4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients

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