NCT04564547

Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.

Detailed description

Based on laboratory findings of decreased lymphocyte and CD4+ T-cell counts across the islatravir program and as described in protocol amendment 2 (approved 01-Dec-2021), participants in study Part 1 (double-blind treatment period) were unblinded, discontinued all study interventions, and switched to standard of care non-study antiretroviral (ART) therapy. Participants who received ISL + ulonivirine (Groups 1 to 3) may have then entered into an unblinded safety monitoring period and were monitored for ≥6 months. As specified in protocol amendment 2, study Parts 2 and 3 were no longer planned or initiated for any participant.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Islatravir	ISL capsule taken by mouth.
DRUG	Ulonivirine	Ulonivirine tablet taken by mouth.
DRUG	BIC/FTC/TAF	BIC/FTC/TAF tablet taken by mouth.
DRUG	Placebo to ISL	Placebo capsule matched to ISL taken by mouth.
DRUG	Placebo to Ulonivirine	Placebo tablet matched to ulonivirine taken by mouth.
DRUG	Placebo to BIC/FTC/TAF	Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Timeline

• Start date: 2021-03-09
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2020-09-25
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

23 sites across 3 countries: United States, France, Switzerland

Regulatory

• FDA-regulated drug study