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)

Last updated: July 8, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Hiv/aids

Hiv Infections

Treatment

BIC/FTC/TAF

DOR/ISL

Placebo to DOR/ISL

Clinical Study ID

NCT04233879
8591A-020
MK-8591A-020
2019-000590-23
jRCT2031210024
  • Ages > 18
  • All Genders

Study Summary

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is human immunodeficiency virus type 1 (HIV-1) positive

  • Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days ofprior therapy with any antiretroviral agent following a diagnosis of HIV-1 infectionincluding prevention of mother-to-child transmission up to 1 month prior toscreening.

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions applies: 1) Is not awoman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptablecontraceptive method, or be abstinent from heterosexual intercourse as theirpreferred and usual lifestyle (abstinent on a long term and persistent basis); 3) 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; 4) If a urine test cannot be confirmed as negative (eg, an ambiguousresult), a serum pregnancy test is required

Exclusion

Exclusion Criteria:

  • Has HIV-2 infection

  • Has hypersensitivity or other contraindication to any of the components of the studyinterventions as determined by the investigator

  • Has an active diagnosis of hepatitis due to any cause, including active HBVinfection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis Bvirus deoxyribonucleic acid [HBV DNA]-positive)

  • 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

  • Has a history or current evidence of any condition (including active tuberculosisinfection), therapy, laboratory abnormality or other circumstance (including drug oralcohol use or dependence) that might, in the opinion of the investigator, confoundthe results of the study or interfere with the participant's participation for thefull duration of the study

  • Has been treated for a viral infection other than HIV-1, such as hepatitis B, withan agent that is active against HIV-1

  • Is taking or is anticipated to require systemic immunosuppressive therapy, immunemodulators, or any prohibited therapy from 45 days prior to Day 1 through the studyintervention period

  • 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 studyintervention period

  • Has a documented or known virologic resistance to any approved HIV-1 reversetranscriptase inhibitor, or any study intervention

  • Has exclusionary laboratory values within 45 days prior to Day 1

  • Is female and is expecting to conceive or donate eggs at any time during the study

Study Design

Total Participants: 599
Treatment Group(s): 4
Primary Treatment: BIC/FTC/TAF
Phase: 3
Study Start date:
February 28, 2020
Estimated Completion Date:
January 29, 2025

Study Description

Double-blind treatment with the assigned intervention occurs from Day 1 to Week 96, followed by an open-label portion up to Week 144. Participants who benefit from treatment in the opinion of the Investigator may continue their assigned intervention up to Week 168 (or until they have the option to enroll in a DOR/ISL 100 mg/0.25 mg study, whichever is sooner).

Connect with a study center

  • IDEAA Foundation ( Site 5807)

    Buenos Aires, Caba C1405CKC
    Argentina

    Site Not Available

  • Fundación Huesped ( Site 5801)

    C.a.b.a, Caba C1202ABB
    Argentina

    Site Not Available

  • Helios Salud S.A. ( Site 5802)

    Ciudad Autonoma de Buenos Aires, Caba C1141ACG
    Argentina

    Site Not Available

  • Instituto CAICI ( Site 5803)

    Rosario, Santa Fe S2000PBJ
    Argentina

    Site Not Available

  • Instituto Oulton ( Site 5804)

    Cordoba, X5000JJS
    Argentina

    Site Not Available

  • Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)

    Hamilton, Ontario L8S 14K
    Canada

    Site Not Available

  • Toronto General Hospital - University Health Network ( Site 5705)

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • Clinique Medicale L Actuel ( Site 5714)

    Montreal, Quebec H2L 4P9
    Canada

    Site Not Available

  • McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Hospital Dr. Hernan Henriquez Aravena ( Site 5905)

    Temuco, Araucania 4781151
    Chile

    Site Not Available

  • Clinica Universidad Catolica del Maule ( Site 5909)

    Talca, Maule 3460000
    Chile

    Site Not Available

  • Centro Cardiovascular Cardiosur ( Site 5907)

    Santiago, Region M. De Santiago 8910259
    Chile

    Site Not Available

  • Clinica Arauco Salud ( Site 5900)

    Santiago, Region M. De Santiago 7560994
    Chile

    Site Not Available

  • Fundacion Arriaran ( Site 5901)

    Santiago, Region M. De Santiago 8360159
    Chile

    Site Not Available

  • Hospital Clinico de la Universidad Catolica ( Site 5903)

    Santiago, Region M. De Santiago 8331150
    Chile

    Site Not Available

  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)

    Bogota, Distrito Capital De Bogota 111321
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio ( Site 6005)

    Bogota, Distrito Capital De Bogota 110231
    Colombia

    Site Not Available

  • Fundacion Valle del Lili ( Site 6001)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

  • A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)

    Paris, Ain 75018
    France

    Site Not Available

  • Centre Hospitalier Regional du Orleans ( Site 6108)

    Orleans, Centre 45000
    France

    Site Not Available

  • Hopital Francois Mitterrand ( Site 6119)

    Dijon, Cote-d Or 21079
    France

    Site Not Available

  • CHU de Bordeaux. Hopital Pellegrin ( Site 6116)

    Bordeaux, Gironde 33076
    France

    Site Not Available

  • Centre Hospitalier de Tourcoing ( Site 6100)

    Tourcoing, Nord 59208
    France

    Site Not Available

  • Hopital de la Croix-Rousse ( Site 6127)

    Lyon, Rhone-Alpes 69004
    France

    Site Not Available

  • Hopital Avicenne ( Site 6102)

    Bobigny, Seine-Saint-Denis 93000
    France

    Site Not Available

  • A.P.H. Paris, Hopital Saint Louis ( Site 6114)

    Paris, 75010
    France

    Site Not Available

  • Hopital Pitie Salpetriere ( Site 6111)

    Paris, 75013
    France

    Site Not Available

  • Hopital Saint-Antoine ( Site 6113)

    Paris, 75012
    France

    Site Not Available

  • Universitaetsklinik Freiburg ( Site 6206)

    Freiburg, Baden-Wurttemberg 79106
    Germany

    Site Not Available

  • Klinikum der LMU München ( Site 6204)

    Muenchen, Bayern 80336
    Germany

    Site Not Available

  • MVZ Munchen am Goetheplatz ( Site 6202)

    Muenchen, Bayern 80337
    Germany

    Site Not Available

  • Infektiologikum ( Site 6201)

    Frankfurt am Main, Hessen 60596
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn ( Site 6200)

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)

    Berlin, 10787
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)

    Hamburg, 20246
    Germany

    Site Not Available

  • Rambam Medical Center ( Site 6701)

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Ein Kerem Medical Center ( Site 6702)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Chaim Sheba Medical Center. ( Site 6704)

    Ramat-Gan, 5265601
    Israel

    Site Not Available

  • Kaplan Medical Center ( Site 6700)

    Rehovot, 7610001
    Israel

    Site Not Available

  • Sourasky Medical Center ( Site 6705)

    Tel Aviv, 64239
    Israel

    Site Not Available

  • A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)

    Modena, Emilia-Romagna 41124
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII ( Site 6411)

    Bergamo, Lombardia 24127
    Italy

    Site Not Available

  • Ospedale San Gerardo ASST Monza ( Site 6412)

    Monza, Monza E Brianza 20900
    Italy

    Site Not Available

  • Ospedale Amedeo di Savoia ( Site 6414)

    Torino, Piemonte 10149
    Italy

    Site Not Available

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)

    Milano, 20157
    Italy

    Site Not Available

  • Azienda Ospedaliera San Paolo ( Site 6403)

    Milano, 20142
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)

    Milano, 20122
    Italy

    Site Not Available

  • Salute San Raffaele ( Site 6402)

    Milano, 20127
    Italy

    Site Not Available

  • IRCCS Policlinico San Matteo ( Site 6410)

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)

    Pescara, 65129
    Italy

    Site Not Available

  • Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)

    Roma, 00149
    Italy

    Site Not Available

  • National Hospital Organization Nagoya Medical Center ( Site 6903)

    Nagoya, Aichi 460-0001
    Japan

    Site Not Available

  • Kumamoto University Hospital ( Site 6905)

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69

    Osaka, 540-0006
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine ( Site 6901)

    Tokyo, 162-8655
    Japan

    Site Not Available

  • Tokyo Medical University Hospital ( Site 6904)

    Tokyo, 160-0023
    Japan

    Site Not Available

  • JOSHA Research ( Site 6605)

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Chris Hani Baragwanath Hospital - ICU ( Site 6608)

    Johannesburg, Gauteng 1862
    South Africa

    Site Not Available

  • Ezintsha ( Site 6609)

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)

    Johannesburg, Gauteng 2041
    South Africa

    Site Not Available

  • Wentworth Hospital ( Site 6607)

    Durban, Kwazulu-Natal 4052
    South Africa

    Site Not Available

  • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)

    Cape Town, Western Cape 7500
    South Africa

    Site Not Available

  • Be Part Yoluntu Centre ( Site 6603)

    Mbekweni, Paarl, Western Cape 7646
    South Africa

    Site Not Available

  • Hospital General de Elche ( Site 6308)

    Elche, Alicante 03202
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol ( Site 6301)

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge ( Site 6312)

    LHospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Clinic i Provincial ( Site 6300)

    Barcelona, Cataluna 08036
    Spain

    Site Not Available

  • Hospital Vall D Hebron ( Site 6302)

    Barcelona, Cataluna 08035
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon ( Site 6303)

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 6305)

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 6304)

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria ( Site 6309)

    Malaga, 29010
    Spain

    Site Not Available

  • Kaohsiung Veterans General Hospital ( Site 7102)

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 7101)

    Tainan, 70403
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 7100)

    Taipei, 100
    Taiwan

    Site Not Available

  • University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)

    Birmingham, Alabama 35222
    United States

    Site Not Available

  • Pueblo Family Physicians ( Site 5606)

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Ruane Clinical Research Group, Inc. ( Site 5624)

    Los Angeles, California 90036
    United States

    Site Not Available

  • Midway Immunology and Research ( Site 5622)

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Floridian Clinical Research, LLC ( Site 5625)

    Hialeah, Florida 33016
    United States

    Site Not Available

  • The Kinder Medical Group ( Site 5615)

    Miami, Florida 33133
    United States

    Site Not Available

  • Floridian Clinical Research, LLC ( Site 5625)

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 5613)

    Orlando, Florida 32803
    United States

    Site Not Available

  • CAN Community Health ( Site 5627)

    Sarasota, Florida 34237
    United States

    Site Not Available

  • Triple O Research Institute, P.A. ( Site 5621)

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Columbus Regional Research Institute ( Site 5616)

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Infectious Disease Specialists Of Atlanta PC ( Site 5608)

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Kansas City CARE Clinic ( Site 5607)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • University of Pennsylvania ( Site 5630)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Saint Hope Foundation, Inc. ( Site 5629)

    Bellaire, Texas 77401
    United States

    Site Not Available

  • North Texas ID Consultants, PA ( Site 5604)

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Centers for Infectious Disease Associates P.A. ( Site 5619)

    Fort Worth, Texas 76104
    United States

    Site Not Available

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