At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Islatravir, Ulonivirine, and 4 other interventions for HIV-1 Infection. Completed, enrolled 161 participants across 23 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
ISL capsule taken by mouth.
Ulonivirine tablet taken by mouth.
BIC/FTC/TAF tablet taken by mouth.
Placebo capsule matched to ISL taken by mouth.
Placebo tablet matched to ulonivirine taken by mouth.
Placebo tablet matched to BIC/FTC/TAF taken by mouth.