RecruitingPhase 2NCT06034938

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

DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study

Sponsor

University Hospital, Caen

Enrollment

32 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

HIV

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria10

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

Interventions

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

Switch previous therapy with DOR/TDF/3TC

Locations(4)

CHU de Caen

Caen, France

CHU Orléans

Orléans, France

CHU Rouen

Rouen, France

CH Tourcoing

Tourcoing, France

View Full Details on ClinicalTrials.gov

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NCT06034938

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