Clinical Trial

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

Study acronym: DOR

Recruiting Phase 2

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.

Summary

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2023-09-06.

Status change: Not Yet Recruiting → Recruiting 2025-07-21

Trial Details

NCT Number	NCT06034938
Lead Sponsor	University Hospital, Caen Collaborators: Merck Sharp & Dohme LLC
Conditions	Hiv
Enrollment	32 participants
Start Date	2024-02-08
Primary Completion	2026-04-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-24