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

Caen University Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Hiv

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06034938

MISP-RC_Parienti007

Details and patient eligibility

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Single arm DOR/3TC/TDF

Experimental group

Description:

Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks

Treatment:

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