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Clinical Trials in the UK / NCT04776252
Active, not recruiting Phase 3

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)

NCT04776252 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2021-09-15
Last updated
2025-12-23

Condition(s) studied

HIV-1 Infection

Investigational drug(s) / intervention(s)

MK-8591A

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
Pueblo Family Physicians ( Site 0010) Phoenix Arizona
One Community Health ( Site 0045) Sacramento California
Whitman-Walker Institute ( Site 0039) Washington D.C. District of Columbia
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002 Washington D.C. District of Columbia
Midway Immunology and Research Center ( Site 0033) Ft. Pierce Florida
Orlando Immunology Center ( Site 0017) Orlando Florida
Bliss Healthcare Services-Research ( Site 0030) Orlando Florida
Triple O Research Institute, P.A ( Site 0031) West Palm Beach Florida
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015) Savannah Georgia
Northstar Healthcare ( Site 0003) Chicago Illinois
KC CARE Health Center-Clinical Trials ( Site 0012) Kansas City Missouri
ID Care ( Site 0028) Hillsborough New Jersey
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006) New York New York
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site Philadelphia Pennsylvania
St Hope Foundation ( Site 0041) Bellaire Texas
North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004) Dallas Texas
Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026) Fort Worth Texas
The Crofoot Research Center ( Site 0008) Houston Texas
Holdsworth House Medical Practice ( Site 0700) Darlinghurst New South Wales
St Vincent's Hospital-IBAC ( Site 0702) Sydney New South Wales
Fiona Stanley Hospital ( Site 0706) Murdock Western Australia
Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106) Calgary Alberta
Vancouver Infectious Diseases Centre ( Site 0100) Vancouver British Columbia
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109) Hamilton Ontario
Maple Leaf Research ( Site 0105) Toronto Ontario
Toronto General Hospital ( Site 0104) Toronto Ontario
Clinique de médecine Urbaine du Quartier Latin ( Site 0110) Montreal Quebec
Clinique Medicale lActuel ( Site 0108) Montreal Quebec
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202) Temuco Araucania
Biomedica Research Group-Infectology ( Site 0201) Santiago Region M. de Santiago
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204) Santiago Region M. de Santiago
Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200) Santiago Region M. de Santiago
Fundacion Valle del Lili- CIC ( Site 0300) Cali Valle del Cauca Department
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504) Nice Alpes-Maritimes
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516) Dijon Bourgogne-Franche-Comté
CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512) Bordeaux Gironde
CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505) Toulouse Haute-Garonne
CHU Charles Nicolle-Inefectious disease ( Site 1506) Rouen Haute-Normandie
Hospital La Colombière ( Site 1518) Montpellier Herault
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517) Nantes Loire-Atlantique

+ 53 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04776252 on ClinicalTrials.gov ↗ ← All trials in the UK