A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

In brief

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Key facts

Study ID: NCT07266831
Run by: Merck Sharp & Dohme LLC
People needed: 570
Starts: 2025-12-18
Expected to finish: 2030-04-03
Last updated by the study team: 2026-08-04

Who can join

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

You may qualify if…

Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3.
Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.

You may not qualify if…

Has human immunodeficiency virus type 2 (HIV-2) infection.
Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.

Where it is running

Ruane Clinical Research Group, Inc. ( Site 1513) — Los Angeles, California, United States (enrolling)
Whitman-Walker Institute ( Site 1538) — Washington D.C., District of Columbia, United States (enrolling)
Midway Immunology and Research Center ( Site 1503) — Ft. Pierce, Florida, United States (enrolling)
Vivent Health ( Site 1519) — Denver, Colorado, United States (enrolling)
Orlando Immunology Center ( Site 1501) — Orlando, Florida, United States (enrolling)
CAN Community Health ( Site 1510) — Sarasota, Florida, United States (enrolling)
Triple O Research Institute ( Site 1505) — West Palm Beach, Florida, United States (enrolling)
Metro Infectious Diseases Consultants L.L.C. ( Site 1509) — Decatur, Georgia, United States (enrolling)
CAN Community Health- Miami Gardens ( Site 1549) — Miami Gardens, Florida, United States (enrolling)
Rush University Medical Center-Infectious Disease ( Site 1522) — Chicago, Illinois, United States (enrolling)
Henry Ford Hospital ( Site 1535) — Detroit, Michigan, United States (enrolling)
KC CARE Health Center ( Site 1506) — Kansas City, Missouri, United States (enrolling)
ID Care ( Site 1507) — Hillsborough, New Jersey, United States (enrolling)
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533) — Charlotte, North Carolina, United States (enrolling)
Regional Center for Infectious Diseases ( Site 1516) — Greensboro, North Carolina, United States (enrolling)
The Ohio State University ( Site 1536) — Columbus, Ohio, United States (enrolling)
University of Pennsylvania Perelman School of Medicine ( Site 1508) — Philadelphia, Pennsylvania, United States (enrolling)
Saint Hope Foundation, Inc. ( Site 1504) — Bellaire, Texas, United States (enrolling)
Prism Health North Texas, Oak Cliff Health Center ( Site 1514) — Dallas, Texas, United States (enrolling)
Mercer university, Department of internal medicine-Clinical Research ( Site 1512) — Macon, Georgia, United States (enrolling)
Texas Center for Infectious Disease Associates ( Site 1502) — Fort Worth, Texas, United States (enrolling)
DCOL Center for Clinical Research ( Site 1511) — Longview, Texas, United States (enrolling)
Harborview Medical Center ( Site 1526) — Seattle, Washington, United States (enrolling)
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102) — Caba, Buenos Aires, Argentina (enrolling)
Fundación Huesped ( Site 3100) — CABA, Buenos Aires, Argentina (enrolling)

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.