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A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

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Trial Profile

A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2025

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At a glance

  • Drugs Doravirine/islatravir (Primary) ; Antiretrovirals
  • Indications HIV-1 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 10 Jul 2025 According to Merck & Co Media Release, data from this study were presented during the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
  • 10 Jul 2025 According to Merck & Co Media Release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for doravirine/islatravir (DOR/ISL). The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA). The NDA is based on findings at Week 48 of two pivotal Phase 3 clinical trials (MK-8591A-051 and MK-8591A-052).
  • 08 Jul 2025 According to a Merck & Co Media Release,data from this trial will be presented at the 13th International AIDS Society Conference on HIV Science (IAS 2025) taking place July 13-17, 2025, in Kigali, Rwanda.

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