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

Hiv Clinical Trial

— DOR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06034938
• Other study ID #: MISP-RC_Parienti007
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Caen
• Contact: Jean-Jacques Parienti, MD, PhD
• Phone: +33231064320
• Email: parienti-jj[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: May 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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

Locations

Country	Name	City	State
France	CHU de Caen	Caen
France	CHU Orléans	Orléans
France	CHU Rouen	Rouen
France	CH Tourcoing	Tourcoing

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma HIV-RNA at 24-week	Number of copies/mL	24 weeks from the switch to DOR/3TC/TDF
Secondary	Plasma HIV-RNA at 48-week	Number of copies/mL	48 weeks from the switch to DOR/3TC/TDF