NCT06034938RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 8 Feb 2024
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- University Hospital, Caen
- Diseases
- HIV
- NCT number
- NCT06034938
- EU CT number
- 2023-505845-17-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- From 8 Feb 2024 to the primary completion date, 1 Apr 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent treatment with a strong CYP3A4 inducer
Other illness
- History of genotypic mutation associated with resistance to DOR or TDF according to the ANRS version 32 algorithm, i.e. :
- Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular)
Other
- For DOR : V106A/M; Y188L; G190E/S; M230L; L100I + K103N; K103N + Y181C; K103N + P225H; F227C; At least 3 amongst: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
- For TDF : At least 3 mutations among: M41L, E44D, D67N, T69D/N/S, L74V/I, L210W, T215A/C/D/E/G/H/I/L/N/S/V/Y/F; K65R/E/N ; Insertion at codon 69; K70E
- Contraindications to the use of DOR/TDF/3TC
- Breast-feeding
- Patients already on DOR
- Pregnant or breast-feeding women
- Patients under guardianship or trusteeship
Who the study is looking for
- Adult living with HIV
- Receiving stable antiretroviral treatment for at least 3 months
- HIV RNA VL\<50cp/mL for at least 6 months
- Presence of the M184V/I mutation in at least one previous genotype performed on plasma HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger technique)
- Signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire d'Orléans Coordinator of this site? Confirm its status | ORLEANS | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 10 | France | Recruiting |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Centre Hospitalier De Tourcoing Coordinator of this site? Confirm its status | Tourcoing Cedex | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.