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

Sponsor
University Hospital, Caen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06034938
Collaborator
Merck Sharp & Dohme LLC (Industry)
32
Enrollment
4
Locations
1
Arm
17
Anticipated Duration (Months)
8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-label, non-comparative, single arm pilot trialOpen-label, non-comparative, single arm pilot trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm DOR/3TC/TDF

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma HIV-RNA at 24-week [24 weeks from the switch to DOR/3TC/TDF]

      Number of copies/mL

    Secondary Outcome Measures

    1. Plasma HIV-RNA at 48-week [48 weeks from the switch to DOR/3TC/TDF]

      Number of copies/mL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Caen Caen France
    2 CHU Orléans Orléans France
    3 CHU Rouen Rouen France
    4 CH Tourcoing Tourcoing France

    Sponsors and Collaborators

    • University Hospital, Caen
    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT06034938
    Other Study ID Numbers:
    • MISP-RC_Parienti007
    First Posted:
    Sep 13, 2023
    Last Update Posted:
    Sep 13, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University Hospital, Caen
    doravirine
    M184 mutation
    Maintenance therapy
    PLWH
    Additional relevant MeSH terms:
    Tenofovir
    Lamivudine

    Study Results

    No Results Posted as of Sep 13, 2023