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

Hiv Clinical Trial

Official title:
DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06034938
Study type Interventional
Source University Hospital, Caen
Contact Jean-Jacques Parienti, MD, PhD
Phone +33231064320
Email parienti-jj@chu-caen.fr
Status Not yet recruiting
Phase Phase 2
Start date December 1, 2023
Completion date May 1, 2025
View Details
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