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

Recruiting · NCT06034938 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Caen

View the official record on ClinicalTrials.gov →

Hiv

Interventions studied

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

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

4 locations listed.

CHU de Caen - Caen, France
CHU Orléans - Orléans, France
CHU Rouen - Rouen, France
CH Tourcoing - Tourcoing, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →