Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) t... | NCT04233879 | Trialant
NCT04233879
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jun 3, 2026Actual
Enrollment
599Actual
Phase
Phase 3
Conditions
HIV-1 Infection
Interventions
DOR/ISL
BIC/FTC/TAF
Placebo to BIC/FTC/TAF
Placebo to DOR/ISL
Countries
United States
Argentina
Canada
Chile
Colombia
France
Germany
Israel
Italy
Japan
South Africa
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT04233879
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8591A-020
Secondary IDs
ID
Type
Description
Link
MK-8591A-020
Other Identifier
MSD Protocol Number
jRCT2031210024
Registry Identifier
jRCT
2019-000590-23
EudraCT Number
Brief Title
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
Official Title
A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jun 2026
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
Feb 28, 2020Actual
Primary Completion Date
Nov 17, 2022Actual
Completion Date
Jan 29, 2025Actual
First Submitted Date
Jan 15, 2020
First Submission Date that Met QC Criteria
Jan 15, 2020
First Posted Date
Jan 18, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Oct 30, 2023
Results First Submitted that Met QC Criteria
Oct 30, 2023
Results First Posted Date
Nov 21, 2023Actual
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
Jun 1, 2026
Last Update Posted Date
Jun 3, 2026Actual
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
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
Detailed Description
Double-blind treatment with the assigned intervention occurs from Day 1 to Week 96, followed by an open-label portion up to Week 144. Participants who benefit from treatment in the opinion of the Investigator may continue their assigned intervention up to Week 168 (or until they have the option to enroll in a DOR/ISL 100 mg/0.25 mg study, whichever is sooner).
Conditions Module
Conditions
HIV-1 Infection
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
599Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: doravirine/islatravir (DOR/ISL)
Experimental
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Drug: DOR/ISL
Drug: Placebo to BIC/FTC/TAF
Group 2: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Active Comparator
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Drug: BIC/FTC/TAF
Drug: Placebo to DOR/ISL
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DOR/ISL
Drug
100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.
Group 1: doravirine/islatravir (DOR/ISL)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The final analysis for this outcome is presented here.
Week 48
Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one AE up to Week 48 was reported. The final analysis for this outcome is presented here.
Up to approximately 48 weeks
Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE up to Week 48 were reported. The final analysis for this outcome is presented here.
Up to approximately 48 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is human immunodeficiency virus type 1 (HIV-1) positive
Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required
Exclusion Criteria:
Has human immunodeficiency virus type 2 (HIV-2) infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive)
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period
Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention
Has exclusionary laboratory values within 45 days prior to Day 1
Is female and is expecting to conceive or donate eggs at any time during the study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)
A total of 599 participants were randomized in the study and 597 received at least 1 dose of study intervention. The safety analyses were conducted using all participants as treated population, which included all randomized participants who received at least 1 dose of study intervention.
Recruitment Details
Treatment-naïve participants living with Human Immunodeficiency Virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy were enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Periods
Title
Milestones
Reasons Not Completed
Base Study (Day 1 to Week 144)
Type
Comment
Milestone Data
STARTED
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
Mar 26, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
MK-8591A
Doravirine/islatravir
BIC/FTC/TAF
Drug
BIC/FTC/TAF 50/200/25 mg FDC single tablet taken once daily by mouth.
Group 2: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Bictegravir/emtricitabine/tenofovir alafenamide
Placebo to BIC/FTC/TAF
Drug
Placebo single tablet matched to BIC/FTC/TAF taken by mouth.
Group 1: doravirine/islatravir (DOR/ISL)
Placebo to DOR/ISL
Drug
Placebo single tablet matched to DOR/ISL taken by mouth.
Group 2: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Week 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 144 was presented using the Data as Observed (DAO) missing data approach. The final analysis for this outcome is presented here.
Week 144
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <40 copies/mL was determined. The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
Week 48
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <200 copies/mL was determined. The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
Week 48
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
Week 96
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
Week 96
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 144 was presented using the DAO missing data approach. The final analysis for this outcome is presented here.
Week 144
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 144 was presented using the DAO missing data approach. The final analysis for this outcome is presented here.
Week 144
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and at Week 48 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 48 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.
Baseline (Day 1) and Week 48
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 96
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and at Week 96 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 96 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.
Baseline (Day 1) and Week 96
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 144
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and at Week 144 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 144 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.
Baseline (Day 1) and Week 144
Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 48 was presented. The final analysis for this outcome is presented here.
Week 48
Incidence of Viral RASs at Week 96
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 96 was presented. The final analysis for this outcome is presented here.
Week 96
Incidence of Viral RASs at Week 144
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 144 was presented. The final analysis for this outcome is presented here.
Week 144
Mean Change From Baseline in Body Weight at Week 48
Body weight was measured at baseline and at Week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 48 was presented. The final analysis for this outcome is presented here.
Baseline (Day 1) and Week 48
Mean Change From Baseline in Body Weight at Week 96
Body weight was measured at baseline and at Week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 96 was presented. The final analysis for this outcome is presented here.
Baseline (Day 1) and Week 96
Mean Change From Baseline in Body Weight at Week 144
Body weight was measured at baseline and at Week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 144 was presented. The final analysis for this outcome is presented here.
Baseline (Day 1) and Week 144
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one or more AEs is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. The final analysis for this outcome is presented here.
Up to approximately 47 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study intervention due to an AE is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. The final analysis for this outcome is presented here.
Up to approximately 38 months
Pueblo Family Physicians ( Site 5606)
Phoenix
Arizona
85015
United States
Ruane Clinical Research Group, Inc. ( Site 5624)
Los Angeles
California
90036
United States
Midway Immunology and Research ( Site 5622)
Ft. Pierce
Florida
34982
United States
The Kinder Medical Group ( Site 5615)
Miami
Florida
33133
United States
Floridian Clinical Research, LLC ( Site 5625)
Miami Lakes
Florida
33016
United States
Orlando Immunology Center ( Site 5613)
Orlando
Florida
32803
United States
CAN Community Health ( Site 5627)
Sarasota
Florida
34237
United States
Triple O Research Institute, P.A. ( Site 5621)
West Palm Beach
Florida
33407
United States
Columbus Regional Research Institute ( Site 5616)
Columbus
Georgia
31904
United States
Infectious Disease Specialists Of Atlanta PC ( Site 5608)
Decatur
Georgia
30033
United States
Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)
Minneapolis
Minnesota
55415
United States
Kansas City CARE Clinic ( Site 5607)
Kansas City
Missouri
64111
United States
University of Pennsylvania ( Site 5630)
Philadelphia
Pennsylvania
19104
United States
Saint Hope Foundation, Inc. ( Site 5629)
Bellaire
Texas
77401
United States
North Texas ID Consultants, PA ( Site 5604)
Dallas
Texas
75246
United States
Texas Centers for Infectious Disease Associates P.A. ( Site 5619)
Fort Worth
Texas
76104
United States
Helios Salud S.A. ( Site 5802)
Buenos Aires
Buenos Aires F.D.
C1141ACG
Argentina
IDEAA Foundation ( Site 5807)
Buenos Aires
Buenos Aires F.D.
C1405CKC
Argentina
Fundación Huesped ( Site 5801)
C.a.b.a
Buenos Aires F.D.
C1202ABB
Argentina
Instituto CAICI ( Site 5803)
Rosario
Santa Fe Province
S2000PBJ
Argentina
Instituto Oulton ( Site 5804)
Córdoba
X5000JJS
Argentina
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)
Hamilton
Ontario
L8S 14K
Canada
Toronto General Hospital - University Health Network ( Site 5705)
Toronto
Ontario
M5G 2N2
Canada
Clinique Medicale L Actuel ( Site 5714)
Montreal
Quebec
H2L 4P9
Canada
McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)
Montreal
Quebec
H4A 3J1
Canada
Hospital Dr. Hernan Henriquez Aravena ( Site 5905)
Temuco
Araucania
4781151
Chile
Clinica Universidad Catolica del Maule ( Site 5909)
Talca
Maule Region
3460000
Chile
Clinica Arauco Salud ( Site 5900)
Santiago
Region M. de Santiago
7560994
Chile
Hospital Clinico de la Universidad Catolica ( Site 5903)
Santiago
Region M. de Santiago
8331150
Chile
Fundacion Arriaran ( Site 5901)
Santiago
Region M. de Santiago
8360159
Chile
Centro Cardiovascular Cardiosur ( Site 5907)
Santiago
Region M. de Santiago
8910259
Chile
Hospital Universitario San Ignacio ( Site 6005)
Bogotá
Bogota D.C.
110231
Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)
Bogotá
Bogota D.C.
111321
Colombia
Fundacion Valle del Lili ( Site 6001)
Cali
Valle del Cauca Department
760032
Colombia
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)
Paris
Ain
75018
France
Hopital de la Croix-Rousse ( Site 6127)
Lyon
Auvergne-Rhône-Alpes
69004
France
Centre Hospitalier Regional du Orleans ( Site 6108)
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
FG000298 subjects
FG001301 subjects
Treated
FG000298 subjects
FG001299 subjects
COMPLETED
FG00059 subjectsNumber Completed includes participants who completed base study and participants who entered into study extension.
FG00134 subjectsNumber Completed includes participants who completed base study and participants who entered into study extension.
NOT COMPLETED
FG000239 subjects
FG001267 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0010 subjects
Lost to Follow-up
FG00016 subjects
FG00117 subjects
Physician Decision
FG00011 subjects
FG0017 subjects
Sponsor Decision
FG000168 subjects
FG001179 subjects
Withdrawal by Subject
FG00035 subjects
FG00134 subjects
Other
FG0006 subjects
FG00130 subjects
Extension Study (Week 144 to 168)
Type
Comment
Milestone Data
STARTED
Subset of participants who completed the base study may have been eligible to enter the study extension.
FG00021 subjects
FG00127 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
NOT COMPLETED
FG00021 subjects
FG00126 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
Sponsor Decision
FG00020 subjects
FG001
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
BG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000298
BG001301
BG002599
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00034.7± 11.0
BG00135.7± 10.9
BG00235.2± 10.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00077
BG00171
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000123
BG001112
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0012
BG002
Baseline Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Level
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Participants were stratified into the following baseline HIV-1 RNA levels: ≤100,000 copies/mL, >100,000 copies/mL or missing.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
≤100,000 copies/mL
BG000244
BG001
Baseline Cluster of Differentiation 4+ (CD4+) T-Cell Count
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. Participants were stratified into the following baseline CD4+ T-cell counts: <200 cells/mm^3, ≥200 cells/mm^3, or missing.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<200 cells/mm^3
BG00061
BG001
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 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 48
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00088.9
OG00188.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference
0.46
2-Sided
95
-4.73
5.60
Estimated differences, CIs, & p-value for treatment differences in percent response were calculated using Miettinen & Nurminen method stratified by stratum with CMH weights; multiplicity-adjusted 95% CI corresponds to 1-sided Type 1 error of 0.02495
Non-Inferiority
Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points.
Primary
Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one AE up to Week 48 was reported. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Up to approximately 48 weeks
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Primary
Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE up to Week 48 were reported. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Up to approximately 48 weeks
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 96
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 144 was presented using the Data as Observed (DAO) missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available for this outcome measure at Week 144. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 144
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <40 copies/mL was determined. The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 48
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <200 copies/mL was determined. The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 48
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 96
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Secondary
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 96
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Secondary
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 144 was presented using the DAO missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available for this outcome measure at Week 144. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 144
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 144 was presented using the DAO missing data approach. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available for this outcome measure at Week 144. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Week 144
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and at Week 48 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 48 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available, including baseline data available for CD4+ T-cell count at Week 48. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 96
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and at Week 96 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 96 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available, including baseline data available for CD4+ T-cell count at Week 96. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline (Day 1) and Week 96
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 144
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and at Week 144 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 144 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available, including baseline data available for CD4+ T-cell count at Week 144. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline (Day 1) and Week 144
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 48 was presented. The final analysis for this outcome is presented here.
Participants with data available at Week 48. Per protocol, participants who met the definition of confirmed virologic rebound or incomplete virologic response, or who discontinued study intervention for another reason and had HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Among such participants, those with HIV-1 RNA ≥400 copies/mL were included. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
Posted
Count of Participants
Participants
Week 48
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Secondary
Incidence of Viral RASs at Week 96
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 96 was presented. The final analysis for this outcome is presented here.
Participants with data available at Week 96. Per protocol, participants who met the definition of confirmed virologic rebound or incomplete virologic response, or who discontinued study intervention for another reason and had HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Among such participants, those with HIV-1 RNA ≥400 copies/mL were included. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
Posted
Count of Participants
Participants
Week 96
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Secondary
Incidence of Viral RASs at Week 144
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 144 was presented. The final analysis for this outcome is presented here.
Participants with data available at Week 144. Per protocol, participants who met the definition of confirmed virologic rebound or incomplete virologic response, or who discontinued study intervention for another reason and had HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Among such participants, those with HIV-1 RNA ≥400 copies/mL were included. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
Posted
Count of Participants
Participants
Week 144
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Secondary
Mean Change From Baseline in Body Weight at Week 48
Body weight was measured at baseline and at Week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 48 was presented. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available, including baseline data available, for this outcome measure at Week 48. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Mean
95% Confidence Interval
kilogram
Baseline (Day 1) and Week 48
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Mean Change From Baseline in Body Weight at Week 96
Body weight was measured at baseline and at Week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 96 was presented. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of intervention and had data available, including baseline data available, for this outcome measure at Week 96. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Mean
95% Confidence Interval
kilogram
Baseline (Day 1) and Week 96
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Mean Change From Baseline in Body Weight at Week 144
Body weight was measured at baseline and at Week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 144 was presented. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention and had data available, including baseline data available, for this outcome measure at Week 144. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Mean
95% Confidence Interval
kilogram
Baseline (Day 1) and Week 144
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Group 2: BIC/FTC/TAF
Secondary
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one or more AEs is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Up to approximately 47 months
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Secondary
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study intervention due to an AE is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. The final analysis for this outcome is presented here.
All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.
Posted
Number
Percentage of participants
Up to approximately 38 months
ID
Title
Description
OG000
Group 1: DOR/ISL
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Time Frame
Up to approximately 47 months
Description
All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study & open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion & exomphalos) & pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
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
Group 1: DOR/ISL Base Study Week 0 - Week 48
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
2
298
19
298
146
298
EG001
Group 1: DOR/ISL Base Study Week 48-Week 96
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
0
266
14
266
115
266
EG002
Group 1: DOR/ISL Base Study Week 96-Week 144
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
0
146
3
146
42
146
EG003
Group 2: BIC/FTC/TAF Base Study Week 0 - Week 48
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
301
16
299
141
299
EG004
Group 2: BIC/FTC/TAF Base Study Week 48 - Week 96
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
267
13
267
124
267
EG005
Group 2: BIC/FTC/TAF Base Study Week 96 - Week 144
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
143
1
143
37
143
EG006
Group 1: DOR/ISL Open-Label Extension Week 144-Week 168
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
0
21
0
21
3
21
EG007
Group 2: BIC/FTC/TAF Open-Label Extension Week 144 - Week 168
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
27
0
27
2
27
EG008
Group 1: DOR/ISL Post-Treatment Follow-Up
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine [DOR]/0.75 mg islatravir [ISL]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
1
112
3
112
8
112
EG009
Group 2: BIC/FTC/TAF Post-Treatment Follow-Up
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
128
1
128
2
128
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG0031 events1 affected299 at risk
EG0041 events1 affected267 at risk
EG0050 events0 affected143 at risk
EG0060 events0 affected21 at risk
EG0070 events0 affected27 at risk
EG0080 events0 affected112 at risk
EG0090 events0 affected128 at risk
Angina unstable
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Heart failure with preserved ejection fraction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Exomphalos
Congenital, familial and genetic disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Acute hepatitis B
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0021 events1 affected146 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Lymphogranuloma venereum
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0021 events1 affected146 at risk
EG003
Scrotal cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0021 events1 affected146 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0021 events1 affected146 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0021 events1 affected146 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Poisoning
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Stab wound
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Suture rupture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
CD4 lymphocytes decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Liver function test increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Migraine
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Abortion incomplete
Pregnancy, puerperium and perinatal conditions
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Suicidal behaviour
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00028 events26 affected298 at risk
EG0017 events6 affected266 at risk
EG0022 events2 affected146 at risk
EG00321 events20 affected299 at risk
EG0045 events5 affected267 at risk
EG0052 events2 affected143 at risk
EG0060 events0 affected21 at risk
EG0070 events0 affected27 at risk
EG0080 events0 affected112 at risk
EG0091 events1 affected128 at risk
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00045 events42 affected298 at risk
EG00121 events20 affected266 at risk
EG0022 events2 affected146 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00016 events15 affected298 at risk
EG00114 events14 affected266 at risk
EG0024 events4 affected146 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG00021 events17 affected298 at risk
EG00112 events7 affected266 at risk
EG0023 events3 affected146 at risk
EG003
CD4 lymphocytes decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected298 at risk
EG00135 events28 affected266 at risk
EG00213 events12 affected146 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG00028 events27 affected298 at risk
EG00175 events64 affected266 at risk
EG00229 events25 affected146 at risk
EG003
Weight increased
Investigations
MedDRA 27.1
Systematic Assessment
EG00019 events19 affected298 at risk
EG0012 events2 affected266 at risk
EG0020 events0 affected146 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00017 events16 affected298 at risk
EG00112 events11 affected266 at risk
EG0023 events2 affected146 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG00036 events31 affected298 at risk
EG00114 events13 affected266 at risk
EG0022 events2 affected146 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG00014 events13 affected298 at risk
EG0014 events4 affected266 at risk
EG0021 events1 affected146 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 will comply with the requirements for publication of study results. The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
bictegravir, emtricitabine, tenofovir alafenamide, drug combination
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
25 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
148
Male
BG000221
BG001230
BG002451
235
Not Hispanic or Latino
BG000171
BG001184
BG002355
Unknown or Not Reported
BG0004
BG0015
BG0029
4
Asian
BG00016
BG00120
BG00236
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG00086
BG00190
BG002176
White
BG000171
BG001169
BG002340
More than one race
BG00023
BG00119
BG00242
Unknown or Not Reported
BG0000
BG0011
BG0021
239
BG002483
>100,000 copies/mL
BG00054
BG00160
BG002114
Missing
BG0000
BG0012
BG0022
60
BG002121
≥200 cells/mm^3
BG000237
BG001239
BG002476
Missing
BG0000
BG0012
BG0022
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00090.6
OG00186.3
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
Percentage Difference
4.3
2-Sided
95
-0.8
9.6
Miettinen & Nurminen method was used to generate percentage difference and the associated 95%CI.
Other
Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG0007.4
OG0013.3
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
Percentage Difference
4.0
2-Sided
95
0.4
7.9
Miettinen & Nurminen method was used to generate percentage difference and the associated 95%CI.
Other
Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00051.7
OG00157.9
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
Miettinen and Nurminen method
0.945
The estimated differences, CIs and p-value for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Estimated Difference
-6.42
2-Sided
95
-14.21
1.46
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Non-Inferiority
Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points. The multiplicity-adjusted 95% CI is shown corresponding to a 1-sided Type 1 error of 0.02495. The estimated differences, CIs and p-value for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG00039
OG00141
Title
Denominators
Categories
Title
Measurements
OG00064.1
OG00182.9
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
Estimated Difference
-19.5
2-Sided
95
-38.0
0.2
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The CIs for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00088.6
OG00186.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference
2.12
2-Sided
95
-3.23
7.48
The estimated differences, CIs and p-value for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Non-Inferiority
Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00089.6
OG00188.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference
0.83
2-Sided
95
-4.25
5.90
The estimated differences, CIs and p-value for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Non-Inferiority
Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00051.0
OG00157.5
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
Estimated Difference
-6.74
2-Sided
95
-14.53
1.15
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The estimated differences, and confidence intervals (CIs) for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00052.3
OG00158.5
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
Estimated Difference
-6.41
2-Sided
95
-14.20
1.46
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The estimated differences, and confidence intervals (CIs) for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG00039
OG00141
Title
Denominators
Categories
Title
Measurements
OG00064.1
OG00182.9
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
Estimated Difference
-19.5
2-Sided
95
-38.0
0.2
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The CIs for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG00039
OG00141
Title
Denominators
Categories
Title
Measurements
OG00064.1
OG00182.9
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
Estimated Difference
-19.5
2-Sided
95
-38.0
0.2
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The CIs for the treatment differences in percent response were calculated using the Miettinen and Nurminen method stratified by stratum with Cochran-Mantel-Haenszel (CMH) weights.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000263
OG001263
Title
Denominators
Categories
Title
Measurements
OG000182.4(162.0 to 202.7)
OG001233.5(211.8 to 255.3)
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000159
OG001168
Title
Denominators
Categories
Title
Measurements
OG000217.05(187.52 to 246.58)
OG001319.92(290.53 to 349.32)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
-91.75
2-Sided
95
-132.59
-50.90
Treatment Difference (DOR/ISL minus BIC/FTC/TAF)
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The CIs for mean difference in CD4+ T-cell count change from baseline were based on analysis of covariance (ANCOVA) models adjusted by baseline CD4+ T-cell count, stratum, and treatment group.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG00024
OG00132
Title
Denominators
Categories
Title
Measurements
OG000239.6(177.4 to 301.8)
OG001350.9(265.7 to 436.1)
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
Mean Difference (Final Values)
-111.8
2-Sided
95
-218.8
-4.8
Treatment Difference (DOR/ISL minus BIC/FTC/TAF)
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The CIs for mean difference in CD4+ T-cell count change from baseline were based on analysis of covariance (ANCOVA) models adjusted by baseline CD4+ T-cell count, stratum, and treatment group.
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG0005
OG0019
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG0005
OG0019
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000270
OG001268
Title
Denominators
Categories
Title
Measurements
OG0003.45(2.83 to 4.06)
OG0013.32(2.68 to 3.96)
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
A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.
0.73
Treatment Difference
0.15
2-Sided
95
-0.71
1.02
ANCOVA model was used to generate treatment difference and the associated 95%CI. The 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline weight, sex, race, stratum, and treatment.
Superiority
Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000189
OG001201
Title
Denominators
Categories
Title
Measurements
OG0003.31(2.45 to 4.18)
OG0014.13(3.15 to 5.11)
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
A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.
0.268
Estimated Difference
-0.74
2-Sided
97
-2.19
0.71
The CIs for treatment difference were calculated from ANCOVA models with terms for baseline weight, sex, race, stratum and treatment. The CIs at week 96 is 97% corresponds to a 1-sided Type 1 error of 0.015.
Superiority
Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0. The CIs for treatment difference were calculated from ANCOVA models with terms for baseline weight, sex, race, stratum and treatment.
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG00040
OG00142
Title
Denominators
Categories
Title
Measurements
OG0004.55(2.40 to 6.70)
OG0013.55(-1.46 to 8.56)
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
Estimated Difference
1.08
2-Sided
95
-4.07
6.24
The CIs for treatment difference were calculated from ANCOVA models with terms for baseline weight, sex, race, stratum and treatment.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The CIs for treatment difference were calculated from ANCOVA models with terms for baseline weight, sex, race, stratum and treatment.
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000298
OG001299
Title
Denominators
Categories
Title
Measurements
OG00096.6
OG00194.0
OG001
Group 2: BIC/FTC/TAF
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir [BIC], 200 mg emtricitabine [FTC], 25 mg tenofovir alafenamide [TAF]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.