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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, non-comparative, single arm pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm DOR/3TC/TDF<br>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]<br>* Switch previous therapy with DOR/TDF/3TC<br>* Other names: Delstrigo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HIV-RNA at 24-week | Number of copies/mL | 24 weeks from the switch to DOR/3TC/TDF | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HIV-RNA at 48-week | Number of copies/mL | 48 weeks from the switch to DOR/3TC/TDF | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLWH, doravirine, M184 mutation, Maintenance therapy