HIV-1 Infection Clinical Trial
Official title:
A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol
The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.
Secondary objectives:
The following parameters will be evaluated :
- Evolution of CD4 cells and CD8 cells
- Tolerance to treatment
- Emergence of resistance mutations at time of virological failure
- HIV viral load measured with ultrasensitive assay (threshold 1 copy/mL) at Day 0, Week
8, Week 32 and Week 56
- Influence of total DNA at Day 0 on the occurrence of virological failure or blip
- Plasma levels of dolutegravir(Tivicay®) and lamivudine in participants with virological
failure
- Adherence to treatment
- Quality of life
- Medico-economic aspects
- Dolutegravir(Tivicay®) and Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) levels,
and HIV viral load in semen in a subgroup of 20 participants.
Methodology:
Pilot trial, multicentric, national, prospective, no randomized and no comparative.
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