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ClinicalTrials.gov ID

NCT06034938

Lead Sponsor

University Hospital, CaenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

32Estimated

Last Update Posted

Jul 24, 2025Actual

Start Date

Feb 8, 2024Actual

Primary Completion Date

Apr 1, 2026Estimated

Completion Date

May 1, 2026Estimated

Official Title

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

Brief 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.

• Hiv

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, CaenOTHER

Collaborators

Merck Sharp & Dohme LLCINDUSTRY

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