Hiv
Conditions
Keywords
doravirine, M184 mutation, Maintenance therapy, PLWH
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.
Interventions
DRUGDoravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
Switch previous therapy with DOR/TDF/3TC
Sponsors
Merck Sharp & Dohme LLC
University Hospital, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, non-comparative, single arm pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma HIV-RNA at 24-week | 24 weeks from the switch to DOR/3TC/TDF | Number of copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma HIV-RNA at 48-week | 48 weeks from the switch to DOR/3TC/TDF | Number of copies/mL |
Countries
France
Contacts
Primary ContactJean-Jacques Parienti, MD, PhD
Backup ContactFrancois Fournel, MSc
Outcome results
None listed