline
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Title
Measurements
OG0004.854± 0.641
OG0014.861± 0.614
OG0024.840± 0.556
Primary
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Baseline and Week 24
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Posted
Mean
Standard Deviation
cells per microliter (cells/µL)
Baseline
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Secondary
Change From Baseline in CD4 Cell Count at Week 24 and 48
Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.
Posted
Least Squares Mean
Standard Error
cells/µL
Baseline, Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Secondary
Change From Baseline in CD8 Cell Count at Week 24 and 48
Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.
Posted
Least Squares Mean
Standard Error
cells/µL
Baseline, Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Secondary
Time to Virological Failure
Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
FAS included all the randomized participants who had taken at least one dose of the study medication.
Posted
Median
95% Confidence Interval
days
Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Baseline to Week 24 and Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Primary
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Baseline and Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
FAS included all the randomized participants who had taken at least one dose of the study medication.
Posted
Number
participants
Screening
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.
Posted
Number
participants
Screening and time of failure through week 24
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Secondary
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.
Posted
Number
participants
Screening and time of failure through week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Secondary
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.
Posted
Number
participants
Baseline and time of failure through week 24
ID
Title
Description
OG000
Maraviroc QD
Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.
Posted
Number
participants
Baseline and time of failure through week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm at particular time-point. LOCF was used to impute missing values.
Posted
Mean
Standard Deviation
log10copies/mL
Baseline, Week 24 and Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the 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
Maraviroc QD, Double Blind
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
42
232
170
232
EG001
Maraviroc BID, Double Blind
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
53
235
192
235
EG002
Placebo, Double Blind
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
20
118
89
118
EG003
Maraviroc BID, Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
33
327
19
327
EG004
In Study-off Drug (ISOD), Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
0
62
0
62
EG005
Maraviroc BID, Observation Phase
Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
0
250
0
250
EG006
In Study-off Drug (ISOD), Observation Phase
Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
0
81
0
81
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0011 affected235 at risk
EG0021 affected118 at risk
EG0030 affected327 at risk
EG0040 affected62 at risk
EG0050 affected250 at risk
EG0060 affected81 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0021 affected118 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0021 affected118 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Visual impairment
Eye disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0011 affected235 at risk
EG0022 affected118 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0011 affected235 at risk
EG0021 affected118 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0003 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Asthenia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Chest pain
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0003 affected232 at risk
EG0011 affected235 at risk
EG0022 affected118 at risk
EG003
Malaise
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0015 affected235 at risk
EG0021 affected118 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Antiphospholipid syndrome
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Arthritis gonococcal
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Cavernous sinus thrombosis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Cytomegalovirus chorioretinitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0021 affected118 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Gangrene
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Gastric infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
HIV wasting syndrome
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Infective myositis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0007 affected232 at risk
EG0012 affected235 at risk
EG0024 affected118 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Urethral abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
HIV infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Lung infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Drug toxicity
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Heat exhaustion
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Blood amylase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Lipase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Transaminases increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Nuclear magnetic resonance imaging brain
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Weight decreased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Joint warmth
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Spinal disorder
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0012 affected235 at risk
EG0021 affected118 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0021 affected118 at risk
EG003
Sweat gland tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Sedation
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0022 affected118 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Pneumocephalus
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0012 affected235 at risk
EG0020 affected118 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hip surgery
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Plasmapheresis
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Stent placement
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0021 affected118 at risk
EG003
Toe operation
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Peripheral embolism
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Infarction
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected232 at risk
EG0010 affected235 at risk
EG0020 affected118 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected232 at risk
EG0011 affected235 at risk
EG0020 affected118 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00013 affected232 at risk
EG0019 affected235 at risk
EG0024 affected118 at risk
EG0030 affected327 at risk
EG0040 affected62 at risk
EG0050 affected250 at risk
EG0060 affected81 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00012 affected232 at risk
EG00113 affected235 at risk
EG0021 affected118 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00012 affected232 at risk
EG00116 affected235 at risk
EG0020 affected118 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00058 affected232 at risk
EG00153 affected235 at risk
EG00230 affected118 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00045 affected232 at risk
EG00148 affected235 at risk
EG00223 affected118 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00020 affected232 at risk
EG00115 affected235 at risk
EG00212 affected118 at risk
EG003
Fatigue
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00036 affected232 at risk
EG00146 affected235 at risk
EG00222 affected118 at risk
EG003
Injection site reaction
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00020 affected232 at risk
EG00124 affected235 at risk
EG00214 affected118 at risk
EG003
Malaise
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0003 affected232 at risk
EG0011 affected235 at risk
EG0026 affected118 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00013 affected232 at risk
EG0019 affected235 at risk
EG0023 affected118 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00019 affected232 at risk
EG00132 affected235 at risk
EG00213 affected118 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00020 affected232 at risk
EG00120 affected235 at risk
EG0029 affected118 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0005 affected232 at risk
EG00112 affected235 at risk
EG0023 affected118 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00014 affected232 at risk
EG00119 affected235 at risk
EG0029 affected118 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00015 affected232 at risk
EG00124 affected235 at risk
EG0025 affected118 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00036 affected232 at risk
EG00135 affected235 at risk
EG00210 affected118 at risk
EG003
Weight decreased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG00014 affected232 at risk
EG0018 affected235 at risk
EG0022 affected118 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG00019 affected232 at risk
EG00117 affected235 at risk
EG0024 affected118 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00019 affected232 at risk
EG00120 affected235 at risk
EG0023 affected118 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00011 affected232 at risk
EG00120 affected235 at risk
EG0028 affected118 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00014 affected232 at risk
EG0016 affected235 at risk
EG0025 affected118 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00012 affected232 at risk
EG00111 affected235 at risk
EG0025 affected118 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG00027 affected232 at risk
EG00125 affected235 at risk
EG0029 affected118 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG00034 affected232 at risk
EG00135 affected235 at risk
EG00219 affected118 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG00012 affected232 at risk
EG0019 affected235 at risk
EG0021 affected118 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG00015 affected232 at risk
EG00114 affected235 at risk
EG0024 affected118 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG00022 affected232 at risk
EG00125 affected235 at risk
EG0027 affected118 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00031 affected232 at risk
EG00137 affected235 at risk
EG0028 affected118 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected232 at risk
EG00115 affected235 at risk
EG0024 affected118 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00014 affected232 at risk
EG00116 affected235 at risk
EG0024 affected118 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00011 affected232 at risk
EG00112 affected235 at risk
EG0022 affected118 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected232 at risk
EG00116 affected235 at risk
EG0023 affected118 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00019 affected232 at risk
EG00124 affected235 at risk
EG0026 affected118 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0006 affected232 at risk
EG00112 affected235 at risk
EG0021 affected118 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
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
D000077592
Maraviroc
Ancestor Terms
ID
Term
D003510
Cyclohexanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
62 subjects
FG0050 subjects
FG0060 subjects
13 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Participant defaulted
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00324 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Un-specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00315 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Ongoing at cut-off date
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003269 subjects
FG00462 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG005204 subjects
FG00655 subjects
0 subjects
FG00546 subjects
FG00626 subjects
0 subjects
FG0040 subjects
FG0055 subjects
FG0064 subjects
Participant defaulted
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00534 subjects
FG00618 subjects
Un-specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0057 subjects
FG0064 subjects
0
18 to 24 years
Title
Measurements
BG0001
BG0010
BG0020
BG0031
25 to 34 years
Title
Measurements
BG00010
BG0017
BG0025
BG00322
35 to 44 years
Title
Measurements
BG00097
BG001108
BG00248
BG003253
45 to 54 years
Title
Measurements
BG00093
BG00190
BG00245
BG003228
55 to 64 years
Title
Measurements
BG00026
BG00128
BG00219
BG00373
Greater than or equal to 65 years
Title
Measurements
BG0005
BG0012
BG0021
BG0038
BG002
12
BG00357
Male
BG000210
BG001212
BG002106
BG003528
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Title
Measurements
OG000-1.818± 0.0920
OG001-1.952± 0.0913
OG002-1.030± 0.1287
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-0.788
Standard Error of the Mean
0.1571
2-Sided
97.5
-1.141
-0.435
No
Superiority or Other
OG001
OG002
The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-0.922
Standard Error of the Mean
0.1568
2-Sided
97.5
-1.275
-0.570
No
Superiority or Other
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Week 24
Title
Measurements
OG00054.7
OG00160.4
OG00231.4
Week 48
Title
Measurements
OG00050.9
OG00157.5
OG00222.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than [<] 100,000 or greater than or equal to [>=] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (>) 1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
2.88
2-Sided
95
1.78
4.67
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.66
2-Sided
95
2.26
5.95
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.96
2-Sided
95
2.36
6.64
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
5.11
2-Sided
95
3.04
8.59
No
Superiority or Other
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Week 24
Title
Measurements
OG00067.7
OG00169.4
OG00245.8
Week 48
Title
Measurements
OG00059.9
OG00164.3
OG00235.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
2.60
2-Sided
95
1.63
4.13
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
2.85
2-Sided
95
1.79
4.54
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
2.93
2-Sided
95
1.83
4.67
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.33
2-Sided
95
2.08
5.32
No
Superiority or Other
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Week 24
Title
Measurements
OG00064.7
OG00167.7
OG00238.1
Week 48
Title
Measurements
OG00057.8
OG00163.0
OG00231.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.06
2-Sided
95
1.92
4.88
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.55
2-Sided
95
2.22
5.68
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.30
2-Sided
95
2.05
5.31
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.03
2-Sided
95
2.50
6.51
No
Superiority or Other
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Week 24
Title
Measurements
OG00042.2
OG00148.5
OG00224.6
Week 48
Title
Measurements
OG00041.8
OG00146.8
OG00216.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
0.0006
Odds Ratio (OR)
2.43
2-Sided
95
1.46
4.04
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.15
2-Sided
95
1.90
5.23
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.10
2-Sided
95
2.32
7.25
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.97
2-Sided
95
2.82
8.77
No
Superiority or Other
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000231
OG001235
OG002118
Title
Denominators
Categories
CD4
Title
Measurements
OG000187.5± 149.88
OG001176.5± 143.93
OG002178.5± 127.09
CD8
Title
Measurements
OG000941.1± 556.53
OG001880.1± 547.19
OG002880.4± 489.28
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000227
OG001233
OG002116
Title
Denominators
Categories
Week 24
Title
Measurements
OG000106.63± 7.255
OG001111.08± 7.148
OG00252.14± 10.140
Week 48
Title
Measurements
OG000112.53± 7.390
OG001122.44± 7.284
OG00253.97± 10.341
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
54.49
Standard Error of the Mean
12.435
2-Sided
95
30.07
78.92
No
Superiority or Other
OG001
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
58.94
Standard Error of the Mean
12.378
2-Sided
95
34.63
83.26
No
Superiority or Other
OG000
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
58.56
Standard Error of the Mean
12.677
2-Sided
95
33.66
83.46
No
Superiority or Other
OG001
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
68.47
Standard Error of the Mean
12.617
2-Sided
95
43.69
93.25
No
Superiority or Other
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000227
OG001233
OG002116
Title
Denominators
Categories
Week 24
Title
Measurements
OG000283.48± 30.206
OG001302.33± 29.745
OG002-0.74± 42.198
Week 48
Title
Measurements
OG000198.00± 28.962
OG001220.40± 28.532
OG002-15.34± 40.503
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
284.21
Standard Error of the Mean
51.779
2-Sided
95
182.51
385.92
No
Superiority or Other
OG001
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
303.07
Standard Error of the Mean
51.507
2-Sided
95
201.90
404.23
No
Superiority or Other
OG000
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
213.34
Standard Error of the Mean
49.679
2-Sided
95
115.77
310.92
No
Superiority or Other
OG001
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
235.74
Standard Error of the Mean
49.416
2-Sided
95
138.68
332.80
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Title
Measurements
OG000344.00(195.00 to 372.00)
OG001NA(NA to NA)Data was not estimable because less than 50% of participants experienced virological failure.
OG0020.00(NA to NA)Data was not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.
Log Rank
<0.0001
Hazard Ratio (HR)
0.45
2-Sided
95
0.34
0.60
No
Superiority or Other
OG001
OG002
P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.
Log Rank
<0.0001
Hazard Ratio (HR)
0.38
2-Sided
95
0.28
0.50
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Week 24
Title
Measurements
OG000-1.636± 0.0789
OG001-1.741± 0.0783
OG002-0.939± 0.1103
Week 48
Title
Measurements
OG000-1.556± 0.0876
OG001-1.720± 0.0870
OG002-0.788± 0.1227
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.697
Standard Error of the Mean
0.1347
2-Sided
95
-0.961
-0.432
No
Superiority or Other
OG001
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.802
Standard Error of the Mean
0.1344
2-Sided
95
-1.065
-0.538
No
Superiority or Other
OG000
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.767
Standard Error of the Mean
0.1497
2-Sided
95
-1.061
-0.474
No
Superiority or Other
OG001
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.931
Standard Error of the Mean
0.1494
2-Sided
95
-1.225
-0.638
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
Title
Measurements
OG000-1.656± 0.0949
OG001-1.824± 0.0942
OG002-0.803± 0.1329
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-0.853
Standard Error of the Mean
0.1621
2-Sided
97.5
-1.217
-0.489
No
Superiority or Other
OG001
OG002
The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-1.021
Standard Error of the Mean
0.1618
2-Sided
97.5
-1.385
-0.658
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000232
OG001235
OG002118
Title
Denominators
Categories
GSS: 0
Title
Measurements
OG00052
OG00159
OG00231
GSS: 1
Title
Measurements
OG00082
OG00180
OG00229
GSS: 2
Title
Measurements
OG00038
OG00148
OG00221
GSS: greater than or equal to 3
Title
Measurements
OG00057
OG00147
OG00234
GSS: missing
Title
Measurements
OG0003
OG0011
OG0023
PSS: 0
Title
Measurements
OG00025
OG00124
OG00217
PSS: 1
Title
Measurements
OG00070
OG00173
OG00218
PSS: 2
Title
Measurements
OG00051
OG00169
OG00235
PSS: greater than or equal to 3
Title
Measurements
OG00083
OG00166
OG00245
PSS: missing
Title
Measurements
OG0003
OG0013
OG0023
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00042
OG00146
OG00253
Title
Denominators
Categories
Change in GSS by less than -3 (n= 35 ,40, 47)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by -3 (n= 35 ,40, 47)
Title
Measurements
OG0000
OG0010
OG0020
Change in GSS by -2 (n= 35 ,40, 47)
Title
Measurements
OG0003
OG0010
OG0021
Change in GSS by -1 (n= 35 ,40, 47)
Title
Measurements
OG0009
OG00113
OG00211
Change in GSS by 0 (n= 35 ,40, 47)
Title
Measurements
OG00023
OG00126
OG00232
Change in GSS by 1 (n= 35 ,40, 47)
Title
Measurements
OG0000
OG0011
OG0021
Change in GSS by 2 (n= 35 ,40, 47)
Title
Measurements
OG0000
OG0010
OG0020
Change in GSS by 3 (n= 35 ,40, 47)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by greater than 3 (n= 35 ,40, 47)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by less than -3 (n= 35 ,40, 45)
Title
Measurements
OG0000
OG0010
OG0021
Change in PSS by -3 (n= 35 ,40, 45)
Title
Measurements
OG0004
OG0011
OG0021
Change in PSS by -2 (n= 35 ,40, 45)
Title
Measurements
OG0004
OG0011
OG0024
Change in PSS by -1 (n= 35 ,40, 45)
Title
Measurements
OG00010
OG00118
OG00212
Change in PSS by 0 (n= 35 ,40, 45)
Title
Measurements
OG00015
OG00117
OG00225
Change in PSS by 1 (n= 35 ,40, 45)
Title
Measurements
OG0002
OG0013
OG0022
Change in PSS by 2 (n= 35 ,40, 45)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by 3 (n= 35 ,40, 45)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by greater than 3 (n= 35 ,40, 45)
Title
Measurements
OG0000
OG0010
OG0020
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00051
OG00158
OG00262
Title
Denominators
Categories
Change in GSS by less than -3 (n= 44 ,52, 55)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by -3 (n= 44 ,52, 55)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by -2 (n= 44 ,52, 55)
Title
Measurements
OG0005
OG0011
OG0022
Change in GSS by -1 (n= 44 ,52, 55)
Title
Measurements
OG00012
OG00117
OG00215
Change in GSS by 0 (n= 44 ,52, 55)
Title
Measurements
OG00026
OG00131
OG00233
Change in GSS by 1 (n= 44 ,52, 55)
Title
Measurements
OG0001
OG0012
OG0021
Change in GSS by 2 (n= 44 ,52, 55)
Title
Measurements
OG0000
OG0011
OG0021
Change in GSS by 3 (n= 44 ,52, 55)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by greater than 3 (n= 44 ,52, 55)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by less than -3 (n= 44 , 52, 53)
Title
Measurements
OG0000
OG0011
OG0021
Change in PSS by -3 (n= 44 , 52, 53)
Title
Measurements
OG0004
OG0011
OG0023
Change in PSS by -2 (n= 44 , 52, 53)
Title
Measurements
OG0006
OG0013
OG0026
Change in PSS by -1 (n= 44 , 52, 53)
Title
Measurements
OG00013
OG00121
OG00212
Change in PSS by 0 (n= 44 , 52, 53)
Title
Measurements
OG00017
OG00123
OG00226
Change in PSS by 1 (n= 44 , 52, 53)
Title
Measurements
OG0003
OG0013
OG0024
Change in PSS by 2 (n= 44 , 52, 53)
Title
Measurements
OG0000
OG0010
OG0021
Change in PSS by 3 (n= 44 , 52, 53)
Title
Measurements
OG0001
OG0010
OG0020
Change in PSS by greater than 3 (n= 44 , 52, 53)
Title
Measurements
OG0000
OG0010
OG0020
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00042
OG00146
OG00253
Title
Denominators
Categories
Baseline: R5; Treatment failure: R5
Title
Measurements
OG00010
OG00110
OG00244
Baseline: R5; Treatment failure: X4
Title
Measurements
OG0006
OG0015
OG0020
Baseline: R5; Treatment failure: DM
Title
Measurements
OG00018
OG00119
OG0021
Baseline: R5; Treatment failure: NR/NP
Title
Measurements
OG0001
OG0013
OG0023
Baseline: DM; Treatment failure: R5
Title
Measurements
OG0000
OG0010
OG0021
Baseline: DM; Treatment failure: X4
Title
Measurements
OG0001
OG0014
OG0021
Baseline: DM; Treatment failure: DM
Title
Measurements
OG0003
OG0014
OG0021
Baseline: DM; Treatment failure: NR/NP
Title
Measurements
OG0001
OG0011
OG0020
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00051
OG00158
OG00262
Title
Denominators
Categories
Baseline: R5, Treatment failure: R5
Title
Measurements
OG00016
OG00115
OG00249
Baseline: R5, Treatment failure: X4
Title
Measurements
OG0006
OG0017
OG0020
Baseline: R5, Treatment failure: DM
Title
Measurements
OG00019
OG00122
OG0023
Baseline: R5, Treatment failure: NR/NP
Title
Measurements
OG0001
OG0013
OG0023
Baseline: DM, Treatment failure: R5
Title
Measurements
OG0000
OG0010
OG0022
Baseline: DM, Treatment failure: X4
Title
Measurements
OG0002
OG0014
OG0021
Baseline: DM, Treatment failure: DM
Title
Measurements
OG0004
OG0015
OG0021
Baseline: DM, Treatment failure: NR/NP
Title
Measurements
OG0002
OG0011
OG0020
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).