NCT07266831

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

A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions

Type	Name	Description
DRUG	ISL	ISL 2 x 1 mg oral capsules administered qw for 96 weeks
DRUG	ULO	ULO 2 x 100 mg oral tablets administered qw for 96 weeks
DRUG	BIC/FTC/TAF	BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
DRUG	Placebo for BIC/FTC/TAF	BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
DRUG	Placebo to ISL/ULO	ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
DRUG	ISL/ULO	ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

Timeline

• Start date: 2025-12-18
• Primary completion: 2029-03-21
• Completion: 2030-04-03
• First posted: 2025-12-05
• Last updated: 2026-04-20

Locations

42 sites across 7 countries: United States, Argentina, Canada, France, Guatemala, South Africa, Spain

Regulatory

• FDA-regulated drug study