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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Ruane Clinical Research Group, Inc. ( Site 1513), Los Angeles, California, United States
• Vivent Health ( Site 1519), Denver, Colorado, United States
• Whitman-Walker Institute ( Site 1538), Washington D.C., District of Columbia, United States
• Midway Immunology and Research Center ( Site 1503), Ft. Pierce, Florida, United States
• CAN Community Health- Miami Gardens ( Site 1549), Miami Gardens, Florida, United States
• Orlando Immunology Center ( Site 1501), Orlando, Florida, United States
• CAN Community Health ( Site 1510), Sarasota, Florida, United States
• Triple O Research Institute ( Site 1505), West Palm Beach, Florida, United States
• Metro Infectious Diseases Consultants L.L.C. ( Site 1509), Decatur, Georgia, United States
• Mercer university, Department of internal medicine-Clinical Research ( Site 1512), Macon, Georgia, United States
• Rush University Medical Center-Infectious Disease ( Site 1522), Chicago, Illinois, United States
• Henry Ford Hospital ( Site 1535), Detroit, Michigan, United States

+ 44 more sites.

Who to contact

Toll Free Number · 1-888-577-8839 · Trialsites@msd.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07266831.