RecruitingPhase 2NCT06034938

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

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

Sponsor

University Hospital, Caen

Enrollment

32 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

HIV

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a simplified HIV treatment combination (doravirine/tenofovir/lamivudine, known as DOR/TDF/3TC) works effectively for people living with HIV who have a specific drug resistance mutation (M184V/I) but still have an undetectable viral load on their current treatment. **You may be eligible if...** - You are an adult living with HIV - You have been on stable antiretroviral therapy for at least 3 months - Your HIV is undetectable (viral load under 50 copies/mL) for at least 6 months - A past genetic test showed the M184V/I resistance mutation in your virus **You may NOT be eligible if...** - You have resistance mutations that would reduce the effectiveness of doravirine or tenofovir - You are allergic to any of the drug components - You are currently taking a medication that strongly interferes with doravirine (CYP3A4 inducers) - You are pregnant or breastfeeding - You are already taking doravirine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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