antiretroviral treatment taken 4 days per week versus continuous therapy 7/7 days per week in hiv-1 infected patients

Conditions: HIV Infections

Summary: the trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at w48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in hiv infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months.

open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at w48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in hiv infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months. the non-inferiority margin (delta) is 5%. the randomization will be stratified according to the family of the third antiretroviral agent (ii, pi, and nnrti). a minimum of 200 patients will be included in the integrase inhibitor strata to provide a sufficient power to assess the efficacy of strategy in this population. at w48, all patients with virological success in the continuous therapy group will switch to the 4/7 days therapy.

Eligibility criteria:
inclusion criteria: * hiv-1 infection, coinfection hiv-1/hiv-2 possible * age≥18 years old * current therapy unchanged for the last 4 months * receiving tritherapy with 2 nucleoside reverse transcriptase inhibitor+protease inhibitors or 2 nucleoside reverse transcriptase inhibitor+non-nucleoside reverse transcriptase inhibitors or 2 nucleoside reverse transcriptase inhibitor+integrase inhibitors. allowed treatment drugs are : 1. nucleoside analogs : tenofovir (tdf ou taf), emtricitabine, abacavir, lamivudine 2. protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r 3. non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine 4. integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir * viruses susceptible to all antiretroviral drugs present in the ongoing tritherapy (ac11-anrs algorithm). 1. if a genotype is available in the patient medical history; viruses must be susceptible to all ongoing antiretroviral drugs 2. if no rna genotype available, a genotype will be performed on dna at screening and will not have to show any resistance to the ongoing antiretroviral drugs * viral load (vl) \< 50 cp/ml in the past year, with at least 3 vl measurements including screening; only one episode of viral blip \< 200 copies/ml is authorized in the last year * cd4 t cells \> 250/mm3 at the screening visit * estimated glomerular filtration rate \> 60 ml/min (chronic kidney disease - epidemiology collaboration method) * transaminases : aspartate aminotransférase et alanine aminotransférase \< 3n * haemoglobin \> 10 g/dl * platelets \> 100 000/mm3 * for women of childbearing age, negative pregnancy test at screening; agree to use mechanical contraception during the study * social security system coverage * informed consent form signed by patient and investigator exclusion criteria: * infection by hiv-2 * chronic and active viral b hepatitis with positive antigen hbs * chronic and active viral c hepatitis with treatment expected in the next 98 weeks * concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitamink for patients on arvt using a booster * concomitant prophylactic or curative treatment for an opportunistic infection * all conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with study protocol compliance, observance and/or study treatment tolerance * pregnant or breast feeding women * subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship

Keywords: controlled, virological and therapeutic success, treatment discontinution, 4 days per week