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Active (not recruiting) Phase 3 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)

Phase 3 – large-scale trial before approval
Conditions: HIV-1 Infection

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
Description
As of Amendment 12, participants will have the option to continue receiving DOR/ISL (100 mg/0.75 mg) until treatment alternatives are identified, or up to Week 288 given that participants are still deriving benefit, based on individual benefit/risk assessment.
Who can participate
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.
Locations 16
Australia (1)
Holdsworth House Medical Practice ( Site 0700)
Darlinghurst , New South Wales
Canada (1)
Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
Calgary , Alberta
Chile (1)
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)
Temuco , Araucania
Colombia (1)
Fundacion Valle del Lili- CIC ( Site 0300)
Cali , Valle del Cauca Department
France (1)
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)
Nice , Alpes-Maritimes
Germany (1)
Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
Hanover , Lower Saxony
Italy (1)
Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
Rome , Lazio
Japan (1)
National Hospital Organization Nagoya Medical Center ( Site 0903)
Nagoya , Aichi-ken
New Zealand (1)
Christchurch Hospital-Infectious Diseases ( Site 0800)
Christchurch , Canterbury
Poland (1)
Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
Wroclaw , Lower Silesian Voivodeship
Russia (1)
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
Kemerovo , Kemerovo Oblast
South Africa (1)
Josha Research ( Site 2403)
Bloemfontein , Free State
Spain (1)
Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
Elche , Alicante
Switzerland (1)
University Hospital Basel-Infectiology ( Site 2002)
Basel , Canton of Aargau
United Kingdom (1)
Brighton and Sussex University Hospitals NHS Trust ( Site 2104)
East Sussex , Brighton And Hove
United States (1)
Pueblo Family Physicians ( Site 0010)
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.09.2021
Completion date
29.05.2029
Registry ID
NCT04776252
Source
anzctr
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