NCT06034938 DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
| NCT ID | NCT06034938 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Caen |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2024-02-08 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06034938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06034938 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06034938 currently recruiting?
Yes, NCT06034938 is actively recruiting participants. Contact the research team at parienti-jj@chu-caen.fr for enrollment information.
Where is the NCT06034938 trial being conducted?
This trial is being conducted at Caen, France, Orléans, France, Rouen, France, Tourcoing, France.
Who is sponsoring the NCT06034938 clinical trial?
NCT06034938 is sponsored by University Hospital, Caen. The trial plans to enroll 32 participants.
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