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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History