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Recruiting NCT06034938

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

Phase II Interventional Hiv

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO].
Who it may be relevant to
Registry conditions: Hiv. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
    Switch previous therapy with DOR/TDF/3TC

Primary outcome measures

  • Plasma HIV-RNA at 24-week [Time frame: 24 weeks from the switch to DOR/3TC/TDF]
Secondary outcome measures (1)
  • Plasma HIV-RNA at 48-week [Time frame: 48 weeks from the switch to DOR/3TC/TDF]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 4 centers
  • CHU de Caen — Caen
  • CHU Orléans — Orléans
  • CHU Rouen — Rouen
  • CH Tourcoing — Tourcoing

Identifiers

NCT: NCT06034938 · MISP-RC_Parienti007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗