A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Running, not enrolling · Phase 3

Conditions studied: HIV Infection

In brief

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Key facts

Study ID

NCT05766501

Run by

Merck Sharp & Dohme LLC

People needed

641

Starts

2023-03-17

Expected to finish

2028-09-06

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

You may not qualify if…

• Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
• Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
• Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Where it is running

• Pueblo Family Physicians ( Site 3102) — Phoenix, Arizona, United States
• Pacific Oaks Medical Group ( Site 3123) — Beverly Hills, California, United States
• Kaiser Permanente ( Site 3124) — Los Angeles, California, United States
• Ruane Clinical Research Group, Inc ( Site 3126) — Los Angeles, California, United States
• Mills Clinical Research ( Site 3114) — Los Angeles, California, United States
• University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137) — Sacramento, California, United States
• Georgetown University Medical Center ( Site 3130) — Washington D.C., District of Columbia, United States
• Therafirst Medical Center ( Site 3110) — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center ( Site 3117) — Ft. Pierce, Florida, United States
• AHF The Kinder Medical Group ( Site 3108) — Miami, Florida, United States
• Floridian Clinical Research, LLC ( Site 3133) — Miami Lakes, Florida, United States
• Orlando Immunology Center ( Site 3106) — Orlando, Florida, United States
• Bliss Healthcare Services ( Site 3115) — Orlando, Florida, United States
• CAN Community Health - Sarasota ( Site 3118) — Sarasota, Florida, United States
• Triple O Research Institute, P.A ( Site 3116) — West Palm Beach, Florida, United States
• Augusta University-Infectious Diseases ( Site 3135) — Augusta, Georgia, United States
• Infectious Disease Specialists of Atlanta ( Site 3128) — Decatur, Georgia, United States
• Mercer university, Department of internal medicine-Clinical Research ( Site 3129) — Macon, Georgia, United States
• Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105) — Savannah, Georgia, United States
• KC CARE Health Center ( Site 3103) — Kansas City, Missouri, United States
• ID Care ( Site 3131) — Hillsborough, New Jersey, United States
• Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134) — 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 3121) — Bellaire, Texas, United States
• University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.