Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A... | NCT02403674 | Trialant
NCT02403674
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 20, 2024Actual
Enrollment
734Actual
Phase
Phase 3
Conditions
Human Immunodeficiency Virus (HIV)
Interventions
Doravirine, Tenofovir, Lamivudine
ATRIPLAâ„¢
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02403674
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1439A-021
Secondary IDs
ID
Type
Description
Link
MK-1439A-021
Other Identifier
MSD Protocol Number
2014-003382-17
EudraCT Number
Brief Title
Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLAâ„¢ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
Official Title
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
Acronym
DRIVE-AHEAD
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 5, 2015Actual
Primary Completion Date
Mar 20, 2017Actual
Completion Date
Sep 7, 2023Actual
First Submitted Date
Mar 26, 2015
First Submission Date that Met QC Criteria
Mar 26, 2015
First Posted Date
Mar 31, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 8, 2018
Results First Submitted that Met QC Criteria
Mar 28, 2018
Results First Posted Date
Apr 30, 2018Actual
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)
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
The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439A) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLAâ„¢, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLAâ„¢ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. This study has a total duration of 384 weeks, including a 96-week double-blind period and an additional 288-week open-label period.
Detailed Description
Participants in Australia, Colombia, Guatemala, Honduras, Israel, New Zealand, Peru, Russia, South Africa, and Thailand who are deriving benefit from doravirine, tenofovir, lamivudine are also eligible to continue receiving study drug during additional open-label extensions which will last for 2 years or until drug is available locally, whichever comes first.
Conditions Module
Conditions
Human Immunodeficiency Virus (HIV)
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
734Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Doravirine, Tenofovir, Lamivudine
Experimental
Treatment-naive HIV-infected participants will receive doravirine, tenofovir, lamivudine, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding.
Drug: Doravirine, Tenofovir, Lamivudine
Drug: Placebo
ATRIPLAâ„¢
Active Comparator
Treatment-naive HIV-infected participants will receive ATRIPLAâ„¢, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to doravirine, tenofovir, lamivudine q.d. by mouth for 96 weeks in order to maintain blinding.
Drug: ATRIPLAâ„¢
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Doravirine, Tenofovir, Lamivudine
Drug
One doravirine, tenofovir, lamivudine tablet taken q.d. by mouth.
Doravirine, Tenofovir, Lamivudine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 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 in which all missing data are considered treatment failures, regardless of the reason.
Week 48
Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included "dizziness", "sleep disorders and disturbances", and "altered sensorium" (including disturbance in attention).
Up to Week 48
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 96 were determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) were used for efficacy analyses.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is HIV-1 positive as determined by a positive result on an enzyme-immunoassay, has screening plasma HIV-1 RNA (determined by the central laboratory) ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and has HIV treatment indicated based on physician assessment
Has never received antiretroviral therapy (ART)
Is highly unlikely to either become pregnant or impregnate a partner
Exclusion Criteria:
Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study
Is a user of recreational or illicit drugs or has a recent history of alcohol/drug abuse
Has been treated for a viral infection other than HIV-1 (e.g., hepatitis B) with an agent that is active against HIV-1
Has participated in a study with an investigational drug/device within 30 days prior to Screening
Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
Has a current (active) diagnosis of acute hepatitis due to any cause (note: 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 synthetic function)
Is a female who is pregnant, breastfeeding, or expecting to conceive
Is a female and is expecting to donate eggs or is male and is expecting to donate sperm (investigators will provide appropriate guidance regarding egg and/or sperm donation after completion of the study treatment regimen)
Has evidence of decompensated liver disease manifested by the presence of or a history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver diseases, or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9
Molina JM, Orkin C, Paredes R, Xu ZJ, Su FH, Asante-Appiah E, Plank RM, Lahoulou R. Analysis of Viral Blips Through Week 192 of the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Studies of Doravirine-Based Regimens in Adults Living With Previously Untreated HIV-1. Open Forum Infect Dis. 2026 Jun 10;13(6):ofag258. doi: 10.1093/ofid/ofag258. eCollection 2026 Jun.
Treatment-naïve participants with HIV-1 infection have been recruited at 141 study sites worldwide. The present results include results from the base study (first 96-weeks of the study) along with study extension 1 (week 96-192), study extension 2 (week 192-288), and study extension 3 (week 288-384).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Periods
Title
Milestones
Reasons Not Completed
Base Study
Type
Comment
Milestone Data
STARTED
Randomized
Baseline Characteristics Module
Baseline Analysis Population Description
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
Nov 2, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Belgium
Canada
Chile
Colombia
Denmark
Germany
Guatemala
Honduras
Israel
Mexico
Netherlands
New Zealand
Peru
Portugal
Puerto Rico
Russia
South Africa
Spain
Switzerland
Taiwan
Thailand
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
MK-1439A
ATRIPLAâ„¢
Drug
One ATRIPLAâ„¢ tablet taken q.d. by mouth
ATRIPLAâ„¢
Placebo
Drug
Placebo tablets matched to ATRIPLA® or Doravirine, Tenofovir, Lamivudine.
ATRIPLAâ„¢
Doravirine, Tenofovir, Lamivudine
Week 96
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV 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 in which all missing data are considered treatment failures, regardless of the reason.
Week 48
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 96 were determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) were used for efficacy analyses.
Week 96
Change From Baseline in CD4 Cell Counts at Week 48
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 prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Baseline (Day 1) and Week 48
Change From Baseline in CD4 Cell Counts at Week 96
The mean change from baseline in CD4 cell counts at Week 96 were assessed using the OF approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 were measured and expressed as cells/mm^3, and percent change was calculated as [(Baseline counts - Week 96 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Baseline (Day 1) and Week 96
Percentage of Participants Experiencing ≥1 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 48
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.
Up to Week 48
Percentage of Participants With Tier-2 Neuropsychiatric AEs
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included "depression and suicide/self-injury" and "psychosis and psychotic disorders".
Up to Week 48
Change From Baseline in Fasting LDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Baseline (Day 1) and Week 48
Change From Baseline in Fasting Non-HDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Baseline (Day 1) and Week 48
Change From Baseline in Fasting Cholesterol at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Baseline (Day 1) and Week 48
Change From Baseline in Fasting Triglycerides at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Baseline (Day 1) and Week 48
Change From Baseline in Fasting HDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Baseline (Day 1) and Week 48
Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.
Week 48
Percentage of Participants With HIV-1 RNA BLoQ at Week 96
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 was determined. Plasma HIV RNA levels was quantified with the Abbott RealTime HIV-1 Assay. Data was handled as observed.
Week 96
Plasma Concentration of Doravirine at Week 48
Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.
0 hours post-dose and 2 hours post-dose on Week 48
Derived
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.
Hsue PY, Behrens GMN, Xu ZJ, Zhao Y, Cmar J, Lahoulou R, Campo RE, Plank RM. Cardiovascular Risk Assessment Using the Atherosclerotic Cardiovascular Disease Risk Score Model after Continuing or Switching to a Doravirine-Based HIV Treatment Regimen. J Acquir Immune Defic Syndr. 2026 Feb 1;101(2):208-213. doi: 10.1097/QAI.0000000000003778.
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.
Moyle G, Meng F, Wan H, Sklar P, Plank RM, Lahoulou R. Brief Report: Resolution of Neuropsychiatric Adverse Events After Switching to a Doravirine-Based Regimen in the Open-Label Extensions of the DRIVE-AHEAD and DRIVE-FORWARD Trials. J Acquir Immune Defic Syndr. 2025 May 1;99(1):81-86. doi: 10.1097/QAI.0000000000003599.
Orkin C, Molina JM, Cahn P, Lombaard J, Supparatpinyo K, Kumar S, Campbell H, Wan H, Teal V, Jin Xu Z, Asante-Appiah E, Sklar P, Teppler H, Lahoulou R; DRIVE-FORWARD and DRIVE-AHEAD collaborators. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. Lancet HIV. 2024 Feb;11(2):e75-e85. doi: 10.1016/S2352-3018(23)00258-8. Epub 2023 Dec 20.
Orkin C, Squires KE, Molina JM, Sax PE, Sussmann O, Lin G, Kumar S, Hanna GJ, Hwang C, Martin E, Teppler H. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial. Clin Infect Dis. 2021 Jul 1;73(1):33-42. doi: 10.1093/cid/ciaa822.
Orkin C, Molina JM, Lombaard J, DeJesus E, Rodgers A, Kumar S, Martin E, Hanna G, Hwang C. Once-daily Doravirine in Human Immunodeficiency Virus Type 1-Infected, Antiretroviral-naive Adults: An Integrated Efficacy Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1344-1352. doi: 10.1093/cid/ciz424.
Thompson M, Orkin C, Molina JM, Sax P, Cahn P, Squires K, Xu X, Rodgers A, Kumar S, Teppler H, Martin E, Hanna G, Hwang C. Once-daily Doravirine for Initial Treatment of Adults Living With Human Immunodeficiency Virus-1: An Integrated Safety Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1336-1343. doi: 10.1093/cid/ciz423.
Orkin C, Squires KE, Molina JM, Sax PE, Wong WW, Sussmann O, Kaplan R, Lupinacci L, Rodgers A, Xu X, Lin G, Kumar S, Sklar P, Nguyen BY, Hanna GJ, Hwang C, Martin EA; DRIVE-AHEAD Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Clin Infect Dis. 2019 Feb 1;68(4):535-544. doi: 10.1093/cid/ciy540.
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
FG000368 subjects
FG001366 subjects
Treated
Received ≥1 dose of study medication.
FG000364 subjects
FG001364 subjects
COMPLETED
Completed through Week 96
FG000296 subjects
FG001276 subjects
NOT COMPLETED
FG00072 subjects
FG00190 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0014 subjects
Adverse Event
FG00011 subjects
FG00126 subjects
Lack of Efficacy
FG00031 subjects
FG00123 subjects
Lost to Follow-up
FG0006 subjects
FG0018 subjects
Withdrawal by Subject
FG00010 subjects
FG00117 subjects
Physician Decision
FG0002 subjects
FG0012 subjects
Pregnancy
FG0002 subjects
FG0012 subjects
Protocol Violation
FG0008 subjects
FG0014 subjects
Non-Compliance with study drug
FG0001 subjects
FG0014 subjects
Study Extension 1 (Open-Label)
Type
Comment
Milestone Data
STARTED
Not all study participants continued into optional study extension 1
FG000291 subjects
FG001269 subjects
COMPLETED
FG000230 subjects
FG001205 subjects
NOT COMPLETED
FG00061 subjects
FG00164 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0014 subjects
Lack of Efficacy
FG00010 subjects
FG001
Study Extension 2 (Open-Label)
Type
Comment
Milestone Data
STARTED
Not all study participants continued into optional study extension 2
FG000192 subjects
FG001173 subjects
COMPLETED
FG000150 subjects
FG001132 subjects
NOT COMPLETED
FG00042 subjects
FG00141 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0001 subjects
FG0011 subjects
Lost to Follow-up
FG0001 subjects
FG001
Study Extension 3 (Open-Label)
Type
Comment
Milestone Data
STARTED
Not all study participants continued into optional study extension 3
FG000121 subjects
FG001111 subjects
COMPLETED
FG000100 subjects
FG00185 subjects
NOT COMPLETED
FG00021 subjects
FG00126 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0005 subjects
FG0014 subjects
Withdrawal by Subject
FG0001 subjects
FG001
The Baseline Analysis Population consists of all randomized participants who received ≥1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
BG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000364
BG001364
BG002728
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
ParticipantsBG000364
ParticipantsBG001364
ParticipantsBG002728
Title
Measurements
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000364
ParticipantsBG001364
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000364
ParticipantsBG001364
ParticipantsBG002
Baseline cluster of differentiation 4 (CD4) cell counts
Participants fasted for ≥8 hours prior to HDL-C measurement on Day 1.
All randomized participants with baseline data available.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
ParticipantsBG000357
ParticipantsBG001357
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 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 in which all missing data are considered treatment failures, regardless of the reason.
The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Title
Measurements
OG00084.3
OG00180.8
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
Difference in percentages
3.537
2-Sided
95
-1.951
9.026
The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).
Non-Inferiority
Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.
Primary
Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included "dizziness", "sleep disorders and disturbances", and "altered sensorium" (including disturbance in attention).
The analysis population consists of all randomized participants who received ≥1 dose of study medication.
Posted
Number
Percentage of Participants
Up to Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 96 were determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) were used for efficacy analyses.
The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 96
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Secondary
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV 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 in which all missing data are considered treatment failures, regardless of the reason.
The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Secondary
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 96 were determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) were used for efficacy analyses.
The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 96
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Secondary
Change From Baseline in CD4 Cell Counts at Week 48
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 prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and Week 48 CD4 data available.
Posted
Mean
95% Confidence Interval
Percent Change from Baseline
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
Secondary
Change From Baseline in CD4 Cell Counts at Week 96
The mean change from baseline in CD4 cell counts at Week 96 were assessed using the OF approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 were measured and expressed as cells/mm^3, and percent change was calculated as [(Baseline counts - Week 96 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and week 96 CD4 data available.
Posted
Mean
95% Confidence Interval
Percentage Change from Baseline
Baseline (Day 1) and Week 96
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Secondary
Percentage of Participants Experiencing ≥1 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.
The analysis population consisted of all randomized participants who received ≥1 dose of study medication.
Posted
Number
Percentage of participants
Up to Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
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.
The analysis population consisted of all randomized participants who received ≥1 dose of study medication.
Posted
Number
Percentage of participants
Up to Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Percentage of Participants With Tier-2 Neuropsychiatric AEs
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included "depression and suicide/self-injury" and "psychosis and psychotic disorders".
The analysis population consists of all randomized participants who received ≥1 dose of study medication.
Posted
Number
Percentage of Participants
Up to Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Change From Baseline in Fasting LDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
The analysis population consists of all randomized participants who had baseline LDL-C data available as well as ≥1 LDL-C measurement after initiating study treatment.
Posted
Mean
95% Confidence Interval
Percent Change from Baseline
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Change From Baseline in Fasting Non-HDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
The analysis population consists of all randomized participants who had baseline non-HDL-C data available as well as ≥1 non-HDL-C measurement after initiating study treatment.
Posted
Mean
95% Confidence Interval
Percent Change from Baseline
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Change From Baseline in Fasting Cholesterol at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
The analysis population consists of all randomized participants who had baseline cholesterol data available as well as ≥1 cholesterol measurement after initiating study treatment.
Posted
Mean
95% Confidence Interval
Percent Change from Baseline
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Change From Baseline in Fasting Triglycerides at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
The analysis population consists of all randomized participants who had baseline triglyceride data available as well as ≥1 triglyceride measurement after initiating study treatment.
Posted
Mean
95% Confidence Interval
Percent Change from Baseline
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Change From Baseline in Fasting HDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
The analysis population consists of all randomized participants who had baseline HDL-C data available as well as ≥1 HDL-C measurement after initiating study treatment.
Posted
Mean
95% Confidence Interval
Percent Change from Baseline
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.
The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Percentage of Participants With HIV-1 RNA BLoQ at Week 96
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 was determined. Plasma HIV RNA levels was quantified with the Abbott RealTime HIV-1 Assay. Data was handled as observed.
The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Posted
Number
Percentage of Participants
Week 96
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
OG001
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Secondary
Plasma Concentration of Doravirine at Week 48
Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.
The analysis population consists of all randomized participants in the MK-1439A arm who received ≥1 dose of study drug and had doravirine concentration data available.
Posted
Mean
Standard Deviation
nM
0 hours post-dose and 2 hours post-dose on Week 48
ID
Title
Description
OG000
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLAâ„¢ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
Time Frame
Up to 430 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. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
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
DOR/3TC/TDF Only (From Day 1) at Base Study
Treatment-naive participants took a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for a total of 96 weeks.
1
368
22
364
231
364
EG001
DOR/3TC/TDF Switch at Week 96 Base Study
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for a total of 96 weeks.
4
366
30
364
281
364
EG002
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 1
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 96 - Week 192)
2
291
19
291
111
291
EG003
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 1
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 96 - Week 192)
0
269
12
269
110
269
EG004
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 2
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 192 - Week 288)
2
192
8
192
0
0
EG005
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 2
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 192 - Week 288)
2
173
9
173
0
0
EG006
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 3
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 388 - Week 384)
0
121
2
121
0
0
EG007
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 3
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 388 - Week 384)
0
111
7
111
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG0030 events0 affected269 at risk
EG0040 events0 affected192 at risk
EG0050 events0 affected173 at risk
EG0060 events0 affected121 at risk
EG0070 events0 affected111 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Thyroid cyst
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Death
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Anal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Endometritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Lymphadenitis bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Oophoritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Oral bacterial infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Pilonidal disease
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Anal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0004 events2 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0012 events2 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Neurofibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0023 events1 affected291 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Lipodystrophy acquired
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected364 at risk
EG0010 events0 affected364 at risk
EG0023 events1 affected291 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Malignant hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0011 events1 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Toxic nodular goitre
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Proctitis ulcerative
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Orchitis mumps
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0022 events2 affected291 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Leiomyosarcoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Acute hepatitis C
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Poisoning
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Myopericarditis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0021 events1 affected291 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Anaplastic large-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Mania
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected364 at risk
EG0010 events0 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00073 events50 affected364 at risk
EG00168 events58 affected364 at risk
EG00221 events16 affected291 at risk
EG00318 events17 affected269 at risk
EG0040 events0 affected0 at risk
EG0050 events0 affected0 at risk
EG0060 events0 affected0 at risk
EG0070 events0 affected0 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00035 events31 affected364 at risk
EG00155 events42 affected364 at risk
EG0025 events5 affected291 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00023 events19 affected364 at risk
EG00142 events29 affected364 at risk
EG0023 events1 affected291 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG00025 events22 affected364 at risk
EG00126 events24 affected364 at risk
EG0024 events4 affected291 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00089 events50 affected364 at risk
EG00161 events43 affected364 at risk
EG00258 events40 affected291 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00039 events30 affected364 at risk
EG00127 events20 affected364 at risk
EG00216 events13 affected291 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00055 events41 affected364 at risk
EG00140 events30 affected364 at risk
EG00233 events21 affected291 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00023 events18 affected364 at risk
EG00121 events19 affected364 at risk
EG0027 events7 affected291 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00047 events37 affected364 at risk
EG001155 events139 affected364 at risk
EG0022 events2 affected291 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00096 events58 affected364 at risk
EG00177 events56 affected364 at risk
EG00219 events18 affected291 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00013 events13 affected364 at risk
EG00128 events28 affected364 at risk
EG0022 events2 affected291 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00020 events18 affected364 at risk
EG00149 events44 affected364 at risk
EG0020 events0 affected291 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00035 events24 affected364 at risk
EG00142 events38 affected364 at risk
EG0027 events6 affected291 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00025 events22 affected364 at risk
EG00124 events20 affected364 at risk
EG0028 events8 affected291 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00022 events20 affected364 at risk
EG00154 events50 affected364 at risk
EG0029 events8 affected291 at risk
EG003
Syphilis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00021 events18 affected364 at risk
EG00115 events14 affected364 at risk
EG00218 events16 affected291 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 trial 45 days prior to submission for publication/presentation.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Ancestor Terms
ID
Term
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D009930
Organic Chemicals
D000225
Adenine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D016047
Zalcitabine
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D015224
Dideoxynucleosides
D010078
Oxazines
D000068679
Emtricitabine
D004338
Drug Combinations
D004364
Pharmaceutical Preparations
Browse Leaves
Not provided
Browse Branches
Not provided
13 subjects
Lost to Follow-up
FG0008 subjects
FG0015 subjects
Withdrawal by Subject
FG00011 subjects
FG00113 subjects
Physician Decision
FG0002 subjects
FG0015 subjects
Pregnancy
FG0004 subjects
FG0012 subjects
Death
FG0001 subjects
FG0010 subjects
Availability of study drug locally
FG00022 subjects
FG00119 subjects
Non-Compliance
FG0002 subjects
FG0013 subjects
7 subjects
Withdrawal by Subject
FG0008 subjects
FG0016 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
Death
FG0002 subjects
FG0012 subjects
Availability of study drug locally
FG00027 subjects
FG00123 subjects
Non-Compliance with study drug
FG0002 subjects
FG0010 subjects
3 subjects
Physician Decision
FG0001 subjects
FG0015 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
Availability of study drug locally
FG00014 subjects
FG00113 subjects
BG00033.6± 10.5
BG00132.7± 9.9
BG00233.1± 10.2
728
Title
Measurements
Female
BG00059
BG00153
BG002112
Male
BG000305
BG001311
BG002616
728
Title
Measurements
American Indian or Alaska Native
BG00010
BG0016
BG00216
Asian
BG00059
BG00165
BG002124
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG00067
BG00168
BG002135
White
BG000177
BG001170
BG002347
More than one race
BG00051
BG00155
BG002106
Unknown or Not Reported
BG0000
BG0010
BG0020
728
Title
Measurements
BG000434.9± 217.9
BG001415.5± 210.6
BG002425.2± 214.3
705
Title
Measurements
BG00092.08± 32.32
BG00190.47± 30.64
BG00291.27± 31.48
714
Title
Measurements
BG000115.39± 34.67
BG001114.63± 33.55
BG002115.01± 34.09
714
Title
Measurements
BG000157.29± 36.43
BG001156.07± 36.51
BG002156.68± 36.45
714
Title
Measurements
BG000120.85± 83.06
BG001123.23± 82.73
BG002122.04± 82.84
714
Title
Measurements
BG00041.90± 11.67
BG00141.44± 13.08
BG00241.67± 12.38
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Dizziness
Title
Measurements
OG0008.8
OG00137.1
Sleep disorders and disturbances
Title
Measurements
OG00012.1
OG00125.5
Altered sensorium
Title
Measurements
OG0004.4
OG0018.2
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
Dizziness difference
t-test, 2 sided
<0.001
2-sided P-value
Difference in percentages
-28.3
2-Sided
95
-34.0
-22.5
95% CIs were calculated using the Miettinen and Nurminen method.
Superiority
Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
OG000
OG001
Sleep disorders and disturbances difference
t-test, 2 sided
<0.001
2-sided P-value
Difference in percentages
-13.5
2-Sided
95
-19.1
-7.9
95% CIs were calculated using the Miettinen and Nurminen method.
Superiority
Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
OG000
OG001
Altered sensorium difference
t-test, 2 sided
0.033
2-sided P-value
Difference in percentages
-3.8
2-Sided
95
-7.6
-0.3
95% CIs were calculated using the Miettinen and Nurminen method.
Superiority
Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Title
Measurements
OG00077.5(72.8 to 81.7)
OG00173.6(68.8 to 78.1)
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
OG001
Difference in percentages
3.815
2-Sided
95
-2.412
10.042
The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).
Non-Inferiority
Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Title
Measurements
OG00083.8(79.6 to 87.4)
OG00179.7(75.2 to 83.7)
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
Difference in percentages
4.1
2-Sided
95
-1.5
9.7
The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).
Non-Inferiority
Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Title
Measurements
OG00076.1(71.4 to 80.4)
OG00172.8(67.9 to 77.3)
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
Difference in percentages
3.268
2-Sided
95
-3.057
9.593
The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).
Non-Inferiority
Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10
ATRIPLAâ„¢ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
OG000344
OG001329
Title
Denominators
Categories
Title
Measurements
OG000198.4(180.2 to 216.7)
OG001188.4(169.5 to 207.2)
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
Difference in mean %change from baseline
10.1
2-Sided
95
-16.1
36.3
95% CIs were calculated based on t-distribution.
Superiority
Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.
Treatment-naive participants with HIV-1 infection took ATRIPLAâ„¢, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
Units
Counts
Participants
OG000337
OG001311
Title
Denominators
Categories
Title
Measurements
OG000237.7(214.9 to 260.6)
OG001223.0(198.4 to 247.6)
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
Diff in mean % change from baseline
14.7
2-Sided
95
-18.7
48.2
The 95% CI for mean difference in CD4 change was based on t-distribution.
Superiority
Superiority was declared when group difference (MK-1439A-ATRIPLA) was a positive value
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Title
Measurements
OG00082.7
OG00190.7
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
Difference in percentages
-8.0
2-Sided
95
-13.0
-3.1
95% CIs were calculated with the Miettinen & Nurminen method.
Other
Difference in percentage of participants with ≥1 AE(s)
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Title
Measurements
OG0003.0
OG0016.6
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
Difference in percentages
-3.6
2-Sided
95
-6.9
-0.5
95% CIs were calculated with the Miettinen & Nurminen method.
Other
Difference in percentage of participants with ≥1 AE(s)
Units
Counts
Participants
OG000364
OG001364
Title
Denominators
Categories
Depression and suicide/self-injury
Title
Measurements
OG0004.1
OG0016.6
Psychosis and psychotic disorders
Title
Measurements
OG0000.3
OG0011.1
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
OG001
Depression and suicide/self-injury difference
t-test, 2 sided
<0.001
2-sided P-value
Difference in percentages
-2.5
2-Sided
95
-5.9
0.8
95% CIs were calculated using the Miettinen and Nurminen method.
Superiority
Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
OG000
OG001
Psychosis and psychotic disorders difference
t-test, 2 sided
<0.001
2-sided P-value
Difference in percentages
-0.8
2-Sided
95
-2.5
0.5
95% CIs were calculated using the Miettinen and Nurminen method.
Superiority
Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Units
Counts
Participants
OG000330
OG001305
Title
Denominators
Categories
Title
Measurements
OG000-1.58(-3.98 to 0.81)
OG0018.74(5.86 to 11.62)
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
Difference in mean %change from baseline
-10.01
2-Sided
95
-13.53
-6.49
95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
Superiority
Units
Counts
Participants
OG000333
OG001314
Title
Denominators
Categories
Title
Measurements
OG000-3.83(-6.27 to -1.40)
OG00113.26(10.07 to 16.45)
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
Difference in mean %change from baseline
-17.02
2-Sided
95
-20.89
-13.16
95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
Superiority
Units
Counts
Participants
OG000333
OG001314
Title
Denominators
Categories
Title
Measurements
OG000-1.97(-4.74 to 0.79)
OG00121.77(18.35 to 25.18)
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
Difference in mean %change from baseline
-23.44
2-Sided
95
-27.57
-19.32
95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
Superiority
Units
Counts
Participants
OG000333
OG001314
Title
Denominators
Categories
Title
Measurements
OG000-12.40(-19.66 to -5.15)
OG00122.01(11.68 to 32.34)
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
Difference in mean %change from baseline
-35.96
2-Sided
95
-47.10
-24.82
95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
Superiority
Units
Counts
Participants
OG000333
OG001314
Title
Denominators
Categories
Title
Measurements
OG0001.86(0.83 to 2.89)
OG0018.51(7.32 to 9.69)
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
Difference in mean %change from baseline
-6.47
2-Sided
95
-7.97
-4.96
95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.