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)
- Registration Number
- NCT04776252
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
- 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)
- Is taking or is anticipated to require any prohibited therapies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-8591A MK-8591A Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.
- Primary Outcome Measures
Name Time Method Participants who discontinued due to an adverse event (AE) Up to Week 192 Percentage of participants who discontinued study treatment due to an AE.
Participants with serious adverse events (SAEs) Up to Week 198 Percentage of participants with serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (93)
One Community Health ( Site 0045)
🇺🇸Sacramento, California, United States
Whitman-Walker Institute ( Site 0039)
🇺🇸Washington, District of Columbia, United States
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
🇺🇸Washington, District of Columbia, United States
Midway Immunology and Research Center ( Site 0033)
🇺🇸Fort Pierce, Florida, United States
Orlando Immunology Center ( Site 0017)
🇺🇸Orlando, Florida, United States
Bliss Healthcare Services-Research ( Site 0030)
🇺🇸Orlando, Florida, 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
St Hope Foundation ( Site 0041)
🇺🇸Bellaire, Texas, United States
Holdsworth House Medical Practice ( Site 0700)
🇦🇺Darlinghurst, New South Wales, Australia
Vancouver Infectious Diseases Centre ( Site 0100)
🇨🇦Vancouver, British Columbia, Canada
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, France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)
🇫🇷Paris, Ile-de-France, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)
🇫🇷Nantes, Loire-Atlantique, France
Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)
🇫🇷Lyon, Rhone, France
Center Hospital of the National Center for Global Health and Medicine ( Site 0901)
🇯🇵Shinjyuku-ku, Tokyo, Japan
Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
🇵🇱Wroclaw, Dolnoslaskie, Poland
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)
🇪🇸Madrid, Spain
North Manchester General Hospital ( Site 2105)
🇬🇧Manchester, United Kingdom
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
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
🇺🇸Philadelphia, Pennsylvania, United States
North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
🇺🇸Dallas, Texas, United States
The Crofoot Research Center ( Site 0008)
🇺🇸Houston, Texas, United States
Maple Leaf Research ( Site 0105)
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital ( Site 0104)
🇨🇦Toronto, Ontario, Canada
Ezintsha ( Site 2404)
🇿🇦Johannesburg, Gauteng, South Africa
Royal Free Hospital ( Site 2102)
🇬🇧London, England, United Kingdom
King's College Hospital ( Site 2101)
🇬🇧London, England, United Kingdom
Fiona Stanley Hospital ( Site 0706)
🇦🇺Murdock, Western Australia, Australia
Wentworth Hospital ( Site 2400)
🇿🇦Durban, Kwazulu-Natal, South Africa
King Edward VIII Hospital ( Site 2410)
🇿🇦Durban, Kwazulu-Natal, South Africa
Brighton and Sussex University Hospitals NHS Trust ( Site 2104)
🇬🇧East Sussex, Brighton And Hove, United Kingdom
Clinique de médecine Urbaine du Quartier Latin ( Site 0110)
🇨🇦Montreal, Quebec, Canada
EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)
🇵🇱Wrocław, Dolnoslaskie, Poland
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)
🇷🇺Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
🇷🇺Kemerovo, Kemerovskaya Oblast, Russian Federation
Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
🇨🇦Calgary, Alberta, Canada
Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)
🇪🇸Badalona, Barcelona, Spain
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)
🇨🇱Temuco, Araucania, Chile
National Hospital Organization Nagoya Medical Center ( Site 0903)
🇯🇵Nagoya, Aichi, Japan
Republican Clinical Infectious Hospital ( Site 2300)
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
Smolensk Center for prevention and control of AIDS ( Site 2308)
🇷🇺Smolensk, Smolenskaya Oblast, Russian Federation
CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)
🇫🇷Bordeaux, Gironde, France
Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)
🇨🇱Santiago, Region M. De Santiago, Chile
CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)
🇫🇷Toulouse, Haute-Garonne, France
WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)
🇵🇱Ód, Lodzkie, Poland
Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)
🇵🇱Warsaw, Mazowieckie, Poland
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)
🇷🇺Moscow, Moskva, Russian Federation
Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
🇪🇸Elche, Alicante, Spain
Cantonal Hospital St.Gallen ( Site 2001)
🇨🇭st.Gallen, Sankt Gallen, Switzerland
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09
🇯🇵Osaka, Japan
Tokyo Metropolitan Komagome Hospital ( Site 0906)
🇯🇵Tokyo, Japan
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)
🇷🇺Moscow, Moskva, Russian Federation
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Desmond Tutu Health Foundation ( Site 2402)
🇿🇦Cape Town, Western Cape, South Africa
Pueblo Family Physicians ( Site 0010)
🇺🇸Phoenix, Arizona, United States
Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (
🇮🇹Pavia, Lombardia, Italy
Northstar Healthcare ( Site 0003)
🇺🇸Chicago, Illinois, United States
Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)
🇺🇸Fort Worth, Texas, United States
St Vincent's Hospital-IBAC ( Site 0702)
🇦🇺Sydney, New South Wales, Australia
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)
🇨🇦Hamilton, Ontario, Canada
Clinique Medicale lActuel ( Site 0108)
🇨🇦Montreal, Quebec, Canada
Fundacion Valle del Lili- CIC ( Site 0300)
🇨🇴Cali, Valle Del Cauca, Colombia
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
Hospital La Colombière ( Site 1518)
🇫🇷Montpellier, Herault, France
CHU Charles Nicolle-Inefectious disease ( Site 1506)
🇫🇷Rouen, Haute-Normandie, France
Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)
🇫🇷Paris, Ile-de-France, France
Hôpital Avicenne ( Site 1502)
🇫🇷Bobigny, Ile-de-France, France
Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)
🇮🇹Milan, Milano, Italy
Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)
🇫🇷Paris, France
Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
🇩🇪Hannover, Niedersachsen, Germany
Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
🇮🇹Roma, Lazio, Italy
Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)
🇫🇷Tourcoing, Nord, France
Christchurch Hospital-Infectious Diseases ( Site 0800)
🇳🇿Christchurch, Canterbury, New Zealand
Tokyo Medical University Hospital ( Site 0904)
🇯🇵Shinjuku-ku, Tokyo, Japan
Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Josha Research ( Site 2403)
🇿🇦Bloemfontein, Free State, South Africa
Mediclinc Muelmed ( Site 2401)
🇿🇦Pretoria, Gauteng, South Africa
HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)
🇪🇸Barcelona, Cataluna, Spain
Hospital Universitario Infanta Leonor ( Site 1906)
🇪🇸Madrid, Spain
University Hospital Basel-Infectiology ( Site 2002)
🇨🇭Basel, Aargau, Switzerland
Hospital Universitario La Paz-Internal Medicine ( Site 1904)
🇪🇸Madrid, Spain
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)
🇨🇭Geneva, Geneve, Switzerland
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)
🇨🇭Lugano, Ticino, Switzerland
UniversitätsSpital Zürich ( Site 2000)
🇨🇭Zürich, Zurich, Switzerland
Southmead Hospital ( Site 2103)
🇬🇧Bristol, Bristol, City Of, United Kingdom
Inselspital Bern-Inselspital Infektiologie ( Site 2003)
🇨🇭Berne, Switzerland