The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection.
Phase III, randomized (1: 1), comparative, superiority, open-label, parallel assignment, national multicenter trial evaluating two treatments in patients with primary HIV-1 infection. Comparison of the two combinations regarding: * Viral reservoir at W48 * Early inhibition of viral replication, * Plasmatic and cellular cumulative viremia at W48, * Immune reconstitution with CD4, CD8 levels and CD4 / CD8 ratio, * Activation parameters decrease, * Adherence to treatments, * Treatments tolerance, * Adverse events, * Quality of life (by self-administered questionnaires). Study of the pharmacokinetics / dynamics relationship of the decay of plasma, cellular and spermatic compartments' viral loads. 50 participants per group will be enrolled in 40 sites in France. Co- inclusion in ANRS CO 06 PRIMO cohort will be offered
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Oral use, 50mg/day
Oral use, 800-150mg/day
Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg
Hopital Bicetre
All the Regions of the Country (40 Centers), France
HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48
Time frame: week 48
Cumulative cellular viremia up to week 48
Time frame: week 48
Cumulative plasmatic viremia (HIV-1 RNA) at week 48
Time frame: week 48
Cumulative plasmatic viremia using the values obtained by ultrasensitive quantification for all HIV-1-RNA values < 50 copies / mL.
Time frame: week 48
Levels of HIV-1 RNA in plasma at week 2, week 4, week 8, week 12, week 24, week 36, week 48 and changes between week 0 and week 48
Time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
Percentage of patients with HIV-1 RNA <50 copies / mL at week 2, week 4, week 8, week 12, week 24, week 36, week 48
Time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
Proportion of patients with HIV-1-RNA plasma below the ultrasensitive technique quantification threshold at week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Total DNA-HIV levels measured in PBMC at week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Total DNA-HIV levels measured in PBMC: changes between week 0 and week 48.
Time frame: between week 0 and week 48
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CD4 and CD8 counts and percentage at week 2, week 4, week 8, week 12, week 24, week 36, week 48.
Time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
CD4 and CD8 counts and percentage changes between week 0 and week 48.
Time frame: between week 0 and week 48.
CD4/CD8 ratio at week 2, week 4, week 8, week 12, week 24, week 36, week 48.
Time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
CD4/CD8 ratio changes between week 0 and week 48.
Time frame: between week 0 and week 48.
Pharmacokinetic: mean concentrations between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.
Time frame: between week 0 and week 48
Pharmacokinetic: cumulative AUC between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.
Time frame: between week 0 and week 48
Trial treatments tolerance using self-administered questionnaires of symptoms experienced.
Time frame: week 0, week 4, week 8, week 12, week 24, week 36 and week 48
Reported quality of life using self-administered questionnaire (PROQOL-HIV questionnaire).
Time frame: between week 0 and week 48
Number, nature and time of occurrence of stage 3 or 4 clinical and biological adverse events (using ANRS scale to grade severity of adverse events in adults).
Time frame: between week 0 and week 48
HIV infection progression defined by occurrence of B or C stage clinical events or death between week 0 and week 48
Time frame: between week 0 and week 48
Evolution of Metabolic disorders assessed by measurement of cholesterol, triglycerides, blood glucose and lipase
Time frame: between week 0 and week 48
Evolution of Renal function assessed by urea and serum creatinine.
Time frame: between week 0 and week 48
Adherence to treatments using self-administered questionnaires
Time frame: week 4, week 8, week 12, week 24, week 36 and week 48
Adherence to treatments using pills' counts by local pharmacist
Time frame: week 4, week 8, week 12, week 24 and week 36
Adherence to treatments using MEMS (Medical Event Monitoring System) data collected during the first 3 months
Time frame: between week 0 and week 12