Status:
RECRUITING
DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hiv
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 suppre...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06034938
Start Date
February 8 2024
End Date
May 1 2026
Last Update
July 24 2025
Active Locations (4)
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1
CHU de Caen
Caen, France
2
CHU Orléans
Orléans, France
3
CHU Rouen
Rouen, France
4
CH Tourcoing
Tourcoing, France