DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
Key facts
- Where
- Caen Cedex 9, Montpellier Cedex 5, ORLEANS, Paris, Paris Cedex 10, Rouen Cedex, and Tourcoing Cedex, FranceSee the 8 sites
- Phase
- Phase 2
Where in France
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire d'OrléansORLEANS, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Hopital Saint LouisParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranceTaking people
- CHU De RouenRouen Cedex, FranceTaking people
- Centre Hospitalier De TourcoingTourcoing Cedex, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Caen
- Trial code
- NCT06034938EU 2023-505845-17-00
- Record updated
- 24 July 2025
- Original description
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.Read full original descriptionShow less
DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study
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.
Inclusion: 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.
Exclusion: Current or recent treatment with a strong CYP3A4 inducer; 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); 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.