drugset / Trial / NCT06891066

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

NCT06891066

Phase 2 Active not recruiting 150 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.

Timeline

Start
2025-04-14
Primary completion
2027-08-10
Completion
2031-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator BIC Unknown 50 mg Oral
Comparator FTC Unknown 200 mg Oral
Subject Islatravir Other / unclassified 2 mg Oral
Comparator TAF Unknown 25 mg Oral
Subject Ulonivirine Small molecule 200 mg Oral