Clinical trial NCT04776252: 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)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HIV-1 Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants with serious adverse events (SAEs)
timeFrame: Up to Week 198
measure: Participants who discontinued due to an adverse event (AE)
timeFrame: Up to Week 192
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pueblo Family Physicians ( Site 0010)
state: Arizona
city: Sacramento
country: United States
facility: One Community Health ( Site 0045)
state: California
city: Washington
country: United States
facility: Whitman-Walker Institute ( Site 0039)
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
state: District of Columbia
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center ( Site 0033)
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center ( Site 0017)
state: Florida
city: Orlando
country: United States
facility: Bliss Healthcare Services-Research ( Site 0030)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A ( Site 0031)
state: Florida
city: Savannah
country: United States
facility: Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)
state: Georgia
city: Chicago
country: United States
facility: Northstar Healthcare ( Site 0003)
state: Illinois
city: Kansas City
country: United States
facility: KC CARE Health Center-Clinical Trials ( Site 0012)
state: Missouri
city: Hillsborough
country: United States
facility: ID Care ( Site 0028)
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)
state: New York
city: Philadelphia
country: United States
facility: Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
state: Pennsylvania
city: Bellaire
country: United States
facility: St Hope Foundation ( Site 0041)
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
state: Texas
city: Fort Worth
country: United States
facility: Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center ( Site 0008)
state: Texas
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice ( Site 0700)
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital-IBAC ( Site 0702)
state: New South Wales
city: Murdock
country: Australia
facility: Fiona Stanley Hospital ( Site 0706)
state: Western Australia
city: Calgary
country: Canada
facility: Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Infectious Diseases Centre ( Site 0100)
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research ( Site 0105)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital ( Site 0104)
state: Ontario
city: Montreal
country: Canada
facility: Clinique de médecine Urbaine du Quartier Latin ( Site 0110)
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale lActuel ( Site 0108)
state: Quebec
city: Temuco
country: Chile
facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)
state: Araucania
city: Santiago
country: Chile
facility: Biomedica Research Group-Infectology ( Site 0201)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)
state: Region M. De Santiago
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC ( Site 0300)
state: Valle Del Cauca
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)
state: Alpes-Maritimes
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)
state: Bourgogne
city: Bordeaux
country: France
facility: CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)
state: Gironde
city: Toulouse
country: France
facility: CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)
state: Haute-Garonne
city: Rouen
country: France
facility: CHU Charles Nicolle-Inefectious disease ( Site 1506)
state: Haute-Normandie
city: Montpellier
country: France
facility: Hospital La Colombière ( Site 1518)
state: Herault
city: Bobigny
country: France
facility: Hôpital Avicenne ( Site 1502)
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)
state: Ile-de-France
city: Paris
country: France
facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)
state: Ile-de-France
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)
state: Loire-Atlantique
city: Tourcoing
country: France
facility: Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)
state: Nord
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)
state: Rhone
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
state: Niedersachsen
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
state: Lazio
city: Milano
country: Italy
facility: Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (
state: Lombardia
city: Milan
country: Italy
facility: Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)
state: Milano
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 0903)
state: Aichi
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital ( Site 0904)
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0901)
state: Tokyo
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 0906)
city: Christchurch
country: New Zealand
facility: Christchurch Hospital-Infectious Diseases ( Site 0800)
state: Canterbury
city: Wroclaw
country: Poland
facility: Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)
state: Dolnoslaskie
city: Ód
country: Poland
facility: WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)
state: Lodzkie
city: Warsaw
country: Poland
facility: Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)
state: Mazowieckie
city: Kemerovo
country: Russian Federation
facility: Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
state: Kemerovskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)
state: Krasnoyarskiy Kray
city: Saint Petersburg
country: Russian Federation
facility: Republican Clinical Infectious Hospital ( Site 2300)
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)
state: Moskva
city: Moscow
country: Russian Federation
facility: Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
state: Sankt-Peterburg
city: Smolensk
country: Russian Federation
facility: Smolensk Center for prevention and control of AIDS ( Site 2308)
state: Smolenskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)
state: Tatarstan, Respublika
city: Bloemfontein
country: South Africa
facility: Josha Research ( Site 2403)
state: Free State
city: Johannesburg
country: South Africa
facility: Ezintsha ( Site 2404)
state: Gauteng
city: Pretoria
country: South Africa
facility: Mediclinc Muelmed ( Site 2401)
state: Gauteng
city: Durban
country: South Africa
facility: King Edward VIII Hospital ( Site 2410)
state: Kwazulu-Natal
city: Durban
country: South Africa
facility: Wentworth Hospital ( Site 2400)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation ( Site 2402)
state: Western Cape
city: Elche
country: Spain
facility: Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
state: Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)
state: Barcelona
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)
state: Cataluna
city: Madrid
country: Spain
facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor ( Site 1906)
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-Internal Medicine ( Site 1904)
city: Basel
country: Switzerland
facility: University Hospital Basel-Infectiology ( Site 2002)
state: Aargau
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)
state: Geneve
city: st.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen ( Site 2001)
state: Sankt Gallen
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)
state: Ticino
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich ( Site 2000)
state: Zurich
city: Berne
country: Switzerland
facility: Inselspital Bern-Inselspital Infektiologie ( Site 2003)
city: East Sussex
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2104)
state: Brighton And Hove
city: Bristol
country: United Kingdom
facility: Southmead Hospital ( Site 2103)
state: Bristol, City Of
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 2102)
state: England
city: London
country: United Kingdom
facility: King's College Hospital ( Site 2101)
state: England
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital ( Site 2105)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: