Switch to Doravirine/Islatravir (DOR/ISL) in Human Immuno... | NCT04223791 | Trialant
NCT04223791
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Mar 27, 2026Actual
Enrollment
643Actual
Phase
Phase 3
Conditions
HIV Infection
Interventions
DOR/ISL
BIC/FTC/TAF
Placebo to BIC/FTC/TAF
Placebo to FDC DOR/ISL
Countries
United States
Australia
Austria
Canada
Finland
France
Germany
Italy
Japan
Puerto Rico
Spain
Protocol Section
Identification Module
NCT ID
NCT04223791
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8591A-018
Secondary IDs
ID
Type
Description
Link
MK-8591A-018
Other Identifier
Merck
205166
Registry Identifier
JAPIC-CTI
2019-000587-23
EudraCT Number
Brief Title
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
Official Title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 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 18, 2020Actual
Primary Completion Date
Aug 26, 2021Actual
Completion Date
Feb 27, 2025Actual
First Submitted Date
Jan 8, 2020
First Submission Date that Met QC Criteria
Jan 8, 2020
First Posted Date
Jan 10, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jul 26, 2022
Results First Submitted that Met QC Criteria
Jul 26, 2022
Results First Posted Date
Aug 22, 2022Actual
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
Mar 9, 2026
Last Update Posted Date
Mar 27, 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 study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Detailed Description
Not provided
Conditions Module
Conditions
HIV 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
643Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
DOR/ISL
Experimental
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive 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
BIC/FTC/TAF
Active Comparator
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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 FDC DOR/ISL
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DOR/ISL
Drug
100 mg DOR/ 0.75 ISL FDC single tablet taken orally once daily
DOR/ISL
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 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. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Week 48
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
Up to 48 weeks
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
Up to 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. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening.
Has been receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
Females are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; 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; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Exclusion Criteria:
Has HIV-2 infection.
Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection.
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.
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies.
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 treatment period.
Has a documented or known virologic resistance to doravirine (DOR).
expects to conceive or donate eggs at any time during the study.
Adult participants living with human immunodeficiency virus-1 (HIV-1) who have been virologically suppressed for ≥3 months and receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with no history of treatment failure were enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive 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
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 25, 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
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
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
BIC/FTC/TAF
Drug
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
BIC/FTC/TAF
Placebo to BIC/FTC/TAF
Drug
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
DOR/ISL
Placebo to FDC DOR/ISL
Drug
Placebo to FDC DOR/ISL in a single tablet taken orally, once daily
BIC/FTC/TAF
Placebo to MK-8591A
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. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Week 144
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Week 48
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48, is presented using the FDA snapshot missing data approach.
Week 48
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Week 96
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96, is presented using the FDA snapshot missing data approach.
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <50 copies/mL at Week 144 is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Week 144
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. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA <40 copies/mL at Week 144, is presented using the FDA snapshot missing data approach.
Week 144
Mean Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 48 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Baseline and Week 48
Mean Change From Baseline in CD4+ T-cell Count at Week 96
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 96 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Baseline and Week 96
Mean Change From Baseline in CD4+ T-cell Count at Week 144
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 144 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Baseline and Week 144
Number of Participants With Viral Drug Resistance-associated Substitutions at Week 48
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Week 48
Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 96 is presented.
Week 96
Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 144 is presented.
Week 144
Change From Baseline in Body Weight at Week 48
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
Baseline and Week 48
Change From Baseline in Body Weight at Week 96
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 96 is presented.
Baseline and Week 96
Change From Baseline in Body Weight at Week 144
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 144 is presented.
Baseline and Week 144
Percentage of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 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.
Up to approximately 55 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 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.
Up to approximately 40 months
Beverly Hills
California
90211
United States
Men's Health Foundation ( Site 2749)
Los Angeles
California
80069
United States
Kaiser Permanente Los Angeles Medical Center ( Site 2775)
Los Angeles
California
90027
United States
Eisenhower Medical Center ( Site 2744)
Palm Springs
California
92264
United States
University of California, Davis, Division of ID Research ( Site 2702)
Sacramento
California
95811
United States
Zuckerberg San Francisco General Hospital UCSF ( Site 2743)
San Francisco
California
94110
United States
Whitman-Walker Clinic ( Site 2728)
Washington D.C.
District of Columbia
20009
United States
TheraFirst Medical Center ( Site 2742)
Fort Lauderdale
Florida
33308
United States
Midway Immunology and Research ( Site 2759)
Ft. Pierce
Florida
34982
United States
The Kinder Medical Group ( Site 2739)
Miami
Florida
33133
United States
AHF South Beach ( Site 2780)
Miami Beach
Florida
33140
United States
Orlando Immunology Center ( Site 2734)
Orlando
Florida
32803
United States
Triple O Research Institute, P.A. ( Site 2755)
West Palm Beach
Florida
33407
United States
Augusta University ( Site 2752)
Augusta
Georgia
30912
United States
Infectious Disease Specialists Of Atlanta PC ( Site 2719)
Decatur
Georgia
30033
United States
Mercer University ( Site 2738)
Macon
Georgia
31201
United States
Chatham County Health Department ( Site 2731)
Savannah
Georgia
31401
United States
Hennepin County Medical Center ( Site 2733)
Minneapolis
Minnesota
55415
United States
Kansas City CARE Clinic ( Site 2718)
Kansas City
Missouri
64111
United States
ID Care ( Site 2751)
Hillsborough
New Jersey
08844
United States
Icahn School of Medicine at Mount Sinai ( Site 2700)
New York
New York
10029
United States
Montefiore Einstein Center ( Site 2730)
The Bronx
New York
10467
United States
North Texas ID Consultants, PA ( Site 2707)
Dallas
Texas
75246
United States
The Crofoot Research Center, Inc. ( Site 2715)
Houston
Texas
77098
United States
DCOL Center for Clinical Research ( Site 2769)
Longview
Texas
75605
United States
Dr. Peter Shalit, MD ( Site 2770)
Seattle
Washington
98104
United States
Multicare Health System ( Site 2713)
Spokane
Washington
99204
United States
St Vincent's Hospital ( Site 3807)
Darlinghurst
New South Wales
2010
Australia
Taylor Square Private Clinic ( Site 3804)
Darlinghurst
New South Wales
2010
Australia
Holdsworth House Medical Practice ( Site 3800)
Sydney
New South Wales
2010
Australia
Holdsworth House Medical Practice - Brisbane ( Site 3810)
Brisbane
Queensland
4006
Australia
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)
Herston
Queensland
4029
Australia
The Alfred Hospital ( Site 3802)
Melbourne
Victoria
3004
Australia
Prahran Market Clinic (PMC) ( Site 3806)
Melbourne
Victoria
3181
Australia
Medical University Vienna ( Site 3402)
Vienna
State of Vienna
1090
Austria
Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)
Vienna
State of Vienna
1100
Austria
Social Medical Center - Otto Wagner Hospital ( Site 3404)
Vienna
State of Vienna
1145
Austria
LKH Graz West ( Site 3401)
Graz
Styria
8020
Austria
Vancouver ID Research and Care Centre Society ( Site 2800)
Vancouver
British Columbia
V6Z 2C7
Canada
Hamilton Health Sciences ( Site 2803)
Hamilton
Ontario
L8L 2X2
Canada
Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)
Montreal
Quebec
H2L 4E9
Canada
Clinique Medicale L Actuel ( Site 2814)
Montreal
Quebec
H2L 4P9
Canada
Helsinki University Hospital ( Site 3200)
Helsinki
Uusimaa
00029
Finland
Hopital Edouard Herriot ( Site 3126)
Lyon
Ain
69003
France
CHU de Nice Hopital Archet 1 ( Site 3103)
Nice
Alpes-Maritimes
06202
France
Hopital Europeen Marseille ( Site 3117)
Marseille
Bouches-du-Rhone
13003
France
Hopital Foch ( Site 3129)
Suresnes
Hauts-de-Seine
92151
France
CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)
Montpellier
Herault
34295
France
CHU Hotel Dieu Nantes ( Site 3120)
Nantes
Loire-Atlantique
44093
France
Centre Hospitalier Regional du Orleans ( Site 3108)
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
FG000322 subjects
FG001321 subjects
Treated
FG000322 subjects
FG001319 subjects
COMPLETED
FG000224 subjectsNumber Completed includes participants who completed base study and participants who entered into study extension.
FG001211 subjectsNumber Completed includes participants who completed base study and participants who entered into study extension.
NOT COMPLETED
FG00098 subjects
FG001110 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0010 subjects
Lost to Follow-up
FG0005 subjects
FG0018 subjects
Physician Decision
FG00018 subjects
FG0017 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
Sponsor Decision
FG00011 subjects
FG00139 subjects
Withdrawal by Subject
FG00056 subjects
FG00140 subjects
Other
FG0006 subjects
FG00115 subjects
Extension Study (Week 144 to Week 168)
Type
Comment
Milestone Data
STARTED
Subset of participants who completed the base study may have been eligible to enter the study extension.
FG000132 subjects
FG001131 subjects
COMPLETED
FG00010 subjects
FG0012 subjects
NOT COMPLETED
FG000122 subjects
FG001129 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0011 subjects
Physician Decision
FG0002 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
BG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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
BG000322
BG001321
BG002643
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
BG00047.6± 12.6
BG00148.0± 11.8
BG00247.8± 12.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000105
BG00178
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00064
BG00155
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0003
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 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. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
HIV-1 RNA ≥50 Copies/mL
Title
Measurements
OG0000.6
OG0010.3
No Virologic Data in Window
Title
Measurements
OG000
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
Unstratified Miettinen and Nurminen
<.001
p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Estimated difference
0.31
2-Sided
95
-1.19
1.96
Treatment difference for DOR/ISL group-BIC/FTC/TAF group.
Non-Inferiority
Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% Confidence Interval (CI) for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points.
Primary
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
Posted
Number
Percentage of Participants
Up to 48 weeks
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Primary
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
Posted
Number
Percentage of Participants
Up to 48 weeks
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
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. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 96
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 144
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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 48
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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 48
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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48, is presented using the FDA snapshot missing data approach.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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 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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 96
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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 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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96, is presented using the FDA snapshot missing data approach.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 96
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA <50 copies/mL at Week 144 is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 144
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA <40 copies/mL at Week 144, is presented using the FDA snapshot missing data approach.
The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
Posted
Number
Percentage of Participants
Week 144
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Secondary
Mean Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 48 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
All participants who received ≥1 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.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline and Week 48
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Secondary
Mean Change From Baseline in CD4+ T-cell Count at Week 96
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 96 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
All participants who received ≥1 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.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline and Week 96
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Secondary
Mean Change From Baseline in CD4+ T-cell Count at Week 144
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 144 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
All participants who received ≥1 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.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline and Week 144
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Secondary
Number of Participants With Viral Drug Resistance-associated Substitutions at Week 48
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Participants with data available at Week 48. Per protocol, participants who met the definition of confirmed virologic rebound (two consecutive [2 to 4 weeks apart] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. 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
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Secondary
Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 96 is presented.
Participants with data available at Week 96. Per protocol, participants who met the definition of confirmed virologic rebound (two consecutive [2 to 4 weeks apart] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. 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
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Secondary
Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 144 is presented.
Participants with data available at Week 144. Per protocol, participants who met the definition of confirmed virologic rebound (two consecutive [2 to 4 weeks apart] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. 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
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Secondary
Change From Baseline in Body Weight at Week 48
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result and had data available for this outcome measure at Week 48.
Posted
Mean
Standard Deviation
kilogram (kg)
Baseline and Week 48
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Secondary
Change From Baseline in Body Weight at Week 96
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 96 is presented.
Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result and had data available for this outcome measure at Week 96.
Posted
Mean
Standard Deviation
kilogram (kg)
Baseline and Week 96
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Secondary
Change From Baseline in Body Weight at Week 144
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 144 is presented.
Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result and had data available for this outcome measure at Week 144.
Posted
Mean
Standard Deviation
kilogram (kg)
Baseline and Week 144
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue 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 One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 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.
All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
Posted
Number
Percentage of Participants
Up to approximately 55 months
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Secondary
Percentage of Participants Who Discontinued Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 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.
All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
Posted
Number
Percentage of Participants
Up to approximately 40 months
ID
Title
Description
OG000
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
OG001
Time Frame
Up to approximately 55 months
Description
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM & AEs reported for base & extension: Weeks 0-48, 48-96, 96-144 &144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation & reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants & are reported by arm 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
DOR/ISL: Base Study Week 0 - Week 48
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
0
322
14
322
85
322
EG001
DOR/ISL: Base Study Week 48-Week 96
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
2
305
19
305
104
305
EG002
DOR/ISL: Base Study Week 96-Week 144
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
0
266
7
266
151
266
EG003
BIC/FTC/TAF: Base Study Week 0 - Week 48
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
321
16
319
93
319
EG004
BIC/FTC/TAF: Base Study Week 48 - Week 96
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
301
11
301
86
301
EG005
BIC/FTC/TAF: Base Study Week 96 - Week 144
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
281
6
281
101
281
EG006
DOR/ISL: Open-Label Extension Week 144-Week 168
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
131
1
131
13
131
EG008
DOR/ISL: Post-Treatment Follow-Up
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
0
196
3
196
14
196
EG009
BIC/FTC/TAF: Post-Treatment Follow-Up
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
0
152
0
152
0
152
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected322 at risk
EG0011 events1 affected305 at risk
EG0021 events1 affected266 at risk
EG0030 events0 affected319 at risk
EG0040 events0 affected301 at risk
EG0050 events0 affected281 at risk
EG0060 events0 affected132 at risk
EG0070 events0 affected131 at risk
EG0080 events0 affected196 at risk
EG0090 events0 affected152 at risk
Aortic valve incompetence
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Arteriospasm coronary
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Goitre
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Splenic artery aneurysm
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Death
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Acute hepatitis B
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cystitis escherichia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Endocarditis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Giardiasis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Vestibular neuronitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Brachial plexopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Thalamic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Drug abuse
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0021 events1 affected266 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Ovarian cyst torsion
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Imprisonment
Social circumstances
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Substance use
Social circumstances
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0010 events0 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected322 at risk
EG0011 events1 affected305 at risk
EG0020 events0 affected266 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected322 at risk
EG0017 events7 affected305 at risk
EG0027 events7 affected266 at risk
EG00321 events20 affected319 at risk
EG0047 events7 affected301 at risk
EG0052 events2 affected281 at risk
EG0062 events2 affected132 at risk
EG0070 events0 affected131 at risk
EG0083 events2 affected196 at risk
EG0090 events0 affected152 at risk
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00019 events19 affected322 at risk
EG00142 events40 affected305 at risk
EG00235 events33 affected266 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00011 events9 affected322 at risk
EG00112 events11 affected305 at risk
EG00217 events16 affected266 at risk
EG003
CD4 lymphocytes decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG00128 events28 affected305 at risk
EG00275 events63 affected266 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected322 at risk
EG00132 events32 affected305 at risk
EG002108 events86 affected266 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00020 events16 affected322 at risk
EG0019 events8 affected305 at risk
EG00210 events9 affected266 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00014 events13 affected322 at risk
EG00111 events9 affected305 at risk
EG0029 events9 affected266 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG00043 events26 affected322 at risk
EG00138 events14 affected305 at risk
EG0027 events3 affected266 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected322 at risk
EG0013 events3 affected305 at risk
EG0025 events5 affected266 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
If publication activity is not directed by the Sponsor, 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
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
Title
Measurements
OG00071.1
OG00174.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in % (DOR/ISL- BIC/FTC/TAF)
-3.5
2-Sided
95
-10.4
3.4
Based on Miettinen and Nurminen method
Other
Difference between treatment groups
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
Title
Measurements
OG0002.5
OG0012.5
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
Difference in % (DOR/ISL- BIC/FTC/TAF)
-0.02
2-Sided
95
-2.7
2.6
Based on Miettinen and Nurminen method
Other
Difference between treatment groups
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
HIV-1 RNA ≥50 Copies/mL
Title
Measurements
OG0000.6
OG0010.3
No Virologic Data in Window
Title
Measurements
OG00014.3
OG0018.8
HIV-1 RNA <50 Copies/mL
Title
Measurements
OG00085.1
OG00190.9
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
Unstratified Miettinen and Nurminen
<0.001
p-value for the treatment differences in percent response was calculated using the unstratified Miettinen and Nurminen method. The p-value corresponds to a 1-sided Type 1 error of 0.02497.
Estimated Difference
0.31
2-Sided
95
-1.19
1.96
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Non-Inferiority
Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL minus BIC/FTC/TAF) is less than 4 percentage points. The p-value for the treatment differences in percent response was calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
HIV-1 RNA ≥50 Copies/mL
Title
Measurements
OG0000.9
OG0011.3
No Virologic Data in Window
Title
Measurements
OG00047.2
OG00133.2
HIV-1 RNA <50 Copies/mL
Title
Measurements
OG00051.9
OG00165.5
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
-0.32
2-Sided
95
-2.36
1.60
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, CIs for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
HIV-1 RNA <50 Copies/mL
Title
Measurements
OG00093.8
OG00194.4
No Virologic Data in Window
Title
Measurements
OG0005.6
OG0015.3
HIV-1 RNA ≥50 Copies/mL
Title
Measurements
OG0000.6
OG0010.3
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
Estimated Difference
-0.57
2-Sided
95
-4.38
3.21
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 CIs for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
Title
Measurements
OG00093.2
OG00194.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Estimated Difference
-0.88
2-Sided
95
-4.81
3.02
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 CIs for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
HIV-1 RNA <50 copies/mL
Title
Measurements
OG00085.1
OG00190.9
No Virologic Data in Window
Title
Measurements
OG00014.3
OG0018.8
HIV-1 RNA ≥50 copies/mL
Title
Measurements
OG0000.6
OG0010.3
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
Estimated Difference
-5.82
2-Sided
95
-10.94
-0.79
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, CIs and p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
Title
Measurements
OG00084.8
OG00190.9
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
-6.13
2-Sided
95
-11.28
-1.08
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, CIs and p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
HIV-1 RNA <50 copies/mL
Title
Measurements
OG00051.9
OG00165.5
No Virologic Data in Window
Title
Measurements
OG00047.2
OG00133.2
HIV-1 RNA ≥50 copies/mL
Title
Measurements
OG0000.9
OG0011.3
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
Estimated Difference
-13.65
2-Sided
95
-21.11
-6.04
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 CIs for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
Title
Measurements
OG00051.9
OG00165.5
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
-13.65
2-Sided
95
-21.11
-6.04
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, CIs and p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000301
OG001298
Title
Denominators
Categories
Title
Measurements
OG000-19.66(-39.78 to 0.45)
OG00140.51(20.66 to 60.36)
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 (DOR/ISL-BIC/FTC/TAF)
-68.09
2-Sided
95
-94.75
-41.43
The mean difference is based on an ANCOVA model.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The Confidence Intervals (CIs) for mean difference in CD4+ T-cell count change from baseline were based on Analysis of Covariance (ANCOVA) model adjusted by baseline CD4+ T-cell count and treatment group.
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000273
OG001290
Title
Denominators
Categories
Title
Measurements
OG0005.36(-19.71 to 30.42)
OG00162.67(40.44 to 84.90)
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 (DOR/ISL-BIC/FTC/TAF)
-65.45
2-Sided
95
-97.02
-33.89
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 ANCOVA model adjusted by baseline CD4+ T-cell count and treatment group.
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000170
OG001213
Title
Denominators
Categories
Title
Measurements
OG0000.48(-28.69 to 29.64)
OG00166.25(38.78 to 93.73)
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 (DOR/ISL-BIC/FTC/TAF)
-78.13
2-Sided
95
-114.63
-41.63
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 ANCOVA model adjusted by baseline CD4+ T-cell count and treatment group.
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG0001
OG0010
Title
Denominators
Categories
Title
Measurements
OG0000
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG0002
OG0010
Title
Denominators
Categories
Title
Measurements
OG0000
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG0002
OG0010
Title
Denominators
Categories
Title
Measurements
OG0000
Units
Counts
Participants
OG000306
OG001302
Title
Denominators
Categories
Title
Measurements
OG0000.23± 4.19
OG0010.55± 4.40
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
Model included terms for baseline weight, sex, race, and treatment.
0.392
Treatment Difference
-0.30
2-Sided
95
-0.99
0.39
Treatment difference for DOR/ISL group-BIC/FTC/TAF group.
Superiority
Units
Counts
Participants
OG000277
OG001293
Title
Denominators
Categories
Title
Measurements
OG0000.29± 5.33
OG0010.72± 5.72
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
Model included terms for baseline weight, sex, race, and treatment.
0.3263
Treatment Difference
-0.45
2-Sided
95
-1.34
0.45
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Superiority
The 95% CIs for treatment difference were calculated from ANCOVA model with terms for baseline weight, sex, race, and treatment. Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Units
Counts
Participants
OG000216
OG001236
Title
Denominators
Categories
Title
Measurements
OG0000.63± 6.67
OG0010.84± 6.41
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
-0.13
2-Sided
95
-1.33
1.06
Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
Other
Type of statistical test 'other' denotes no hypothesis testing was conducted. The 95% CIs for treatment difference were calculated from ANCOVA model with terms for baseline weight, sex, race, and treatment. Treatment difference for DOR/ISL group minus BIC/FTC/TAF group.
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Units
Counts
Participants
OG000322
OG001319
Title
Denominators
Categories
Title
Measurements
OG00096.3
OG00194.4
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.