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

Phase 2

Not yet recruiting

• Conditions: Hiv
• Interventions: Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]

• Registration Number: NCT06034938
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Study Start: 2023-12-01
• Primary Completion: 2024-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm DOR/3TC/TDF	Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]	Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks

Primary Outcome Measures

Name	Time	Method
Plasma HIV-RNA at 24-week	24 weeks from the switch to DOR/3TC/TDF	Number of copies/mL

Secondary Outcome Measures

Name	Time	Method
Plasma HIV-RNA at 48-week	48 weeks from the switch to DOR/3TC/TDF	Number of copies/mL

Trial Locations

Locations (4)

CHU Orléans; 🇫🇷 Orléans, France

CHU de Caen; 🇫🇷 Caen, France

CHU Rouen; 🇫🇷 Rouen, France

CH Tourcoing; 🇫🇷 Tourcoing, France