Clinical trial NCT03256422 (phase 3, status: unknown status)
Conditions: hiv infections
ICD codes: Z21
Drugs: treatment discontinuation
SMILES: COC1=CC=CC=C1OC1=C(NS(=O)(=O)C2=CC=C(C=C2)C(C)(C)C)N=C(N=C1OCCO)C1=NC=CC=N1
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