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)
NCT ID: NCT04233879
Last Updated: 2026-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
599 participants
INTERVENTIONAL
2020-02-28
2025-01-29
Brief Summary
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A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
NCT05766501
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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Group 1: doravirine/islatravir (DOR/ISL)
Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
DOR/ISL
100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.
Placebo to BIC/FTC/TAF
Placebo single tablet matched to BIC/FTC/TAF taken by mouth.
Group 2: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
BIC/FTC/TAF
BIC/FTC/TAF 50/200/25 mg FDC single tablet taken once daily by mouth.
Placebo to DOR/ISL
Placebo single tablet matched to DOR/ISL taken by mouth.
Interventions
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DOR/ISL
100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.
BIC/FTC/TAF
BIC/FTC/TAF 50/200/25 mg FDC single tablet taken once daily by mouth.
Placebo to BIC/FTC/TAF
Placebo single tablet matched to BIC/FTC/TAF taken by mouth.
Placebo to DOR/ISL
Placebo single tablet matched to DOR/ISL 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 ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required
Exclusion Criteria
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or hepatitis B virus deoxyribonucleic acid \[HBV DNA\]-positive)
* Has a history of malignancy ≤5 years prior to signing 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
* Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period
* Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase 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
18 Years
ALL
No
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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University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)
Birmingham, Alabama, United States
Pueblo Family Physicians ( Site 5606)
Phoenix, Arizona, United States
Ruane Clinical Research Group, Inc. ( Site 5624)
Los Angeles, California, United States
Midway Immunology and Research ( Site 5622)
Ft. Pierce, Florida, United States
The Kinder Medical Group ( Site 5615)
Miami, Florida, United States
Floridian Clinical Research, LLC ( Site 5625)
Miami Lakes, Florida, United States
Orlando Immunology Center ( Site 5613)
Orlando, Florida, United States
CAN Community Health ( Site 5627)
Sarasota, Florida, United States
Triple O Research Institute, P.A. ( Site 5621)
West Palm Beach, Florida, United States
Columbus Regional Research Institute ( Site 5616)
Columbus, Georgia, United States
Infectious Disease Specialists Of Atlanta PC ( Site 5608)
Decatur, Georgia, United States
Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)
Minneapolis, Minnesota, United States
Kansas City CARE Clinic ( Site 5607)
Kansas City, Missouri, United States
University of Pennsylvania ( Site 5630)
Philadelphia, Pennsylvania, United States
Saint Hope Foundation, Inc. ( Site 5629)
Bellaire, Texas, United States
North Texas ID Consultants, PA ( Site 5604)
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates P.A. ( Site 5619)
Fort Worth, Texas, United States
Helios Salud S.A. ( Site 5802)
Buenos Aires, Buenos Aires F.D., Argentina
IDEAA Foundation ( Site 5807)
Buenos Aires, Buenos Aires F.D., Argentina
Fundación Huesped ( Site 5801)
C.a.b.a, Buenos Aires F.D., Argentina
Instituto CAICI ( Site 5803)
Rosario, Santa Fe Province, Argentina
Instituto Oulton ( Site 5804)
Córdoba, , Argentina
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)
Hamilton, Ontario, Canada
Toronto General Hospital - University Health Network ( Site 5705)
Toronto, Ontario, Canada
Clinique Medicale L Actuel ( Site 5714)
Montreal, Quebec, Canada
McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)
Montreal, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 5909)
Talca, Maule Region, Chile
Clinica Arauco Salud ( Site 5900)
Santiago, Region M. de Santiago, Chile
Hospital Clinico de la Universidad Catolica ( Site 5903)
Santiago, Region M. de Santiago, Chile
Fundacion Arriaran ( Site 5901)
Santiago, Region M. de Santiago, Chile
Centro Cardiovascular Cardiosur ( Site 5907)
Santiago, Region M. de Santiago, Chile
Hospital Dr. Hernan Henriquez Aravena ( Site 5905)
Temuco, Región de la Araucanía, Chile
Hospital Universitario San Ignacio ( Site 6005)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)
Bogotá, Bogota D.C., Colombia
Fundacion Valle del Lili ( Site 6001)
Cali, Valle del Cauca Department, Colombia
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)
Paris, Ain, France
Hopital de la Croix-Rousse ( Site 6127)
Lyon, Auvergne-Rhône-Alpes, France
Centre Hospitalier Regional du Orleans ( Site 6108)
Orléans, Centre-Val de Loire, France
Hopital Francois Mitterrand ( Site 6119)
Dijon, Cote-d Or, France
CHU de Bordeaux. Hopital Pellegrin ( Site 6116)
Bordeaux, Gironde, France
Centre Hospitalier de Tourcoing ( Site 6100)
Tourcoing, Nord, France
Hopital Avicenne ( Site 6102)
Bobigny, Seine-Saint-Denis, France
A.P.H. Paris, Hopital Saint Louis ( Site 6114)
Paris, , France
Hopital Saint-Antoine ( Site 6113)
Paris, , France
Hopital Pitie Salpetriere ( Site 6111)
Paris, , France
Universitaetsklinik Freiburg ( Site 6206)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Klinikum der LMU München ( Site 6204)
Munich, Bavaria, Germany
MVZ Munchen am Goetheplatz ( Site 6202)
Munich, Bavaria, Germany
Infektiologikum ( Site 6201)
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Bonn ( Site 6200)
Bonn, North Rhine-Westphalia, Germany
EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)
Berlin, , Germany
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)
Hamburg, , Germany
Rambam Medical Center ( Site 6701)
Haifa, , Israel
Hadassah Ein Kerem Medical Center ( Site 6702)
Jerusalem, , Israel
Chaim Sheba Medical Center. ( Site 6704)
Ramat Gan, , Israel
Kaplan Medical Center ( Site 6700)
Rehovot, , Israel
Sourasky Medical Center ( Site 6705)
Tel Aviv, , Israel
A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)
Napoli, Campania, Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)
Modena, Emilia-Romagna, Italy
ASST Papa Giovanni XXIII ( Site 6411)
Bergamo, Lombardy, Italy
Ospedale San Gerardo ASST Monza ( Site 6412)
Monza, Monza E Brianza, Italy
Ospedale Amedeo di Savoia ( Site 6414)
Turin, Piedmont, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)
Milan, , Italy
Salute San Raffaele ( Site 6402)
Milan, , Italy
Azienda Ospedaliera San Paolo ( Site 6403)
Milan, , Italy
ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)
Milan, , Italy
IRCCS Policlinico San Matteo ( Site 6410)
Pavia, , Italy
Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)
Pescara, , Italy
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)
Roma, , Italy
National Hospital Organization Nagoya Medical Center ( Site 6903)
Nagoya, Aichi-ken, Japan
Kumamoto University Hospital ( Site 6905)
Kumamoto, , Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69
Osaka, , Japan
Tokyo Medical University Hospital ( Site 6904)
Tokyo, , Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 6901)
Tokyo, , Japan
JOSHA Research ( Site 6605)
Bloemfontein, Free State, South Africa
Chris Hani Baragwanath Hospital - ICU ( Site 6608)
Johannesburg, Gauteng, South Africa
Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)
Johannesburg, Gauteng, South Africa
Ezintsha ( Site 6609)
Johannesburg, Gauteng, South Africa
Wentworth Hospital ( Site 6607)
Durban, KwaZulu-Natal, South Africa
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)
Cape Town, Western Cape, South Africa
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre ( Site 6603)
Mbekweni, Paarl, Western Cape, South Africa
Hospital General de Elche ( Site 6308)
Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol ( Site 6301)
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge ( Site 6312)
LHospitalet de Llobregat, Barcelona, Spain
Hospital Vall D Hebron ( Site 6302)
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial ( Site 6300)
Barcelona, Catalonia, Spain
Hospital General Universitario Gregorio Maranon ( Site 6303)
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)
Madrid, , Spain
Hospital Universitario 12 de Octubre ( Site 6305)
Madrid, , Spain
Hospital Universitario La Paz ( Site 6304)
Madrid, , Spain
Hospital Universitario Virgen de la Victoria ( Site 6309)
Málaga, , Spain
Kaohsiung Veterans General Hospital ( Site 7102)
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital ( Site 7101)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 7100)
Taipei, , Taiwan
Countries
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References
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Rockstroh JK, Paredes R, Cahn P, Molina JM, Sokhela SM, Hinestrosa F, Kassim S, Cunningham D, Ghosn J, Bogner JR, Gatanaga H, Asante-Appiah E, Zhang Y, Nwoke U, Klopfer SO, Eves K, Squires K, Correll T, Fox MC, Pisculli ML. Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial HIV-1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial. Clin Infect Dis. 2025 Sep 16;81(2):322-332. doi: 10.1093/cid/ciaf077.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8591A-020
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031210024
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-000590-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591A-020
Identifier Type: -
Identifier Source: org_study_id
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