DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
NCT ID: NCT05705349
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
537 participants
INTERVENTIONAL
2023-03-08
2029-08-05
Brief Summary
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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
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks.
DOR/ISL
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
* If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Exclusion Criteria
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior 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 consent except for adequately 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 tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
18 Years
ALL
Yes
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 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
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2022-502099-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031220720
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1283-2516
Identifier Type: REGISTRY
Identifier Source: secondary_id
8591A-053
Identifier Type: -
Identifier Source: org_study_id
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