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)

Phase 3

Active, not recruiting

• Conditions: HIV-1 Infection
• Interventions: Drug: MK-8591A

• 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

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2021-09-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2027-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

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