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DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)

Study acronym: DOR
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 24, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2024 to Apr 1, 2026
    • Study completion date: May 1, 2025 to May 1, 2026
    • Start date changed from estimate of Dec 1, 2023 to Feb 8, 2024
    • Site details revised at 4 of 4 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.
Trial Details
NCT Number NCT06034938
Lead Sponsor University Hospital, Caen
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Hiv
Related terms Acquired Immunodeficiency Syndrome
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov