A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA or EPZICOM/KIVEXA, in Treatment-Naive HIV-1 Infected Subjects

Trial Profile

A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA or EPZICOM/KIVEXA, in Treatment-Naive HIV-1 Infected Subjects

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Mar 2018

At a glance

  • Drugs Doravirine (Primary) ; Darunavir; Emtricitabine/tenofovir disoproxil fumarate; Lamivudine/abacavir; Ritonavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms DRIVE-FORWARD
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 13 Mar 2018 Planned End Date changed from 18 Aug 2019 to 23 Jun 2021.
    • 08 Jan 2018 According to a Merck & co media release, the U.S. Food and Drug Administration (FDA) has accepted for review New Drug Application (NDA) for doravirine, as a once-daily tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. NDA application was based on data from this trial.
    • 19 Sep 2017 Planned End Date changed from 18 Sep 2017 to 18 Aug 2019.
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