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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
• Phase 1 (8 weeks) : switch of the third agent with dolutegravir(Tivicay®) 50 mg once a day.
• Phase 2 (48 weeks): combination with lamivudine (Epivir®) 300 mg once a day + dolutegravir (Tivicay®) 50 mg once a day. Only participants with plasma HIV RNA ≤ 50 cp/mL at Week 8 will continue on phase 2.
• Phase 2 (48 weeks): combination with lamivudine (Epivir®) 300 mg once a day + dolutegravir (Tivicay®) 50 mg once a day. Only participants with plasma HIV RNA ≤ 50 cp/mL at Week 8 will continue on phase 2.
Hôpital Avicenne
Bobigny, France
Hôpital Saint-André
Bordeaux, France
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis)
Virological failure is defined by plasma HIV RNA \> 50 cp/mL on 2 following samples at 2 to 4 weeks apart.
Time frame: from week 8 to week 56 (± 4 weeks)
Evolution of CD4 and CD8 lymphocytes count (analysis)
Evaluation was calculated as the CD4 count at the corresponding week minus the baseline CD4 count
Time frame: from week 8 to week 32 and week 56
Percentage of participants who discontinued the strategy of the trial for toxicity or with adverse event of grade 3 or 4 (analysis)
Time frame: week 56
Profile of resistance mutations in plasma in case of virological failure
Time frame: week 56
Percentage of participants with plasma HIV RNA < 1 cp/mL
Time frame: Day 0, week 8, week 32 and week 56
Influence of total DNA on the occurrence of virological failure or blip
Influence of total DNA at Day 0 on the occurrence of virological failure or blip
Time frame: from Day 0 to week 56
Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip
Time frame: week 56
Measure of adherence to treatment (self-reported)
Time frame: Day 0, week 4, week 8, week 32 and week 56
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Hôpital du Bocage
Dijon, France
Hôpital Pierre Zobda-Quitman
Fort de France, France
Hôpial Bicêtre
Le Kremelin Bicêtre, France
Hôpital Gui de Chaudiac
Montpellier, France
Hôpital de l'Hotel Dieu
Nantes, France
Hôpital Saint-Louis
Paris, France
Hôpital Saint-Antoine
Paris, France
...and 8 more locations
Measure of quality of life (self-reported)
Time frame: Day 0, week 8 and week 56
Comparison of Medico-economic substudy (analysis)
Evaluation of medico-economic aspects. Evaluate the direct medical cost related to dolutegravir and lamivudine versus the cost of the previous treatment.
Time frame: week 56
Sperm substudy measure of concentration
Measure of concentrations of dolutegravir and NRTI, and HIV RNA in semen at Week 8 and Week 32 in a subgroup of 20 participants
Time frame: Week 8 and week 32