At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
In Brief
A Phase 3 clinical trial evaluating ISL, DOR, and 3 other interventions for HIV-1 Infection. Completed, enrolled 35 participants across 98 sites in 18 countries.
Detailed Summary
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).
Study Details
Timeline
Interventions
ISL 0.75 mg capsule taken by mouth.
DOR 100 mg tablet taken by mouth.
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Placebo capsule matched to ISL taken by mouth.
Placebo tablet matched to DOR taken by mouth.