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)

HIV-1 Infection Clinical Trial

Official title:

A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04776252
• Other study ID #: 8591A-033
• Secondary ID: MK-8591A-033jRCT
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: October 15, 2027

Study information

• Verified date: March 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: October 15, 2027
• Est. primary completion date: October 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV-1 Infection
• Infections

Intervention

Drug:
• MK-8591A
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice ( Site 0700)	Darlinghurst	New South Wales
Australia	Fiona Stanley Hospital ( Site 0706)	Murdock	Western Australia
Australia	St Vincent's Hospital-IBAC ( Site 0702)	Sydney	New South Wales
Canada	Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)	Calgary	Alberta
Canada	Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)	Hamilton	Ontario
Canada	Clinique de médecine Urbaine du Quartier Latin ( Site 0110)	Montreal	Quebec
Canada	Clinique Medicale lActuel ( Site 0108)	Montreal	Quebec
Canada	Maple Leaf Research ( Site 0105)	Toronto	Ontario
Canada	Toronto General Hospital ( Site 0104)	Toronto	Ontario
Canada	Vancouver Infectious Diseases Centre ( Site 0100)	Vancouver	British Columbia
Chile	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	Araucania
Colombia	Fundacion Valle del Lili- CIC ( Site 0300)	Cali	Valle Del Cauca
France	Hôpital Avicenne ( Site 1502)	Bobigny	Ile-de-France
France	CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)	Bordeaux	Gironde
France	Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)	Dijon	Bourgogne
France	Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)	Lyon	Rhone
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	Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)	Nice	Alpes-Maritimes
France	Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)	Paris
France	Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)	Paris	Ile-de-France
France	Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)	Paris	Ile-de-France
France	CHU Charles Nicolle-Inefectious disease ( Site 1506)	Rouen	Haute-Normandie
France	CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)	Toulouse	Haute-Garonne
France	Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)	Tourcoing	Nord
Germany	Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)	Hannover	Niedersachsen
Italy	Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)	Milan	Milano
Italy	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	Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)	Roma	Lazio
Japan	National Hospital Organization Nagoya Medical Center ( Site 0903)	Nagoya	Aichi
Japan	National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09	Osaka
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	Tokyo Metropolitan Komagome Hospital ( Site 0906)	Tokyo
New Zealand	Christchurch Hospital-Infectious Diseases ( Site 0800)	Christchurch	Canterbury
Poland	WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)	Ód	Lodzkie
Poland	Wojewódzki Szpital Zakazny w Warszawie ( Site 1702)	Warsaw	Mazowieckie
Poland	EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)	Wroclaw	Dolnoslaskie
Poland	Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)	Wroclaw	Dolnoslaskie
Russian Federation	Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)	Kazan	Tatarstan, Respublika
Russian Federation	Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)	Kemerovo	Kemerovskaya Oblast
Russian Federation	Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)	Krasnoyarsk	Krasnoyarskiy Kray
Russian Federation	Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)	Moscow	Moskva
Russian Federation	Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)	Moscow	Moskva
Russian Federation	Republican Clinical Infectious Hospital ( Site 2300)	Saint Petersburg	Leningradskaya Oblast
Russian Federation	Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact	Saint Petersburg	Sankt-Peterburg
Russian Federation	Smolensk Center for prevention and control of AIDS ( Site 2308)	Smolensk	Smolenskaya Oblast
South Africa	Josha Research ( Site 2403)	Bloemfontein	Free State
South Africa	Desmond Tutu Health Foundation ( Site 2402)	Cape Town	Western Cape
South Africa	King Edward VIII Hospital ( Site 2410)	Durban	Kwazulu-Natal
South Africa	Wentworth Hospital ( Site 2400)	Durban	Kwazulu-Natal
South Africa	Ezintsha ( Site 2404)	Johannesburg	Gauteng
South Africa	Mediclinc Muelmed ( Site 2401)	Pretoria	Gauteng
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	Cataluna
Spain	Hospital General Universitario de Elche-Infectius Disease ( Site 1908)	Elche	Alicante
Spain	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	Hospital Universitario Infanta Leonor ( Site 1906)	Madrid
Spain	Hospital Universitario La Paz-Internal Medicine ( Site 1904)	Madrid
Switzerland	University Hospital Basel-Infectiology ( Site 2002)	Basel	Aargau
Switzerland	Inselspital Bern-Inselspital Infektiologie ( Site 2003)	Berne
Switzerland	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	Cantonal Hospital St.Gallen ( Site 2001)	st.Gallen	Sankt Gallen
Switzerland	UniversitätsSpital Zürich ( Site 2000)	Zürich	Zurich
United Kingdom	Southmead Hospital ( Site 2103)	Bristol	Bristol, City Of
United Kingdom	Brighton and Sussex University Hospitals NHS Trust ( Site 2104)	East Sussex	Brighton And Hove
United Kingdom	King's College Hospital ( Site 2101)	London	England
United Kingdom	Royal Free Hospital ( Site 2102)	London	England
United Kingdom	North Manchester General Hospital ( Site 2105)	Manchester
United States	St Hope Foundation ( Site 0041)	Bellaire	Texas
United States	Northstar Healthcare ( Site 0003)	Chicago	Illinois
United States	North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)	Dallas	Texas
United States	Midway Immunology and Research Center ( Site 0033)	Fort Pierce	Florida
United States	Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)	Fort Worth	Texas
United States	ID Care ( Site 0028)	Hillsborough	New Jersey
United States	The Crofoot Research Center ( Site 0008)	Houston	Texas
United States	KC CARE Health Center-Clinical Trials ( Site 0012)	Kansas City	Missouri
United States	Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)	New York	New York
United States	Bliss Healthcare Services-Research ( Site 0030)	Orlando	Florida
United States	Orlando Immunology Center ( Site 0017)	Orlando	Florida
United States	Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site	Philadelphia	Pennsylvania
United States	Pueblo Family Physicians ( Site 0010)	Phoenix	Arizona
United States	One Community Health ( Site 0045)	Sacramento	California
United States	Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)	Savannah	Georgia
United States	Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002	Washington	District of Columbia
United States	Whitman-Walker Institute ( Site 0039)	Washington	District of Columbia
United States	Triple O Research Institute, P.A ( Site 0031)	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Colombia,  France,  Germany,  Italy,  Japan,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with serious adverse events (SAEs)	Percentage of participants with serious adverse events (SAEs)	Up to Week 198
Primary	Participants who discontinued due to an adverse event (AE)	Percentage of participants who discontinued study treatment due to an AE.	Up to Week 192

External Links

•   Merck Clinical Trials Information