Trial Profile

A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1

Status: Not yet recruiting

Phase of Trial: Phase II/III

Latest Information Update: 25 Feb 2026

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At a glance

Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Islatravir (Primary) ; Ulonivirine (Primary)
Indications HIV-1 infections
Focus Adverse reactions; Therapeutic Use
Sponsors Merck Sharp & Dohme

17 Feb 2026 Planned primary completion date changed from 5 Oct 2029 to 12 Apr 2029.
11 Dec 2025 New trial record

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