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

Launched by UNIVERSITY HOSPITAL, CAEN · Sep 6, 2023

Keywords

ClinConnect Summary

The "Drive Off-Road" clinical trial is studying a new combination of HIV medications called Doravirine (DOR), Lamivudine (3TC), and Tenofovir Disproxyl Fumarate (TDF). This trial is specifically for adults living with HIV who have had stable treatment for at least three months and whose virus levels have been controlled for at least six months. Participants must also have a specific mutation (M184V/I) that makes them resistant to 3TC, although this mutation should not be present in their current HIV DNA test.

If you qualify and decide to join, you will switch to the DOR/3TC/TDF combination and be monitored closely for 24 weeks to see how well it keeps your HIV suppressed. The study will continue monitoring you for a total of 48 weeks, looking at any changes in your weight, metabolism, and the HIV mutations over time. It’s important to know that this trial is not yet recruiting participants, and some people may not be eligible due to specific medical conditions or treatments.

Gender

ALL

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