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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Switch previous therapy with DOR/TDF/3TC
CHU de Caen
Caen, France
RECRUITINGCHU Orléans
Orléans, France
RECRUITINGCHU Rouen
Rouen, France
RECRUITINGCH Tourcoing
Tourcoing, France
RECRUITINGPlasma HIV-RNA at 24-week
Number of copies/mL
Time frame: 24 weeks from the switch to DOR/3TC/TDF
Plasma HIV-RNA at 48-week
Number of copies/mL
Time frame: 48 weeks from the switch to DOR/3TC/TDF
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