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)

Last updated: March 11, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Hiv/aids

Aids And Aids Related Infections

Treatment

DOR/ISL

Placebo to FDC DOR/ISL

BIC/FTC/TAF

Clinical Study ID

NCT04223791
8591A-018
MK-8591A-018
205166
2019-000587-23
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50copies/mL at screening.

  • 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 ofprior virologic treatment failure on any past or current regimen.

  • Female is eligible to participate if she is not pregnant or breastfeeding, and atleast one of the following conditions applies: Is not a woman of childbearingpotential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or beabstinent from heterosexual intercourse as their preferred and usual lifestyle; aWOCBP must have a negative highly sensitive pregnancy test ([urine or serum] asrequired by local regulations) within 24 hours before the first dose of studyintervention; if a urine test cannot be confirmed as negative (e.g. an ambiguousresult), a serum pregnancy test is required. In such cases, the participant must beexcluded from participation if the serum pregnancy result is positive.

Exclusion

Exclusion Criteria:

  • Has HIV-2 infection.

  • Has an active diagnosis of hepatitis due to any cause, including active Hepatitis BVirus (HBV) co-infection.

  • Has a history of malignancy ≤5 years prior to signing informed consent except foradequately 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, immunemodulators, or any prohibited therapies.

  • Is currently participating in or has participated in a clinical study with aninvestigational compound or device from 45 days prior to Day 1 through the studytreatment period.

  • Has a documented or known virologic resistance to DOR.

  • Female expects to conceive or donate eggs at any time during the study.

Study Design

Total Participants: 643
Treatment Group(s): 4
Primary Treatment: DOR/ISL
Phase: 3
Study Start date:
February 18, 2020
Estimated Completion Date:
February 27, 2025

Connect with a study center

  • St Vincent's Hospital ( Site 3807)

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Taylor Square Private Clinic ( Site 3804)

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Holdsworth House Medical Practice ( Site 3800)

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Holdsworth House Medical Practice - Brisbane ( Site 3810)

    Brisbane, Queensland 4006
    Australia

    Site Not Available

  • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Prahran Market Clinic (PMC) ( Site 3806)

    Melbourne, Victoria 3181
    Australia

    Site Not Available

  • The Alfred Hospital ( Site 3802)

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • LKH Graz West ( Site 3401)

    Graz, Steiermark 8020
    Austria

    Site Not Available

  • Medical University Vienna ( Site 3402)

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Social Medical Center - Otto Wagner Hospital ( Site 3404)

    Vienna, Wien 1145
    Austria

    Site Not Available

  • Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)

    Vienna, Wien 1100
    Austria

    Site Not Available

  • Vancouver ID Research and Care Centre Society ( Site 2800)

    Vancouver, British Columbia V6Z 2C7
    Canada

    Site Not Available

  • Hamilton Health Sciences ( Site 2803)

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Clinique Medicale L Actuel ( Site 2814)

    Montreal, Quebec H2L 4P9
    Canada

    Site Not Available

  • Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)

    Montreal, Quebec H2L 4E9
    Canada

    Site Not Available

  • Helsinki University Hospital ( Site 3200)

    Helsinki, Uusimaa 00029
    Finland

    Site Not Available

  • Hopital Edouard Herriot ( Site 3126)

    Lyon, Ain 69003
    France

    Site Not Available

  • CHU de Nice Hopital Archet 1 ( Site 3103)

    Nice, Alpes-Maritimes 06202
    France

    Site Not Available

  • Hopital Europeen Marseille ( Site 3117)

    Marseille, Bouches-du-Rhone 13003
    France

    Site Not Available

  • Hopital Foch ( Site 3129)

    Suresnes, Hauts-de-Seine 92151
    France

    Site Not Available

  • CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)

    Montpellier, Herault 34295
    France

    Site Not Available

  • CHU Hotel Dieu Nantes ( Site 3120)

    Nantes, Loire-Atlantique 44093
    France

    Site Not Available

  • Centre Hospitalier Regional du Orleans ( Site 3108)

    Orleans, Loiret 45000
    France

    Site Not Available

  • CHU de Nancy Hopital Brabois Adultes ( Site 3128)

    Vandoeuvre les Nancy, Meurthe-et-Moselle 54511
    France

    Site Not Available

  • Centre Hospitalier de Tourcoing ( Site 3100)

    Tourcoing, Nord 59208
    France

    Site Not Available

  • Hopital Pitie Salpetriere ( Site 3111)

    Paris, 75013
    France

    Site Not Available

  • Hopital Saint-Antoine ( Site 3113)

    Paris, 75012
    France

    Site Not Available

  • Hopital Tenon ( Site 3118)

    Paris, 75020
    France

    Site Not Available

  • Klinikum der LMU München ( Site 3004)

    Muenchen, Bayern 80336
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universitat ( Site 3005)

    Muenchen, Bayern 81675
    Germany

    Site Not Available

  • MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)

    Muenchen, Bayern 80335
    Germany

    Site Not Available

  • Infektiologikum ( Site 3001)

    Frankfurt am Main, Hessen 60596
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover ( Site 3012)

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn ( Site 3000)

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Universitaetsklinikum Essen ( Site 3007)

    Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • EPIMED GmbH ( Site 3008)

    Berlin, 12167
    Germany

    Site Not Available

  • ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)

    Berlin, 10439
    Germany

    Site Not Available

  • ICH Study Center GmbH & Co.KG ( Site 3009)

    Hamburg, 20146
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)

    Hamburg, 20246
    Germany

    Site Not Available

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)

    Milano, 20157
    Italy

    Site Not Available

  • Azienda Ospedaliera San Paolo ( Site 3503)

    Milano, 20142
    Italy

    Site Not Available

  • Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)

    Milano, 20127
    Italy

    Site Not Available

  • A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)

    Napoli, 80131
    Italy

    Site Not Available

  • National Hospital Organization Nagoya Medical Center ( Site 7203)

    Nagoya, Aichi 460-0001
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital ( Site 7202)

    Osaka, 540-0006
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine ( Site 7201)

    Tokyo, 162-8655
    Japan

    Site Not Available

  • CAIMED Center - Ponce School of Medicine ( Site 2903)

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Puerto Rico CONCRA ( Site 2904)

    Rio Piedras, 00925
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico Inc ( Site 2900)

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Hope Clinical Research, Inc. ( Site 2902)

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol ( Site 3601)

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Hospital Universitari Vall d Hebron ( Site 3602)

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge ( Site 3612)

    LHospitalet de Llobregat, Barcelona [Barcelona] 08907
    Spain

    Site Not Available

  • Hospital Clinic i Provincial ( Site 3600)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital 12 de Octubre de Madrid ( Site 3605)

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon ( Site 3603)

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor ( Site 3606)

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 3604)

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal ( Site 3611)

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria ( Site 3609)

    Malaga, 29010
    Spain

    Site Not Available

  • Pueblo Family Physicians ( Site 2717)

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Pacific Oaks Medical Group ( Site 2765)

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center ( Site 2775)

    Los Angeles, California 90027
    United States

    Site Not Available

  • Men's Health Foundation ( Site 2749)

    Los Angeles, California 80069
    United States

    Site Not Available

  • Eisenhower Medical Center ( Site 2744)

    Palm Springs, California 92264
    United States

    Site Not Available

  • University of California, Davis, Division of ID Research ( Site 2702)

    Sacramento, California 95811
    United States

    Site Not Available

  • Zuckerberg San Francisco General Hospital UCSF ( Site 2743)

    San Francisco, California 94110
    United States

    Site Not Available

  • Whitman-Walker Clinic ( Site 2728)

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • TheraFirst Medical Center ( Site 2742)

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Midway Immunology and Research ( Site 2759)

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • The Kinder Medical Group ( Site 2739)

    Miami, Florida 33133
    United States

    Site Not Available

  • AHF South Beach ( Site 2780)

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 2734)

    Orlando, Florida 32803
    United States

    Site Not Available

  • Triple O Research Institute, P.A. ( Site 2755)

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Augusta University ( Site 2752)

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Infectious Disease Specialists Of Atlanta PC ( Site 2719)

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Mercer University ( Site 2738)

    Macon, Georgia 31201
    United States

    Site Not Available

  • Chatham County Health Department ( Site 2731)

    Savannah, Georgia 31401
    United States

    Site Not Available

  • Hennepin County Medical Center ( Site 2733)

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Kansas City CARE Clinic ( Site 2718)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • ID Care ( Site 2751)

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • Montefiore Einstein Center ( Site 2730)

    Bronx, New York 10467
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai ( Site 2700)

    New York, New York 10029
    United States

    Site Not Available

  • North Texas ID Consultants, PA ( Site 2707)

    Dallas, Texas 75246
    United States

    Site Not Available

  • The Crofoot Research Center, Inc. ( Site 2715)

    Houston, Texas 77098
    United States

    Site Not Available

  • DCOL Center for Clinical Research ( Site 2769)

    Longview, Texas 75605
    United States

    Site Not Available

  • Dr. Peter Shalit, MD ( Site 2770)

    Seattle, Washington 98104
    United States

    Site Not Available

  • Multicare Health System ( Site 2713)

    Spokane, Washington 99204
    United States

    Site Not Available

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