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)
Running, not enrolling · Phase 3
Conditions studied: HIV-1 Infection
In brief
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.
Key facts
- Study ID
- NCT04776252
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 2000
- Starts
- 2021-09-15
- Expected to finish
- 2029-05-29
- Last updated by the study team
- 2025-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Is taking or is anticipated to require any prohibited therapies.
Where it is running
- One Community Health ( Site 0045) — Sacramento, California, United States
- Whitman-Walker Institute ( Site 0039) — Washington D.C., District of Columbia, United States
- Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002 — Washington D.C., District of Columbia, United States
- Midway Immunology and Research Center ( Site 0033) — Ft. Pierce, Florida, United States
- Orlando Immunology Center ( Site 0017) — Orlando, Florida, United States
- Bliss Healthcare Services-Research ( Site 0030) — Orlando, Florida, United States
- 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
- Northstar Healthcare ( Site 0003) — Chicago, Illinois, 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
- Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site — Philadelphia, Pennsylvania, United States
- St Hope Foundation ( Site 0041) — Bellaire, Texas, United States
- North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004) — Dallas, Texas, United States
- Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026) — Fort Worth, Texas, United States
- The Crofoot Research Center ( Site 0008) — Houston, Texas, United States
- Holdsworth House Medical Practice ( Site 0700) — Darlinghurst, New South Wales, Australia
- St Vincent's Hospital-IBAC ( Site 0702) — Sydney, New South Wales, Australia
- Fiona Stanley Hospital ( Site 0706) — Murdock, Western Australia, Australia
- Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106) — Calgary, Alberta, Canada
- Vancouver Infectious Diseases Centre ( Site 0100) — Vancouver, British Columbia, Canada
- Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109) — Hamilton, Ontario, Canada
- Maple Leaf Research ( Site 0105) — Toronto, Ontario, Canada
- Pueblo Family Physicians ( Site 0010) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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