Actively Recruiting
DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
Led by University Hospital, Caen · Updated on 2025-07-24
32
Participants Needed
4
Research Sites
116 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Caen
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU de Caen
Caen, France
Actively Recruiting
2
CHU Orléans
Orléans, France
Actively Recruiting
3
CHU Rouen
Rouen, France
Actively Recruiting
4
CH Tourcoing
Tourcoing, France
Actively Recruiting
Research Team
J
Jean-Jacques Parienti, MD, PhD
CONTACT
F
Francois Fournel, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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