Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
NCT ID: NCT04776252
Last Updated: 2025-12-23
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
2000 participants
INTERVENTIONAL
2021-09-15
2029-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MK-8591A
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.
MK-8591A
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks
Interventions
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MK-8591A
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks
Eligibility Criteria
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Inclusion Criteria
* Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
* Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)
Exclusion Criteria
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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Pueblo Family Physicians ( Site 0010)
Phoenix, Arizona, United States
One Community Health ( Site 0045)
Sacramento, California, United States
Whitman-Walker Institute ( Site 0039)
Washington D.C., District of Columbia, United States
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 0033)
Ft. Pierce, Florida, United States
Orlando Immunology Center ( Site 0017)
Orlando, Florida, United States
Bliss Healthcare Services-Research ( Site 0030)
Orlando, Florida, United States
Triple O Research Institute, P.A ( Site 0031)
West Palm Beach, Florida, United States
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)
Savannah, Georgia, United States
Northstar Healthcare ( Site 0003)
Chicago, Illinois, United States
KC CARE Health Center-Clinical Trials ( Site 0012)
Kansas City, Missouri, United States
ID Care ( Site 0028)
Hillsborough, New Jersey, United States
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)
New York, New York, United States
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
Philadelphia, Pennsylvania, United States
St Hope Foundation ( Site 0041)
Bellaire, Texas, United States
North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
Dallas, Texas, United States
Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)
Fort Worth, Texas, United States
The Crofoot Research Center ( Site 0008)
Houston, Texas, United States
Holdsworth House Medical Practice ( Site 0700)
Darlinghurst, New South Wales, Australia
St Vincent's Hospital-IBAC ( Site 0702)
Sydney, New South Wales, Australia
Fiona Stanley Hospital ( Site 0706)
Murdock, Western Australia, Australia
Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
Calgary, Alberta, Canada
Vancouver Infectious Diseases Centre ( Site 0100)
Vancouver, British Columbia, Canada
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)
Hamilton, Ontario, Canada
Maple Leaf Research ( Site 0105)
Toronto, Ontario, Canada
Toronto General Hospital ( Site 0104)
Toronto, Ontario, Canada
Clinique de médecine Urbaine du Quartier Latin ( Site 0110)
Montreal, Quebec, Canada
Clinique Medicale lActuel ( Site 0108)
Montreal, Quebec, Canada
Biomedica Research Group-Infectology ( Site 0201)
Santiago, Region M. de Santiago, Chile
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)
Santiago, Region M. de Santiago, Chile
Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)
Santiago, Region M. de Santiago, Chile
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)
Temuco, Región de la Araucanía, Chile
Fundacion Valle del Lili- CIC ( Site 0300)
Cali, Valle del Cauca Department, Colombia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)
Nice, Alpes-Maritimes, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)
Dijon, Bourgogne-Franche-Comté, France
CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)
Bordeaux, Gironde, France
CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)
Toulouse, Haute-Garonne, France
CHU Charles Nicolle-Inefectious disease ( Site 1506)
Rouen, Haute-Normandie, France
Hospital La Colombière ( Site 1518)
Montpellier, Herault, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)
Nantes, Loire-Atlantique, France
Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)
Tourcoing, Nord, France
Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)
Lyon, Rhone, France
Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)
Paris, , France
Hôpital Avicenne ( Site 1502)
Bobigny, Île-de-France Region, France
Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)
Paris, Île-de-France Region, France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)
Paris, Île-de-France Region, France
Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
Hanover, Lower Saxony, Germany
Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
Rome, Lazio, Italy
Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)
Milan, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (
Pavia, Lombardy, Italy
Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)
Milan, Milano, Italy
National Hospital Organization Nagoya Medical Center ( Site 0903)
Nagoya, Aichi-ken, Japan
Tokyo Medical University Hospital ( Site 0904)
Shinjuku-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 0901)
Shinjyuku-ku, Tokyo, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09
Osaka, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 0906)
Tokyo, , Japan
Christchurch Hospital-Infectious Diseases ( Site 0800)
Christchurch, Canterbury, New Zealand
Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
Wroclaw, Lower Silesian Voivodeship, Poland
EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)
Wroclaw, Lower Silesian Voivodeship, Poland
Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)
Warsaw, Masovian Voivodeship, Poland
WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)
Ód, Łódź Voivodeship, Poland
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
Kemerovo, Kemerovo Oblast, Russia
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Republican Clinical Infectious Hospital ( Site 2300)
Saint Petersburg, Leningradskaya Oblast', Russia
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)
Moscow, Moscow, Russia
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)
Moscow, Moscow, Russia
Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
Saint Petersburg, Sankt-Peterburg, Russia
Smolensk Center for prevention and control of AIDS ( Site 2308)
Smolensk, Smolensk Oblast, Russia
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)
Kazan', Tatarstan, Respublika, Russia
Josha Research ( Site 2403)
Bloemfontein, Free State, South Africa
Ezintsha ( Site 2404)
Johannesburg, Gauteng, South Africa
Mediclinc Muelmed ( Site 2401)
Pretoria, Gauteng, South Africa
King Edward VIII Hospital ( Site 2410)
Durban, KwaZulu-Natal, South Africa
Wentworth Hospital ( Site 2400)
Durban, KwaZulu-Natal, South Africa
Desmond Tutu Health Foundation ( Site 2402)
Cape Town, Western Cape, South Africa
Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
Elche, Alicante, Spain
Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)
Badalona, Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)
Barcelona, Catalonia, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Infanta Leonor ( Site 1906)
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)
Madrid, , Spain
Hospital Universitario La Paz-Internal Medicine ( Site 1904)
Madrid, , Spain
University Hospital Basel-Infectiology ( Site 2002)
Basel, Canton of Aargau, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)
Geneva, Canton of Geneva, Switzerland
Cantonal Hospital St.Gallen ( Site 2001)
Sankt Gallen, Canton of St. Gallen, Switzerland
UniversitätsSpital Zürich ( Site 2000)
Zurich, Canton of Zurich, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)
Lugano, Canton Ticino, Switzerland
Inselspital Bern-Inselspital Infektiologie ( Site 2003)
Bern, , Switzerland
Brighton and Sussex University Hospitals NHS Trust ( Site 2104)
East Sussex, Brighton And Hove, United Kingdom
Southmead Hospital ( Site 2103)
Bristol, Bristol, City of, United Kingdom
Royal Free Hospital ( Site 2102)
London, England, United Kingdom
King's College Hospital ( Site 2101)
London, England, United Kingdom
North Manchester General Hospital ( Site 2105)
Manchester, , 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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jRCT2031210528
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-512215-53-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1304-7926
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-001191-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK-8591A-033
Identifier Type: OTHER
Identifier Source: secondary_id
8591A-033
Identifier Type: -
Identifier Source: org_study_id