Randomized, Double-blind, Efficacy, and Safety Study of Doravirine/Islatravir (DOR/ISL) in Treatment-naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

• Status: Recruiting
• Trial end date: 2025-01-01

Summary

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

• Phase: Phase 3

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: 4'-ethynyl-2-fluoro-2'-deoxyadenosine; Emtricitabine; Emtricitabine tenofovir alafenamide; Islatravir; Tenofovir