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)
NCT ID: NCT04223791
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
643 participants
INTERVENTIONAL
2020-02-18
2025-02-27
Brief Summary
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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
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Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
NCT04233879
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
NCT04223778
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
NCT05705349
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DOR/ISL
A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks.
DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
Placebo to BIC/FTC/TAF
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
BIC/FTC/TAF
50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156.
DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
BIC/FTC/TAF
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Placebo to FDC DOR/ISL
Placebo to FDC DOR/ISL in a tablet taken orally, once daily
Interventions
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DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
BIC/FTC/TAF
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Placebo to BIC/FTC/TAF
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
Placebo to FDC DOR/ISL
Placebo to FDC DOR/ISL in a tablet taken orally, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has been receiving 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.
* Female is eligible to participate if she is 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 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 DOR.
* Female expects to conceive or donate eggs at any time during the study.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Pueblo Family Physicians ( Site 2717)
Phoenix, Arizona, United States
Pacific Oaks Medical Group ( Site 2765)
Beverly Hills, California, United States
Men's Health Foundation ( Site 2749)
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center ( Site 2775)
Los Angeles, California, United States
Eisenhower Medical Center ( Site 2744)
Palm Springs, California, United States
University of California, Davis, Division of ID Research ( Site 2702)
Sacramento, California, United States
Zuckerberg San Francisco General Hospital UCSF ( Site 2743)
San Francisco, California, United States
Whitman-Walker Clinic ( Site 2728)
Washington D.C., District of Columbia, United States
TheraFirst Medical Center ( Site 2742)
Fort Lauderdale, Florida, United States
Midway Immunology and Research ( Site 2759)
Ft. Pierce, Florida, United States
The Kinder Medical Group ( Site 2739)
Miami, Florida, United States
AHF South Beach ( Site 2780)
Miami Beach, Florida, United States
Orlando Immunology Center ( Site 2734)
Orlando, Florida, United States
Triple O Research Institute, P.A. ( Site 2755)
West Palm Beach, Florida, United States
Augusta University ( Site 2752)
Augusta, Georgia, United States
Infectious Disease Specialists Of Atlanta PC ( Site 2719)
Decatur, Georgia, United States
Mercer University ( Site 2738)
Macon, Georgia, United States
Chatham County Health Department ( Site 2731)
Savannah, Georgia, United States
Hennepin County Medical Center ( Site 2733)
Minneapolis, Minnesota, United States
Kansas City CARE Clinic ( Site 2718)
Kansas City, Missouri, United States
ID Care ( Site 2751)
Hillsborough, New Jersey, United States
Icahn School of Medicine at Mount Sinai ( Site 2700)
New York, New York, United States
Montefiore Einstein Center ( Site 2730)
The Bronx, New York, United States
North Texas ID Consultants, PA ( Site 2707)
Dallas, Texas, United States
The Crofoot Research Center, Inc. ( Site 2715)
Houston, Texas, United States
DCOL Center for Clinical Research ( Site 2769)
Longview, Texas, United States
Dr. Peter Shalit, MD ( Site 2770)
Seattle, Washington, United States
Multicare Health System ( Site 2713)
Spokane, Washington, United States
St Vincent's Hospital ( Site 3807)
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic ( Site 3804)
Darlinghurst, New South Wales, Australia
Holdsworth House Medical Practice ( Site 3800)
Sydney, New South Wales, Australia
Holdsworth House Medical Practice - Brisbane ( Site 3810)
Brisbane, Queensland, Australia
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)
Herston, Queensland, Australia
The Alfred Hospital ( Site 3802)
Melbourne, Victoria, Australia
Prahran Market Clinic (PMC) ( Site 3806)
Melbourne, Victoria, Australia
LKH Graz West ( Site 3401)
Graz, Styria, Austria
Medical University Vienna ( Site 3402)
Vienna, Vienna, Austria
Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)
Vienna, Vienna, Austria
Social Medical Center - Otto Wagner Hospital ( Site 3404)
Vienna, Vienna, Austria
Vancouver ID Research and Care Centre Society ( Site 2800)
Vancouver, British Columbia, Canada
Hamilton Health Sciences ( Site 2803)
Hamilton, Ontario, Canada
Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)
Montreal, Quebec, Canada
Clinique Medicale L Actuel ( Site 2814)
Montreal, Quebec, Canada
Helsinki University Hospital ( Site 3200)
Helsinki, Uusimaa, Finland
Hopital Edouard Herriot ( Site 3126)
Lyon, Ain, France
CHU de Nice Hopital Archet 1 ( Site 3103)
Nice, Alpes-Maritimes, France
Hopital Europeen Marseille ( Site 3117)
Marseille, Bouches-du-Rhone, France
Hopital Foch ( Site 3129)
Suresnes, Hauts-de-Seine, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)
Montpellier, Herault, France
CHU Hotel Dieu Nantes ( Site 3120)
Nantes, Loire-Atlantique, France
Centre Hospitalier Regional du Orleans ( Site 3108)
Orléans, Loiret, France
CHU de Nancy Hopital Brabois Adultes ( Site 3128)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier de Tourcoing ( Site 3100)
Tourcoing, Nord, France
Hopital Saint-Antoine ( Site 3113)
Paris, , France
Hopital Pitie Salpetriere ( Site 3111)
Paris, , France
Hopital Tenon ( Site 3118)
Paris, , France
MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)
Munich, Bavaria, Germany
Klinikum der LMU München ( Site 3004)
Munich, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universitat ( Site 3005)
Munich, Bavaria, Germany
Infektiologikum ( Site 3001)
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover ( Site 3012)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Bonn ( Site 3000)
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen ( Site 3007)
Essen, North Rhine-Westphalia, Germany
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)
Berlin, , Germany
EPIMED GmbH ( Site 3008)
Berlin, , Germany
ICH Study Center GmbH & Co.KG ( Site 3009)
Hamburg, , Germany
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)
Hamburg, , Germany
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)
Milan, Lombardy, Italy
Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)
Milan, , Italy
Azienda Ospedaliera San Paolo ( Site 3503)
Milan, , Italy
ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)
Milan, , Italy
A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)
Napoli, , Italy
National Hospital Organization Nagoya Medical Center ( Site 7203)
Nagoya, Aichi-ken, Japan
National Hospital Organization Osaka National Hospital ( Site 7202)
Osaka, , Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 7201)
Tokyo, , Japan
CAIMED Center - Ponce School of Medicine ( Site 2903)
Ponce, , Puerto Rico
Puerto Rico CONCRA ( Site 2904)
Rio Piedras, , Puerto Rico
Clinical Research Puerto Rico Inc ( Site 2900)
San Juan, , Puerto Rico
Hope Clinical Research, Inc. ( Site 2902)
San Juan, , Puerto Rico
Hospital Universitari Germans Trias i Pujol ( Site 3601)
Badalona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d Hebron ( Site 3602)
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitari de Bellvitge ( Site 3612)
LHospitalet de Llobregat, Barcelona [Barcelona], Spain
Hospital Clinic i Provincial ( Site 3600)
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 3603)
Madrid, , Spain
Hospital Universitario Infanta Leonor ( Site 3606)
Madrid, , Spain
Hospital Universitario Ramon y Cajal ( Site 3611)
Madrid, , Spain
Hospital 12 de Octubre de Madrid ( Site 3605)
Madrid, , Spain
Hospital Universitario La Paz ( Site 3604)
Madrid, , Spain
Hospital Universitario Virgen de la Victoria ( Site 3609)
Málaga, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8591A-018
Identifier Type: OTHER
Identifier Source: secondary_id
205166
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-000587-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591A-018
Identifier Type: -
Identifier Source: org_study_id
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