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NCT Number: NCT06034938

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Caen, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Switch previous therapy with DOR/TDF/3TC

Other names: Delstrigo

Primary outcomes

  1. Plasma HIV-RNA at 24-week

    Time frame: 24 weeks from the switch to DOR/3TC/TDF

    Number of copies/mL

Secondary outcomes

  1. Plasma HIV-RNA at 48-week

    Time frame: 48 weeks from the switch to DOR/3TC/TDF

    Number of copies/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Francois Fournel, MSc

CONTACT

[email protected]

Jean-Jacques Parienti, MD, PhD

CONTACT

[email protected]

+33231064320

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: DOR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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