4 consecutive days on treatment followed by 3 days off treatment, in hiv patients

Conditions: HIV-1 Infection

Summary: evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in hiv-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads \> 50 cp/ml) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).

methods: open-label, multicentric, prospective, non-randomized, non-controlled trial to evaluate at 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in hiv-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads \> 50 cp/ml) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days). allocation: non-randomized endpoint classification: safety/efficacy study primary purpose: treatment enrollment: 100 patients

Eligibility criteria:
inclusion criteria: * • hiv-1 documented infection * age 18 years or older * hiv-1 viral load always ≤ 50 cp/ml for at least 12 months (with a minimum of 3 measures in the last 12 months, including screening) * cd4+ lymphocytes count \> 250/mm3, for at least 6 months * treatment with a stable regimen for at least 4 months prior to screening, containing 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (nrti) combined with, either 1 non-nucleoside reverse transcriptase inhibitor (nnrti), or 1 ritonavir-boosted protease inhibitor (pi/r). the list of accepted antiretroviral drugs is limited to : 1. nrti : tenofovir, emtricitabine, abacavir, lamivudine 2. pi/r : lopinavir/r, darunavir/r or atazanavir/r 3. nnrti : efavirenz, rilpivirine or etravirine. * exclusive antiretroviral 3 drug-therapy (no 4 drug-therapy) * a least one genotypic resistance test available (reverse transcriptase and/or protease amino acid sequence, according to on-going antiretroviral drugs) ; on each genotypic resistance test(s) available in medical history, susceptibility to every on-going antiretroviral drugs must be demonstrated * clearance of the creatinine \> 60 ml/min (mdrd) * asat and alat \< 3 uln * hemoglobin \> 10 g/dl * platelets count \> 100 000/mm3 * negative pregnancy test for potential child-bearing women and mechanical contraception for sexual intercourses * patient living in france and affiliated to a social security system * written informed consent exclusion criteria: * • hiv-2 infection * hbv infection (positive hbs antigen) or isolated positive hbc antibody * hcv infection requiring specific treatment during the 51 weeks of the trial * at least one known resistance to one of on-going antiretroviral drugs * exclusive antiretroviral 3 drug-therapy (no 4 drug-therapy) * no genotypic resistance test available * on-going either interferon, interleukin treatment, or every immuno- / chemo-therapy * progressive opportunistic infection, on-going treatment for opportunistic infection or tuberculosis * patient with irregular follow-up or with treatment adherence problems * any condition (alcohol, drug abuse...) compromising treatment adherence, treatment safety, and/or study adherence * progressive neurological disorders (meningitis, encephalitis, myelitis...) related to hiv infection or not * medical history of severe neuropsychiatric disorder, with insufficient treatment efficacy * subject under legal guardianship or incapacitation

Keywords: hiv-1 simplification, treatment discontinuation virological success four days a week