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

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital, Caen
NCT06034938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * History of genotypic mutation associated with resistance to DOR or TDF according to the ANRS version 32 algorithm, i.e. : * 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 * Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular) * Current or recent treatment with a strong CYP3A4 inducer * Breast-feeding * Patients already on DOR * Pregnant or breast-feeding women * Patients under guardianship or trusteeship
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What it tests

  • Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
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Where

4 sites
CHU de Caen
Caen, France
CHU Orléans
Orléans, France
CHU Rouen
Rouen, France
CH Tourcoing
Tourcoing, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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