Efficacy of the Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine combination in people living with HIV with a history of M184V/I mutation and virologically controlled: a phase II, open-label, non-comparative pilot study.
- Conditions
- Patients living with HIV-1 who are virologically controlled and carry an M184V/I mutation in a previous genotypeMedDRA version: 20.1Level: LLTClassification code: 10020160Term: HIV disease Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
Adult patient living with HIV-1, 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 (at least 6 months undetectable), but absent from the genotype on current standard proviral DNA (Sanger technique), Signed informed consent
M184V/I mutation present at inclusion on the standard proviral DNA genotype (Sanger technique), Renal failure with CrCl < 50ml/min, History of genotypic mutation associated with resistance to DOR or TDF, Contraindication to the use of DOR/TDF/3TC, Hypersensitivity to doravirine, tenofovir, lamivudine or one of the excipients (notably lactose), Current or recent treatments with a strong CYP3A4 inducer, Feeding with milk, Pregnancy, Patient already under DOR, Patients under guardianship or curatorship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method