Management of participants with low-level persistent viremia
Name: Protease inhibitor
Description: Modification in the antiretroviral treatment •Switch arm for protease inhibitor : intervention switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.Type: DrugSwitch arm for protease inhibitor
Name: Isentress® (raltegravir)
Description: • Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counselingType: DrugAddition of Isentress® (raltegravir)
Name: Counseling arm
Description: No change of antiretroviral treatment but only counselingType: OtherCounseling arm
Description: A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12.
Measure: Proportion of patients in Virologic success by week 12 Time: week 12Description: •Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count
Measure: Change in CD4 cells count from baseline Time: week 12, week 24, week 48 and end visitDescription: •resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA
Measure: Number of Participants With Virologic Failure and Emergence of Resistance Time: day 0 and visit at failure timeDescription: Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm
Measure: Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC) Time: day 0Description: •plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy
Measure: Levels of antiretroviral drugs in plasma Time: day 0 and end visitDescription: •measurement of concentrations of antiretroviral drugs treatments in hair
Measure: Levels of antiretroviral drugs in hair Time: day 0, week 12, week 24and end visitDescription: quantification of HIV RNA in seminal plasma
Measure: Levels of HIV-1 RNA in seminal plasma Time: day 0, week 12, week 48 and end visitDescription: •proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure
Measure: Incidence of Study interruption Time: From day 0 to week 24Description: • proportions of participants experiencing a clinical or biological adverse events (ANRS scale)
Measure: Incidence of clinical and biological adverse events Time: from day 0 to week 48Description: •self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks
Measure: Self-reported adherence Time: day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visitAllocation: Randomized
Parallel Assignment
There is one SNP
- Participant naïve to raltegravir (RAL) - failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation) - creatinin < 3 Upper Limit normal (ULN) - Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN) - hemoglobin > 8 g/dL - platelets > 50 000/mm3 - In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method - Informed consent - Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique) Exclusion Criteria: - HIV-2 infection, - severe medical condition in the last month (inclusion is possible for a stable condition at screening) - breastfeeding women, current pregnancy or planned pregnancy within 12 months. --- M184V ---