DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Last updated: October 18, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hiv/aids

Hiv Infections

Treatment

Placebo to BIC/FTC/TAF

Placebo to DOR/ISL

DOR/ISL

Clinical Study ID

NCT05705349
8591A-053
jRCT2031220720
2022-502099-22-00
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening

  • Is naïve to antiretroviral therapy (ART) defined as having received no prior therapywith any antiretroviral agent following a diagnosis of HIV-1 infection

  • If female, is not a participant of childbearing potential (POCBP); or if a POCBP, isnot pregnant or breastfeeding, and is willing to use an acceptable contraceptivemethod or abstain from heterosexual intercourse for study duration

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 a diagnosis of an active AIDS-defining opportunistic infection within 30 daysprior to screening

  • Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).

  • Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis

  • Has a history of malignancy ≤5 years prior to providing documented informed consentexcept for adequately treated basal cell or squamous cell skin cancer, in situcervical 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 drugor alcohol use or dependence) that might, in the opinion of the investigator,confound the results of the study or interfere with the participant's participationfor the full duration of the study, such that it is not in the best interest of theparticipant to participate

Study Design

Total Participants: 500
Treatment Group(s): 4
Primary Treatment: Placebo to BIC/FTC/TAF
Phase: 3
Study Start date:
March 08, 2023
Estimated Completion Date:
August 05, 2029

Connect with a study center

  • Fundación Huésped ( Site 5850)

    Caba, Buenos Aires C1427CEA
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)

    Mar del Plata, Buenos Aires B7600FZO
    Argentina

    Site Not Available

  • Instituto CAICI SRL ( Site 5852)

    Rosario, Santa Fe S2000PBJ
    Argentina

    Site Not Available

  • Fundación IDEAA ( Site 5851)

    Buenos Aires, C1405CKC
    Argentina

    Site Not Available

  • Instituto Oulton ( Site 5853)

    Cordoba, X5000JJS
    Argentina

    Site Not Available

  • Hamilton Health Sciences-Urgent Care Centre ( Site 5750)

    Hamilton, Ontario L8S 1A4
    Canada

    Site Not Available

  • Toronto General Hospital ( Site 5753)

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Clinique Medicale lActuel ( Site 5752)

    Montréal, Quebec H2L 4P9
    Canada

    Site Not Available

  • McGill University Health Centre ( Site 5751)

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Regina General Hospital ( Site 5754)

    Regina, Saskatchewan S4P 0W5
    Canada

    Site Not Available

  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)

    Temuco, Araucania 4781151
    Chile

    Site Not Available

  • Clinica Universidad Catolica del Maule ( Site 5954)

    Talca, Maule 3465584
    Chile

    Site Not Available

  • Biomedica Research Group-Infectology ( Site 5951)

    Santiago, Region M. De Santiago 7500710
    Chile

    Site Not Available

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)

    Santiago, Region M. De Santiago 8330034
    Chile

    Site Not Available

  • Espacio Eme ( Site 5952)

    Santiago, Region M. De Santiago 7770086
    Chile

    Site Not Available

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)

    Santiago, Region M. De Santiago 8380420
    Chile

    Site Not Available

  • Ciensalud Ips S A S ( Site 6050)

    Barranquilla, Atlantico 08001
    Colombia

    Site Not Available

  • Clinica de la Costa S.A.S. ( Site 6055)

    Barranquilla, Atlantico 080020
    Colombia

    Site Not Available

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)

    Bogota, Distrito Capital De Bogota 111321
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio-Infectious ( Site 6053)

    Bogota, Distrito Capital De Bogota 110231
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio-Infectious ( Site 6053)

    Bogotá, Distrito Capital De Bogota 110231
    Colombia

    Site Not Available

  • Fundación Valle del Lili ( Site 6052)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

  • Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)

    Santo Domingo De Guzman, Santo Domingo 10305
    Dominican Republic

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)

    Nice, Alpes-Maritimes 06202
    France

    Site Not Available

  • Hôpital Avicenne ( Site 6160)

    Bobigny, Ile-de-France 93000
    France

    Site Not Available

  • Hôpital Saint-Louis ( Site 6159)

    Paris, Ile-de-France 75010
    France

    Site Not Available

  • Pitie Salpetriere University Hospital ( Site 6156)

    Paris, Ile-de-France 75013
    France

    Site Not Available

  • Tourcoing Hospital ( Site 6150)

    Tourcoing, Nord 59200
    France

    Site Not Available

  • Hôpital Bichat - Claude-Bernard ( Site 6162)

    Paris, 75018
    France

    Site Not Available

  • Hôpital Saint Antoine ( Site 6158)

    Paris, 75571
    France

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio

    München, Bayern 80336
    Germany

    Site Not Available

  • Universitaetsklinikum Freiburg ( Site 6256)

    Freiburg, Brandenburg 79106
    Germany

    Site Not Available

  • Universitätsklinikum Bonn-Immunologie ( Site 6250)

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • ICH Study Center GmbH & Co. KG ( Site 6259)

    Hamburg, 20146
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)

    Hamburg, 20246
    Germany

    Site Not Available

  • CELAN,S.A ( Site 8351)

    Guatemala, 01010
    Guatemala

    Site Not Available

  • CLINIPHARM ( Site 8352)

    Guatemala, 01001
    Guatemala

    Site Not Available

  • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)

    Guatemala, 01009
    Guatemala

    Site Not Available

  • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center-Infecious Disease ( Site 6752)

    Jerusalem, 9120
    Israel

    Site Not Available

  • Sheba Medical Center-HIV unit ( Site 6753)

    Ramat Gan, 5262100
    Israel

    Site Not Available

  • Sourasky Medical Center ( Site 6754)

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • National Hospital Organization Nagoya Medical Center ( Site 6953)

    Nagoya, Aichi 460-0001
    Japan

    Site Not Available

  • Tokyo Medical University Hospital ( Site 6954)

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine ( Site 6951)

    Shinjyuku-ku, Tokyo 162-8655
    Japan

    Site Not Available

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

    Osaka, 540-0006
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital ( Site 6952)

    Osaka, 540-0006
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital. ( Site 6952)

    Osaka, 540-0006
    Japan

    Site Not Available

  • CCR KEMRI (Center for Clinical Research) ( Site 8652)

    Nairobi, Nairobi City 00200
    Kenya

    Site Not Available

  • PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)

    Nairobi, Nairobi City 00202
    Kenya

    Site Not Available

  • KEMRI-CMR-RCTP ( Site 8650)

    Kisumu, 40100
    Kenya

    Site Not Available

  • Hospital Sultanah Bahiyah ( Site 7776)

    Alor Setar, Kedah 05460
    Malaysia

    Site Not Available

  • University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)

    Lembah Pantai, Kuala Lumpur 59100
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang ( Site 7779)

    George Town, Pulau Pinang 10450
    Malaysia

    Site Not Available

  • Sarawak General Hospital ( Site 7772)

    Kuching, Sarawak 93586
    Malaysia

    Site Not Available

  • Hospital Selayang ( Site 7770)

    Batu Caves, Selangor 68100
    Malaysia

    Site Not Available

  • Hospital Sungai Buloh ( Site 7778)

    Sungai Buloh, Selangor 47000
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur ( Site 7773)

    Kuala Lumpur, 50586
    Malaysia

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)

    Mexico City, Distrito Federal 14080
    Mexico

    Site Not Available

  • Ponce Medical School Foundation Inc. ( Site 7452)

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico ( Site 7450)

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • HOPE Clinical Research ( Site 7451)

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Josha Research ( Site 6652)

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Ezintsha-Clinical Research Site ( Site 6656)

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)

    Johannesburg, Gauteng 2092
    South Africa

    Site Not Available

  • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Wentworth Hospital ( Site 6653)

    Durban, Kwazulu-Natal 4052
    South Africa

    Site Not Available

  • Qhakaza Mbokodo Research Clinic ( Site 6659)

    Ladysmith, Kwazulu-Natal 3370
    South Africa

    Site Not Available

  • Human Sciences Research Council-Centre for Community Based Research ( Site 6664)

    Pietermaritzburg, Kwazulu-Natal 3201
    South Africa

    Site Not Available

  • Madibeng Centre for Research ( Site 6660)

    Brits, North-West 0250
    South Africa

    Site Not Available

  • Desmond Tutu Health Foundation ( Site 6651)

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)

    Cape Town, Western Cape 7500
    South Africa

    Site Not Available

  • Be Part Yoluntu Centre ( Site 6650)

    Paarl, Western Cape 7626
    South Africa

    Site Not Available

  • Hospital General Universitario de Elche-Infectius Disease ( Site 6358)

    Elche, Alicante 03202
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)

    Barcelona, Cataluna 08036
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge ( Site 6360)

    L'Hospitalet De Llobregat,Barcelona, Cataluna 08907
    Spain

    Site Not Available

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)

    Madrid, Madrid, Comunidad De 28007
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 6355)

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)

    Madrid, 28015
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 6354)

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria ( Site 6359)

    Malaga, 29010
    Spain

    Site Not Available

  • University Hospital Basel-Infectiology ( Site 8151)

    Basel, Basel-Stadt 4031
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)

    Genève, Geneve 1205
    Switzerland

    Site Not Available

  • Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Site Not Available

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)

    Bangkok, Krung Thep Maha Nakhon 10330
    Thailand

    Site Not Available

  • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Hacettepe Universite Hastaneleri ( Site 7650)

    Altindağ, Ankara 06230
    Turkey

    Site Not Available

  • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)

    Ankara, 06800
    Turkey

    Site Not Available

  • Southmead Hospital ( Site 7952)

    Bristol, Bristol, City Of BS10 5NB
    United Kingdom

    Site Not Available

  • Royal London Hospital ( Site 7951)

    London, England E1 1BB
    United Kingdom

    Site Not Available

  • The Hathersage Centre ( Site 7953)

    Manchester, England M13 0FH
    United Kingdom

    Site Not Available

  • King's College Hospital ( Site 7950)

    London, London, City Of SE5 9RL
    United Kingdom

    Site Not Available

  • The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)

    London, London, City Of WC1E 6JB
    United Kingdom

    Site Not Available

  • Pueblo Family Physicians ( Site 5674)

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Pacific Oaks Medical Group ( Site 5681)

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Ruane Clinical Research Group, Inc ( Site 5658)

    Los Angeles, California 90036
    United States

    Site Not Available

  • Vivent Health ( Site 5694)

    Denver, Colorado 80246
    United States

    Site Not Available

  • Washington Health Institute ( Site 5689)

    Washington, District of Columbia 20017
    United States

    Site Not Available

  • Midway Immunology and Research Center ( Site 5657)

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • AHF The Kinder Medical Group ( Site 5672)

    Miami, Florida 33133
    United States

    Site Not Available

  • AHF South Beach ( Site 5663)

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 5654)

    Orlando, Florida 32803
    United States

    Site Not Available

  • CAN Community Health - Sarasota ( Site 5668)

    Sarasota, Florida 34237
    United States

    Site Not Available

  • Triple O Research Institute, P.A ( Site 5666)

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Atlanta I.D. Group ( Site 5680)

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Emory University and Grady Health System-Medicine ( Site 5690)

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Infectious Disease Specialists of Atlanta ( Site 5653)

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • Metro Infectious Diseases Consultants L.L.C. ( Site 5653)

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Mercer University, Department of Internal Medicine ( Site 5655)

    Macon, Georgia 31201
    United States

    Site Not Available

  • Howard Brown Health Center-Clinical Research ( Site 5665)

    Chicago, Illinois 60613
    United States

    Site Not Available

  • Rush University Medical Center-Infectious Disease ( Site 5671)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois at Chicago-Project WISH ( Site 5685)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Be Well Medical Center ( Site 5650)

    Berkley, Michigan 48072
    United States

    Site Not Available

  • Henry Ford Hospital ( Site 5667)

    Detroit, Michigan 48202
    United States

    Site Not Available

  • KC CARE Health Center-Clinical Trials ( Site 5670)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Jubilee Clinical Research ( Site 5679)

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Las Vegas Research Center ( Site 5691)

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • ID Care ( Site 5676)

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • Saint Michael's Medical Center ( Site 5682)

    Newark, New Jersey 07102
    United States

    Site Not Available

  • Jacobi Medical Center ( Site 5683)

    Bronx, New York 10461
    United States

    Site Not Available

  • Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)

    New York, New York 10032
    United States

    Site Not Available

  • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Regional Center for Infectious Diseases ( Site 5687)

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)

    Cincinnati, Ohio 45267-0405
    United States

    Site Not Available

  • Central Texas Clinical Research ( Site 5661)

    Austin, Texas 78705
    United States

    Site Not Available

  • St Hope Foundation ( Site 5659)

    Bellaire, Texas 77401
    United States

    Site Not Available

  • North Texas Infectious Diseases Consultants, P.A ( Site 5651)

    Dallas, Texas 75246
    United States

    Site Not Available

  • Prism Health North Texas, Oak Cliff Health Center ( Site 5660)

    Dallas, Texas 75208
    United States

    Site Not Available

  • AXCES Research - Texas - El Paso ( Site 5692)

    El Paso, Texas 79902
    United States

    Site Not Available

  • Texas Centers for Infectious Disease Associates ( Site 5656)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • DCOL Center for Clinical Research ( Site 5664)

    Longview, Texas 75605
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.