DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Summary

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Timeline

Start

2023-03-08

Primary completion

2025-10-13

Completion

2029-08-05

Publications

• Rockstroh JK, Kassim S, Paredes R, Bettacchi C, Sinclair G, Avihingsanon A, Mugo N, Molina JM, Crabtree Ramirez B, Gatanaga H, Xu Y, Klopfer SO, Diamond TL, Vesnesky M, Stamm LM, Fox MC, Pisculli ML. Fixed-dose daily doravirine (100 mg) with islatravir (0.25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial. Lancet HIV. 2026 Feb 25:S2352-3018(26)00033-0. doi: 10.1016/S2352-3018(26)00033-0. Online ahead of print.

Drugs

Indications