Safety and Efficacy of a Switch to Doravirine, Tenofovir,... | NCT02397096 | Trialant
NCT02397096
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 20, 2024Actual
Enrollment
673Actual
Phase
Phase 3
Conditions
HIV-1 Infection
Interventions
Doravirine, Tenofovir, Lamivudine
Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor
Baseline regimen of cobicistat-boosted elvitegravir
Baseline regimen of a non-nucleoside reverse transcriptase inhibitor
Baseline regimen of two nucleoside reverse transcriptase inhibitors
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02397096
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1439A-024
Secondary IDs
ID
Type
Description
Link
MK-1439A-024
Other Identifier
MSD ID
2014-005550-18
EudraCT Number
Brief Title
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
Official Title
A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Acronym
DRIVE-SHIFT
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 2024
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
Jun 9, 2015Actual
Primary Completion Date
Feb 22, 2018Actual
Completion Date
Sep 5, 2023Actual
First Submitted Date
Mar 18, 2015
First Submission Date that Met QC Criteria
Mar 18, 2015
First Posted Date
Mar 24, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 4, 2019
Results First Submitted that Met QC Criteria
Mar 13, 2019
Results First Posted Date
Apr 3, 2019Actual
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
Nov 4, 2024
Last Update Posted Date
Nov 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to doravirine, tenofovir, lamivudine will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study results will be based on the first 48 weeks of this ongoing study.
Detailed Description
Three optional study extensions are planned. Study Extension 1 will evaluate safety of the switch to doravirine, tenofovir, lamivudine for an additional 2 years beyond the Base Study. Study Extensions 2 and 3 will evaluate safety of the switch to doravirine, tenofovir, lamivudine until doravirine, tenofovir, lamivudine becomes locally available, or 4 years beyond Study Extension 1, whichever comes first.
Conditions Module
Conditions
HIV-1 Infection
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
673Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Experimental
Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to doravirine, tenofovir, lamivudine single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions
Drug: Doravirine, Tenofovir, Lamivudine
Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor
Drug: Baseline regimen of cobicistat-boosted elvitegravir
Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor
Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitors
Delayed Switch to Doravirine, Tenofovir, Lamivudine
Active Comparator
Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to doravirine, tenofovir, lamivudine single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions
Drug: Doravirine, Tenofovir, Lamivudine
Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor
Drug: Baseline regimen of cobicistat-boosted elvitegravir
Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor
Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitors
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Doravirine, Tenofovir, Lamivudine
Drug
Single tablet containing MK-1439 (doravirine) 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg
Delayed Switch to Doravirine, Tenofovir, Lamivudine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
Have plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) levels below the limit of quantification (BLoQ) (<40 copies/mL by the Abbott RealTime HIV-1 Assay as determined by the central laboratory) at the screening visit.
Receiving antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 Nucleoside Reverse Transcriptase Inhibitor (NRTIs) (and no other antiretroviral therapy) continuously for >= 6 months.
Receiving first or second retroviral regimen (participants receiving a NNRTI at Screening must be on their first retroviral regimen)
No history of using an experimental NNRTI
Has a genotype prior to starting his/her initial antiretroviral regimen and no known resistance to any of the study agents
Not receiving lipid lowering therapy or on a stable dose of lipid lowering therapy at the time of enrollment
Has the following laboratory values at screening within 30 days prior to the treatment phase of this study: Alkaline phosphatase ≤ 3.0 x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 5.0 x ULN, and Hemoglobin ≥9.0 g/dL (if female) or ≥10.0 g/dL (if male)
Has a calculated creatinine clearance at the time of screening ≥ 50 mL/min, based on the Cockcroft-Gault equation
Male or female participant not of reproductive potential or, if of reproductive potential, agrees to avoid becoming pregnant or impregnating a partner while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: 1) practice abstinence from heterosexual activity, or 2) use acceptable contraception during heterosexual activity
For inclusion in Study Extension 1 (optional): completed the Week 48 visit; considered to have derived benefit from study participation up to Week 48; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
For inclusion in Study Extension 2 (optional): completed the Week 144 visit; considered to have derived benefit from study participation up to Week 144; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
For inclusion in Study Extension 3 (optional): completed the Week 240 visit; considered to have derived benefit from study participation up to Week 240; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
Exclusion Criteria:
Exclusion Criteria include, but are not limited to:
Uses recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence
Received treatment for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 such as adefovir, emtricitabine, lamivudine, or tenofovir
Has documented or known resistance to study drugs including doravirine, lamivudine, and/or tenofovir
Participated in a study with an investigational compound or device within 30 days or anticipates doing so during the course of this study
Used systemic immunosuppressive therapy or immune modulators within 30 days or anticipates needing them during the course of this study (short courses of corticosteroids will be allowed)
Current, active diagnosis of acute hepatitis due to any cause (participants with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic function)
Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte score >9
Pregnant, breastfeeding, or expecting to conceive at any time during the study
Female and is expecting to donate eggs or male and is expecting to donate sperm during the study
Orkin C, Koethe JR, Kumar PN, Sklar P, Xu ZJ, Plank RM, Greaves W, Lahoulou R. Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen. Open Forum Infect Dis. 2025 Nov 20;12(11):ofaf639. doi: 10.1093/ofid/ofaf639. eCollection 2025 Nov.
Walmsley SL, Kumar PN, Orkin C, Thompson M, Squires K, Xu ZJ, Greaves W, Plank RM, Whiteside Y, Lahoulou R. Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials. Open Forum Infect Dis. 2025 Jul 16;12(7):ofaf356. doi: 10.1093/ofid/ofaf356. eCollection 2025 Jul.
Out of 852 participants screened, 673 were randomized to study treatment, and 670 were treated. There were 122 global study sites utilized.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Periods
Title
Milestones
Reasons Not Completed
Day 1 to Week 24
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 31, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Australia
Austria
Belgium
Canada
Colombia
Denmark
France
Germany
Guatemala
Israel
Italy
Mexico
New Zealand
Peru
Poland
Puerto Rico
Russia
South Korea
Spain
Switzerland
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor
Drug
Baseline regimen of antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) administered according to the product circular
Delayed Switch to Doravirine, Tenofovir, Lamivudine
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of cobicistat-boosted elvitegravir
Drug
Baseline regimen of antiretroviral therapy with cobicistat-boosted elvitegravir administered according to the product circular
Delayed Switch to Doravirine, Tenofovir, Lamivudine
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of a non-nucleoside reverse transcriptase inhibitor
Drug
Baseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular
Delayed Switch to Doravirine, Tenofovir, Lamivudine
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of two nucleoside reverse transcriptase inhibitors
Drug
Baseline regimen of antiretroviral therapy with two NRTIs administered according to the product circular
Delayed Switch to Doravirine, Tenofovir, Lamivudine
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline and Week 24
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy.
Baseline and Week 24
Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Week 24
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Baseline and Week 24
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups.
Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants With HIV-1 RNA >=50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach.
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Up to week 24
Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed.
Up to 24 weeks
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Vaddady P, Kandala B, Yee KL. Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00590-20. doi: 10.1128/AAC.00590-20. Print 2020 Oct 20.
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
FG000450 subjects
FG001223 subjects
Treated
FG000447 subjects
FG001223 subjects
COMPLETED
FG000427 subjects
FG001209 subjects
NOT COMPLETED
FG00023 subjects
FG00114 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0011 subjects
Death
FG0001 subjects
FG0010 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
Lost to Follow-up
FG0003 subjects
FG0014 subjects
Physician Decision
FG0002 subjects
FG0013 subjects
Protocol Violation
FG0001 subjects
FG0014 subjects
Withdrawal by Subject
FG0006 subjects
FG0011 subjects
Randomized, not treated
FG0003 subjects
FG0010 subjects
Week 24 to Week 48
Type
Comment
Milestone Data
STARTED
FG000427 subjects
FG001209 subjects
COMPLETED
FG000407 subjects
FG001202 subjects
NOT COMPLETED
FG00020 subjects
FG0017 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0012 subjects
Lack of Efficacy
FG0005 subjects
FG001
Study Extension 1
Type
Comment
Milestone Data
STARTED
FG000398 subjectsNumber started refers only to participants completing Base Study volunteering to continue to Study Extension Part 1.
FG001202 subjects
COMPLETED
FG000357 subjects
FG001179 subjects
NOT COMPLETED
FG00041 subjects
FG00123 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0015 subjects
Death
FG0001 subjects
FG001
Study Extension 2
Type
Comment
Milestone Data
STARTED
FG000303 subjectsNumber started refers only to participants completing Base Study and Study Extension Part 1 and volunteering to continue to Study Extension Part 2.
FG001154 subjectsNumber started refers only to participants completing Base Study and Study Extension Part 1 and volunteering to continue to Study Extension Part 2.
COMPLETED
FG000129 subjects
FG00178 subjects
NOT COMPLETED
FG000174 subjects
FG00176 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0013 subjects
Availability of study medication locally
FG000152 subjects
FG001
Study Extension 3
Type
Comment
Milestone Data
STARTED
FG00084 subjectsNumber started refers only to participants completing Base Study, Study Extension Part 1, Study Extension Part 2 and volunteering to continue to Study Extension Part 3.
FG00143 subjectsNumber started refers only to participants completing Base Study, Study Extension Part 1, Study Extension Part 2 and volunteering to continue to Study Extension Part 3.
COMPLETED
FG00069 subjects
FG00139 subjects
NOT COMPLETED
FG00015 subjects
FG0014 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
Availability of study medication locally
FG00011 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
BG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000450
BG001223
BG002673
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00043.1± 10.1
BG00143.7± 10.6
BG00243.3± 10.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00075
BG00129
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00098
BG00143
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0005
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Units
Counts
Participants
OG000447
OG001223
Title
Denominators
Categories
Title
Measurements
OG00090.8
OG00194.6
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
OG001
Treatment Difference
-3.784
2-Sided
95
-7.877
0.310
Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.
Non-Inferiority
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.
Secondary
Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
All randomized participants in the ritonavir-boosted PI-based regimen who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
Posted
Mean
Standard Deviation
mg/dL
Baseline and Week 24
ID
Title
Description
OG000
Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir-boosted, PI-based regimen for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir-boosted, PI-based regimen for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy.
All randomized participants who received the ritonavir-boosted PI-based regimen at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
Posted
Mean
Standard Deviation
mg/dL
Baseline and Week 24
ID
Title
Description
OG000
Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)
Participants receiving continuous antiretroviral therapy with a ritonavir-boosted, PI-based regimen for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)
Participants receiving continuous antiretroviral therapy with a ritonavir-boosted, PI-based regimen for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
All randomized participants who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
Posted
Mean
Standard Deviation
cells/mm^3
Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Secondary
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
All randomized participants who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
Posted
Geometric Mean
Standard Deviation
cells/mm^3
Baseline and Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants With HIV-1 RNA >=50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Up to week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Up to 24 weeks
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Secondary
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
All randomized participants who received at least 1 dose of study drug.
Posted
Number
Percentage of Participants
Up to Week 24
ID
Title
Description
OG000
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
OG001
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Time Frame
Up to ~338 weeks
Description
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
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
ISG Base Study Weeks 0-24
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
1
450
13
447
100
447
EG001
DSG Base Study Weeks 0-24
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
223
8
223
28
223
EG002
ISG Base Study Weeks 24-48
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
427
11
427
63
427
EG003
DSG Base Study Weeks 24-48
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
209
4
209
33
209
EG004
ISG Study Extension 1
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
1
398
37
398
107
398
EG005
DSG Study Extension 1
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
202
13
202
57
202
EG006
ISG Study Extension 2
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
3
303
13
303
24
303
EG007
DSG Study Extension 2
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
154
7
154
11
154
EG008
ISG Study Extension 3
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for >=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
84
3
84
9
84
EG009
DSG Study Extension 3
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
0
43
1
43
3
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG0030 events0 affected209 at risk
EG0040 events0 affected398 at risk
EG0050 events0 affected202 at risk
EG0061 events1 affected303 at risk
EG0070 events0 affected154 at risk
EG0080 events0 affected84 at risk
EG0090 events0 affected43 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Distal intestinal obstruction syndrome
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Haemoperitoneum
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Oesophageal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Muscle abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0013 events3 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Shigella infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Syphilis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Tuberculous pleurisy
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Amylase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
CD4 lymphocytes decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Lipase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Burkitt's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Epstein-Barr virus associated lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Amyotrophic lateral sclerosis
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Behaviour disorder
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0021 events1 affected427 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0011 events1 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Obstructive sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Ischaemia
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00021 events20 affected447 at risk
EG0015 events5 affected223 at risk
EG00213 events13 affected427 at risk
EG00310 events9 affected209 at risk
EG00420 events18 affected398 at risk
EG00514 events11 affected202 at risk
EG0063 events3 affected303 at risk
EG0070 events0 affected154 at risk
EG0081 events1 affected84 at risk
EG0090 events0 affected43 at risk
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected447 at risk
EG0010 events0 affected223 at risk
EG0020 events0 affected427 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00034 events33 affected447 at risk
EG00114 events12 affected223 at risk
EG00221 events19 affected427 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG00014 events14 affected447 at risk
EG0015 events5 affected223 at risk
EG0029 events8 affected427 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0009 events9 affected447 at risk
EG0014 events4 affected223 at risk
EG00216 events16 affected427 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00032 events29 affected447 at risk
EG0015 events5 affected223 at risk
EG00211 events11 affected427 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
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).
Units
Counts
Participants
OG000256
OG001125
Title
Denominators
Categories
Baseline
Title
Measurements
OG000108.82± 34.21
OG001109.00± 33.58
Change from Baseline
Title
Measurements
OG000-16.54± 23.10
OG001-1.94± 25.74
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
OG001
ANCOVA
<0.0001
Treatment Difference
-14.65
2-Sided
95
-18.92
-10.38
95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.
Other
Units
Counts
Participants
OG000266
OG001133
Title
Denominators
Categories
Baseline
Title
Measurements
OG000139.14± 42.12
OG001137.99± 38.46
Change from Baseline
Title
Measurements
OG000-24.74± 29.26
OG001-1.31± 28.45
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
OG001
ANCOVA
<0.0001
Treatment Difference
-23.03
2-Sided
95
-28.00
-18.05
95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.
Other
Units
Counts
Participants
OG000447
OG001223
Title
Denominators
Categories
Title
Measurements
OG00093.7
OG00194.6
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
OG001
Treatment Difference
-0.877
2-Sided
95
-4.706
2.952
Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.
Non-Inferiority
DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.
Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
Units
Counts
Participants
OG000402
OG001209
Title
Denominators
Categories
Baseline
Title
Measurements
OG000660.5± 293.4
OG001655.6± 279.3
Change from Baseline
Title
Measurements
OG00013.9± 168.1
OG00118.0± 157.7
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
OG001
Mean Difference (Final Values)
-4.0
2-Sided
95
-31.6
23.5
95% CIs were calculated based on t-distribution.
Other
Units
Counts
Participants
OG000412
OG001209
Title
Denominators
Categories
Baseline
Title
Measurements
OG000664.5± 300.7
OG001655.6± 279.3
Change from Baseline
Title
Measurements
OG0005.1± 174.9
OG00118.0± 157.7
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
OG001
Mean Difference (Final Values)
-12.8
2-Sided
95
-41.1
15.4
95% Confidence Intervals were based on t-distribution.
Superiority
Units
Counts
Participants
OG000447
OG001223
Title
Denominators
Categories
Title
Measurements
OG00089.7
OG00193.3
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
OG001
Treatment Difference
-3.556
2-Sided
95
-7.977
0.864
Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.
Other
Units
Counts
Participants
OG000447
OG001223
Title
Denominators
Categories
Title
Measurements
OG00092.8
OG00193.3
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
OG001
Treatment Difference
-0.427
2-Sided
95
-4.591
3.738
Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.
Other
Units
Counts
Participants
OG000447
OG001223
Title
Denominators
Categories
Title
Measurements
OG0001.6
OG0011.8
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
OG001
Treatment Difference
-0.232
2-Sided
95
-2.529
2.064
Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.
Non-Inferiority
DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.