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

Last updated: July 21, 2025
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

2

Condition

Hiv

Treatment

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

Clinical Study ID

NCT06034938
MISP-RC_Parienti007
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 onplasma HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger technique)

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • History of genotypic mutation associated with resistance to DOR or TDF according tothe 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, G190Aor 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

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
Phase: 2
Study Start date:
February 08, 2024
Estimated Completion Date:
May 01, 2026

Connect with a study center

  • CHU de Caen

    Caen,
    France

    Active - Recruiting

  • CHU Orléans

    Orléans,
    France

    Active - Recruiting

  • CHU Rouen

    Rouen,
    France

    Active - Recruiting

  • CH Tourcoing

    Tourcoing,
    France

    Active - Recruiting

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