Clinical trial NCT02212379 (phase 2, status: completed)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: raltegravir and etravirine
SMILES: CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection

          -  Age ≥ 45 years

          -  Naïve to integrase inhibitor and etravirine

          -  At least 6 months of stable antiretroviral therapy (ART) including a boosted protease
             inhibitor, whatever the number of combined drugs

          -  HIV-RNA plasma VL ≤ 50 copies/mL during the last 24 months prior to screening visit
             (Week-6/Week-4), documented by at least 4 time-points with no more than one blip in
             HIV-RNA plasma viral load between 51 and 200 copies/mL

          -  HIV-RNA plasma VL ≤ 50 copies/mL at screening visit (Week-6/Week-4)

          -  A genotype is available (on amplified DNA at Week-6/Week-4 Visit and/or on RNA in the
             medical history of the patient) and shows a virus sensitive to ETR OR no genotype is
             available (amplification failure on DNA at Week-6/Week-4 Visit and no genotype in the
             medical history of the patient), there are no virological failure on NNRTI in the
             medical history

          -  CD4+ lymphocytes > 200 cells/mm3

          -  Creatinine < 2.5 x ULN

          -  CPK (Creatine Phospho Kinase) < 6 ULN (Upper Limit of Normal)

          -  AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) < 5 ULN

          -  Hemoglobin > 10 g/dL

          -  Platelets > 100 000/mm3

          -  Negative urinary pregnancy test and use of efficient contraception for women of
             childbearing potential

          -  For French participants only: subject enrolled in or a beneficiary of a Social
             Security programme (State Medical Aid or AME is not a Social Security programme),
             article L1121-11 of the Public health code

          -  Patients with a coverage from a social health

          -  Signed informed consent

        Exclusion Criteria:

          -  Previous exposure to raltegravir or etravirine

          -  Presence of any documented integrase inhibitor mutation on DNA genotype at
             Week-6/Week-4 and/or on RNA in the medical history of the patient

          -  Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac

          -  HIV-2 infection

          -  Active viral hepatitis C requiring a specific treatment during the 24 months of the
             trial

          -  Patient with a history of non-compliance or irregular follow-up

          -  Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or antidiabetic
             treatment within the last 3 months prior the screening visit (Week-6 /Week-4)

          -  Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®),
             Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® -
             Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John's wort, Carbamazepine
             (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra™), Triazolam
             (Halcion®)

          -  Concomitant treatment using interferon, interleukins or any other immunotherapy or
             chemotherapy

          -  Concomitant prophylactic or curative treatment for an opportunistic infection

          -  All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly
             interfere with trial protocol compliance, adherence and/or trial treatment tolerance

          -  Subjects under judicial protection due to temporarily and slightly diminished mental
             or physical faculties, or under legal guardianship

          -  Subjects participating in another clinical trial evaluating different therapies and
             including an exclusion period that is still in force during the screening phase

          -  Pregnant women or breastfeeding women