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)

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)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Placebo to BIC/FTC/TAF; Drug: BIC/FTC/TAF; Drug: DOR/ISL; Drug: Placebo to FDC DOR/ISL

• Study Type: Interventional
• Enrollment (Actual): 643
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital ( Site 3807)
    • Darlinghurst, New South Wales, Australia, 2010
      • Taylor Square Private Clinic ( Site 3804)
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice ( Site 3800)
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Holdsworth House Medical Practice - Brisbane ( Site 3810)
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital ( Site 3802)
    • Melbourne, Victoria, Australia, 3181
      • Prahran Market Clinic (PMC) ( Site 3806)
• Austria
  • Styria
    • Graz, Styria, Austria, 8020
      • LKH Graz West ( Site 3401)
  • Vienna
    • Vienna, Vienna, Austria, 1090
      • Medical University Vienna ( Site 3402)
    • Vienna, Vienna, Austria, 1100
      • Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)
    • Vienna, Vienna, Austria, 1145
      • Social Medical Center - Otto Wagner Hospital ( Site 3404)
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver ID Research and Care Centre Society ( Site 2800)
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences ( Site 2803)
  • Quebec
    • Montreal, Quebec, Canada, H2L 4E9
      • Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)
    • Montreal, Quebec, Canada, H2L 4P9
      • Clinique Medicale L Actuel ( Site 2814)
• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Hospital ( Site 3200)
• France
  • Paris, France, 75012
    • Hopital Saint-Antoine ( Site 3113)
  • Paris, France, 75013
    • Hopital Pitie Salpetriere ( Site 3111)
  • Paris, France, 75020
    • Hopital Tenon ( Site 3118)
  • Ain
    • Lyon, Ain, France, 69003
      • Hopital Edouard Herriot ( Site 3126)
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • CHU de Nice Hopital Archet 1 ( Site 3103)
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13003
      • Hopital Europeen Marseille ( Site 3117)
  • Hauts-de-Seine
    • Suresnes, Hauts-de-Seine, France, 92151
      • Hopital Foch ( Site 3129)
  • Herault
    • Montpellier, Herault, France, 34295
      • CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • CHU Hotel Dieu Nantes ( Site 3120)
  • Loiret
    • Orléans, Loiret, France, 45000
      • Centre Hospitalier Regional du Orleans ( Site 3108)
  • Meurthe-et-Moselle
    • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
      • CHU de Nancy Hopital Brabois Adultes ( Site 3128)
  • Nord
    • Tourcoing, Nord, France, 59208
      • Centre Hospitalier de Tourcoing ( Site 3100)
• Germany
  • Berlin, Germany, 10439
    • ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)
  • Berlin, Germany, 12167
    • EPIMED GmbH ( Site 3008)
  • Hamburg, Germany, 20146
    • ICH Study Center GmbH & Co.KG ( Site 3009)
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)
  • Bavaria
    • Munich, Bavaria, Germany, 80335
      • MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)
    • Munich, Bavaria, Germany, 80336
      • Klinikum der LMU München ( Site 3004)
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar der Technischen Universitat ( Site 3005)
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60596
      • Infektiologikum ( Site 3001)
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover ( Site 3012)
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Universitaetsklinikum Bonn ( Site 3000)
    • Essen, North Rhine-Westphalia, Germany, 45122
      • Universitaetsklinikum Essen ( Site 3007)
• Italy
  • Milan, Italy, 20127
    • Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)
  • Milan, Italy, 20142
    • Azienda Ospedaliera San Paolo ( Site 3503)
  • Milan, Italy, 20157
    • ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)
  • Naples, Italy, 80131
    • A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)
• Japan
  • Osaka, Japan, 540-0006
    • National Hospital Organization Osaka National Hospital ( Site 7202)
  • Tokyo, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine ( Site 7201)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center ( Site 7203)
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • CAIMED Center - Ponce School of Medicine ( Site 2903)
  • Rio Piedras, Puerto Rico, 00925
    • Puerto Rico CONCRA ( Site 2904)
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico Inc ( Site 2900)
  • San Juan, Puerto Rico, 00909
    • Hope Clinical Research, Inc. ( Site 2902)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial ( Site 3600)
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon ( Site 3603)
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor ( Site 3606)
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal ( Site 3611)
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre de Madrid ( Site 3605)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 3604)
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria ( Site 3609)
  • Barcelona [Barcelona]
    • Badalona, Barcelona [Barcelona], Spain, 08916
      • Hospital Universitari Germans Trias i Pujol ( Site 3601)
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Hospital Universitari Vall d Hebron ( Site 3602)
    • LHospitalet de Llobregat, Barcelona [Barcelona], Spain, 08907
      • Hospital Universitari de Bellvitge ( Site 3612)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Pueblo Family Physicians ( Site 2717)
  • California
    • Beverly Hills, California, United States, 90211
      • Pacific Oaks Medical Group ( Site 2765)
    • Los Angeles, California, United States, 80069
      • Men's Health Foundation ( Site 2749)
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center ( Site 2775)
    • Palm Springs, California, United States, 92264
      • Eisenhower Medical Center ( Site 2744)
    • Sacramento, California, United States, 95811
      • University of California, Davis, Division of ID Research ( Site 2702)
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital UCSF ( Site 2743)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20009
      • Whitman-Walker Clinic ( Site 2728)
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • TheraFirst Medical Center ( Site 2742)
    • Ft. Pierce, Florida, United States, 34982
      • Midway Immunology and Research ( Site 2759)
    • Miami, Florida, United States, 33133
      • The Kinder Medical Group ( Site 2739)
    • Miami Beach, Florida, United States, 33140
      • AHF South Beach ( Site 2780)
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center ( Site 2734)
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute, P.A. ( Site 2755)
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University ( Site 2752)
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialists Of Atlanta PC ( Site 2719)
    • Macon, Georgia, United States, 31201
      • Mercer University ( Site 2738)
    • Savannah, Georgia, United States, 31401
      • Chatham County Health Department ( Site 2731)
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center ( Site 2733)
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Kansas City CARE Clinic ( Site 2718)
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care ( Site 2751)
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai ( Site 2700)
    • The Bronx, New York, United States, 10467
      • Montefiore Einstein Center ( Site 2730)
  • Texas
    • Dallas, Texas, United States, 75246
      • North Texas ID Consultants, PA ( Site 2707)
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, Inc. ( Site 2715)
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research ( Site 2769)
  • Washington
    • Seattle, Washington, United States, 98104
      • Dr. Peter Shalit, MD ( Site 2770)
    • Spokane, Washington, United States, 99204
      • Multicare Health System ( Site 2713)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Placebo to BIC/FTC/TAF; Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily; Drug: DOR/ISL; 100 mg DOR/ 0.75 ISL FDC single tablet taken orally once daily; Other Names: MK-8591A
Active Comparator: 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.	Drug: BIC/FTC/TAF; 50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily; Drug: Placebo to FDC DOR/ISL; Placebo to FDC DOR/ISL in a single tablet taken orally, once daily; Other Names: Placebo to MK-8591A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Mills AM, Rizzardini G, Ramgopal MN, Osiyemi OO, Bogner JR, Hagins DP, Paredes R, Reynes J, Rockstroh JK, Carr A, Su FH, Klopfer SO, Eves K, Plank RM, Correll T, Fox MC. Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial. Lancet HIV. 2024 Jun;11(6):e357-e368. doi: 10.1016/S2352-3018(24)00030-4. Epub 2024 May 8.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): August 26, 2021
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-Retroviral Agents; Islatravir
• Other Study ID Numbers: 8591A-018; MK-8591A-018 (Other Identifier: Merck); 205166 (Registry Identifier: JAPIC-CTI); 2019-000587-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No