There is one clinical trial.
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.
Inclusion Criteria: - HIV-1 infected patient - Age ≥ 18 years - CD4 cell count nadir > 200/mm3 - Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance group's algorithm which presents: - no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, 154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the mutation A98S if the patient is not infected by the virus subtype C), - no mutation on integrase (if the genotype is available), - First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or 1 INI). --- D30N --- --- V32I --- --- M46I --- --- I47A --- --- G48V --- --- I50L --- --- L76V --- --- V82A --- --- I84V --- --- N88D --- --- L90M --- --- A98S ---
Description: Virological failure is defined by plasma HIV RNA > 50 cp/mL on 2 following samples at 2 to 4 weeks apart.Measure: Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis) Time: from week 8 to week 56 (± 4 weeks)
Description: Evaluation was calculated as the CD4 count at the corresponding week minus the baseline CD4 countMeasure: Evolution of CD4 and CD8 lymphocytes count (analysis) Time: from week 8 to week 32 and week 56
Description: Influence of total DNA at Day 0 on the occurrence of virological failure or blipMeasure: Influence of total DNA on the occurrence of virological failure or blip Time: from Day 0 to week 56
Description: Evaluation of medico-economic aspects. Evaluate the direct medical cost related to dolutegravir and lamivudine versus the cost of the previous treatment.Measure: Comparison of Medico-economic substudy (analysis) Time: week 56
Description: Measure of concentrations of dolutegravir and NRTI, and HIV RNA in semen at Week 8 and Week 32 in a subgroup of 20 participantsMeasure: Sperm substudy measure of concentration Time: Week 8 and week 32