QDISS Stud: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

Exclusion Criteria

• •HIV-2 co-infection
• •Concomitant treatments contra-indicated with raltegravir
• •Patients receiving raltegravir 400mg, 2 tablets in one daily intake
• •Patients with prior virological failure on NRTI+PI/r based regimen can be enrolled as long as historical plasma genotype and/or screening DNA genotype demonstrate absence of resistance or possible resistance to any drug. Subjects with previous failure to any other antiretroviral regimen cannot be enrolled.
• •Presence of possible resistance or resistance to any nucleoside reverse transcriptase inhibitor or integrase inhibitor on a historical plasma genotype.
• •Presence of possible resistance or resistance to any non- nucleoside reverse transcriptase inhibitor on a historical plasma genotype, with the exception of polymorphic mutations E138A/G/K/Q/R/S and V179D in patients naïve to NNRTI.
• •Presence of resistance to any PI on a historical plasma genotype
• •In case were historical plasma genotype being not available or incomplete, resistance genotype will be performed on DNA at screening visit. Full treatment and cumulative resistance genotype history will have to be provided, at screening, to the principal investigator to approve any inclusion.
• •For HCV co-infected patients, if specific treatment for hepatitis is required during the trial duration, such HCV therapy should be compatible with the ARV combination and only started after the W24 visit.
• •HBV infection, in the absence of treatment with TDF or TAF
• •Severe associated diseases requiring specific treatment, such as curative treatment of acute opportunistic infection
• •Treatment with interferon, interleukin or any immunotherapeutic agent or chemotherapy
• •Cancer diagnosis in the past 3 years with the exception of Kaposi sarcoma
• •Subjects participating in another clinical trial evaluating therapies and having an exclusion period that is still ongoing during the screening phase
• •Any condition which might compromise the safety of treatment and/or patient's adherence to trial procedures
• •Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
• •Difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation)