Clinical Research Directory
Browse clinical research sites, groups, and studies.
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
537
Start Date
2023-03-08
Completion Date
2029-08-05
Last Updated
2025-10-23
Healthy Volunteers
Yes
Conditions
Interventions
DOR/ISL
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
BIC/FTC/TAF
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.
Placebo to DOR/ISL
Placebo tablet matched to DOR/ISL tablet taken by mouth.
Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
Locations (131)
Pueblo Family Physicians ( Site 5674)
Phoenix, Arizona, United States
Pacific Oaks Medical Group ( Site 5681)
Beverly Hills, California, United States
Ruane Clinical Research Group, Inc ( Site 5658)
Los Angeles, California, United States
Vivent Health ( Site 5694)
Denver, Colorado, United States
Washington Health Institute ( Site 5689)
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 5657)
Ft. Pierce, Florida, United States
AHF The Kinder Medical Group ( Site 5672)
Miami, Florida, United States
AHF South Beach ( Site 5663)
Miami Beach, Florida, United States
Orlando Immunology Center ( Site 5654)
Orlando, Florida, United States
CAN Community Health - Sarasota ( Site 5668)
Sarasota, Florida, United States
Triple O Research Institute, P.A ( Site 5666)
West Palm Beach, Florida, United States
Emory University and Grady Health System-Medicine ( Site 5690)
Atlanta, Georgia, United States
Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
Atlanta, Georgia, United States
Atlanta I.D. Group ( Site 5680)
Atlanta, Georgia, United States
Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
Decatur, Georgia, United States
Mercer University, Department of Internal Medicine ( Site 5655)
Macon, Georgia, United States
Rush University Medical Center-Infectious Disease ( Site 5671)
Chicago, Illinois, United States
University of Illinois at Chicago-Project WISH ( Site 5685)
Chicago, Illinois, United States
Howard Brown Health Center-Clinical Research ( Site 5665)
Chicago, Illinois, United States
Be Well Medical Center ( Site 5650)
Berkley, Michigan, United States
Henry Ford Hospital ( Site 5667)
Detroit, Michigan, United States
KC CARE Health Center-Clinical Trials ( Site 5670)
Kansas City, Missouri, United States
Jubilee Clinical Research ( Site 5679)
Las Vegas, Nevada, United States
Las Vegas Research Center ( Site 5691)
Las Vegas, Nevada, United States
ID Care ( Site 5676)
Hillsborough, New Jersey, United States
Saint Michael's Medical Center ( Site 5682)
Newark, New Jersey, United States
Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
New York, New York, United States
Jacobi Medical Center ( Site 5683)
The Bronx, New York, United States
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
Charlotte, North Carolina, United States
Regional Center for Infectious Diseases ( Site 5687)
Greensboro, North Carolina, United States
University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
Cincinnati, Ohio, United States
Central Texas Clinical Research ( Site 5661)
Austin, Texas, United States
St Hope Foundation ( Site 5659)
Bellaire, Texas, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A ( Site 5651)
Dallas, Texas, United States
AXCES Research - Texas - El Paso ( Site 5692)
El Paso, Texas, United States
Texas Centers for Infectious Disease Associates ( Site 5656)
Fort Worth, Texas, United States
DCOL Center for Clinical Research ( Site 5664)
Longview, Texas, United States
Fundación Huésped ( Site 5850)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
Mar del Plata, Buenos Aires, Argentina
Instituto CAICI SRL ( Site 5852)
Rosario, Santa Fe Province, Argentina
Fundación IDEAA ( Site 5851)
Buenos Aires, Argentina
Instituto Oulton ( Site 5853)
Córdoba, Argentina
Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
Hamilton, Ontario, Canada
Toronto General Hospital ( Site 5753)
Toronto, Ontario, Canada
Clinique Medicale lActuel ( Site 5752)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 5751)
Montreal, Quebec, Canada
Regina General Hospital ( Site 5754)
Regina, Saskatchewan, Canada
Clinica Universidad Catolica del Maule ( Site 5954)
Talca, Maule Region, Chile
Biomedica Research Group-Infectology ( Site 5951)
Santiago, Region M. de Santiago, Chile
Espacio Eme ( Site 5952)
Santiago, Region M. de Santiago, Chile
Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
Santiago, Region M. de Santiago, Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
Santiago, Region M. de Santiago, Chile
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
Temuco, Región de la Araucanía, Chile
Ciensalud Ips S A S ( Site 6050)
Barranquilla, Atlántico, Colombia
Clinica de la Costa S.A.S. ( Site 6055)
Barranquilla, Atlántico, Colombia
Hospital Universitario San Ignacio-Infectious ( Site 6053)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
Bogotá, Bogota D.C., Colombia
Fundación Valle del Lili ( Site 6052)
Cali, Valle del Cauca Department, Colombia
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
Santo Domingo de Guzman, Santo Domingo Province, Dominican Republic
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
Nice, Alpes-Maritimes, France
Tourcoing Hospital ( Site 6150)
Tourcoing, Nord, France
Hôpital Bichat - Claude-Bernard ( Site 6162)
Paris, France
Hôpital Saint Antoine ( Site 6158)
Paris, France
Hôpital Avicenne ( Site 6160)
Bobigny, Île-de-France Region, France
Hôpital Saint-Louis ( Site 6159)
Paris, Île-de-France Region, France
Pitie Salpetriere University Hospital ( Site 6156)
Paris, Île-de-France Region, France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
München, Bavaria, Germany
Universitaetsklinikum Freiburg ( Site 6256)
Freiburg, Brandenburg, Germany
Universitätsklinikum Bonn-Immunologie ( Site 6250)
Bonn, North Rhine-Westphalia, Germany
ICH Study Center GmbH & Co. KG ( Site 6259)
Hamburg, Germany
Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
Hamburg, Germany
CLINIPHARM ( Site 8352)
Guatemala City, Guatemala
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
Guatemala City, Guatemala
CELAN,S.A ( Site 8351)
Guatemala City, Guatemala
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
Haifa, Israel
Hadassah Medical Center-Infecious Disease ( Site 6752)
Jerusalem, Israel
Sheba Medical Center-HIV unit ( Site 6753)
Ramat Gan, Israel
Sourasky Medical Center ( Site 6754)
Tel Aviv, Israel
National Hospital Organization Nagoya Medical Center ( Site 6953)
Nagoya, Aichi-ken, Japan
Tokyo Medical University Hospital ( Site 6954)
Shinjuku-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
Shinjyuku-ku, Tokyo, Japan
National Hospital Organization Osaka National Hospital ( Site 6952)
Osaka, Japan
CCR KEMRI (Center for Clinical Research) ( Site 8652)
Nairobi, Nairobi City, Kenya
PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
Nairobi, Nairobi City, Kenya
KEMRI-CMR-RCTP ( Site 8650)
Kisumu, Kenya
Hospital Sultanah Bahiyah ( Site 7776)
Alor Star, Kedah, Malaysia
University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 7779)
George Town, Pulau Pinang, Malaysia
Sarawak General Hospital ( Site 7772)
Kuching, Sarawak, Malaysia
Hospital Selayang ( Site 7770)
Batu Caves, Selangor, Malaysia
Hospital Sungai Buloh ( Site 7778)
Sungai Buloh, Selangor, Malaysia
Hospital Kuala Lumpur ( Site 7773)
Kuala Lumpur, Malaysia
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
Mexico City, Mexico City, Mexico
Ponce Medical School Foundation Inc. ( Site 7452)
Ponce, Puerto Rico
Clinical Research Puerto Rico ( Site 7450)
San Juan, Puerto Rico
HOPE Clinical Research ( Site 7451)
San Juan, Puerto Rico
Josha Research ( Site 6652)
Bloemfontein, Free State, South Africa
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
Johannesburg, Gauteng, South Africa
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
Johannesburg, Gauteng, South Africa
Ezintsha-Clinical Research Site ( Site 6656)
Johannesburg, Gauteng, South Africa
Wentworth Hospital ( Site 6653)
Durban, KwaZulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic ( Site 6659)
Ladysmith, KwaZulu-Natal, South Africa
Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
Pietermaritzburg, KwaZulu-Natal, South Africa
Madibeng Centre for Research ( Site 6660)
Brits, North West, South Africa
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
Cape Town, Western Cape, South Africa
Desmond Tutu Health Foundation ( Site 6651)
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre ( Site 6650)
Paarl, Western Cape, South Africa
Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
Elche, Alicante, Spain
Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
Badalona, Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge ( Site 6360)
L'Hospitalet de Llobregat,Barcelona, Catalonia, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 6355)
Madrid, Spain
Hospital Universitario La Paz ( Site 6354)
Madrid, Spain
Hospital Universitario Virgen de la Victoria ( Site 6359)
Málaga, Spain
University Hospital Basel-Infectiology ( Site 8151)
Basel, Canton of Basel-City, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
Geneva, Canton of Geneva, Switzerland
HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
Bangkok, Bangkok, Thailand
Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
Chiang Mai, Thailand
Hacettepe Universite Hastaneleri ( Site 7650)
Altindağ, Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
Ankara, Turkey (Türkiye)
Southmead Hospital ( Site 7952)
Bristol, Bristol, City of, United Kingdom
Royal London Hospital ( Site 7951)
London, England, United Kingdom
The Hathersage Centre ( Site 7953)
Manchester, England, United Kingdom
King's College Hospital ( Site 7950)
London, London, City of, United Kingdom
The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
London, London, City of, United Kingdom