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

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.

NCT Number	NCT07266831
Lead Sponsor	Merck Sharp & Dohme LLC
Conditions	Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Enrollment	570 participants
Start Date	2025-12-18
Primary Completion	2029-03-21 (estimated)
Study Completion	2030-04-03 (estimated)
Updated on ClinicalTrials.gov	2026-08-10