CINAMMONA Study to Assess Cerebrospinal Fluid INflammatory Markers After Addition of Maraviroc to MONotherapy Darunavir/Ritonavir - The CINAMMON Study

Date de début de l'étude : 1 novembre 2012

Inclusion Criteria: Patient volunteers who meet all of the following criteria are eligible for this trial: male or female aged between 18 and 65 years has a documented HIV-1 infection has signed the Informed Consent Form voluntarily is willing to comply with the protocol requirements has an HIV-plasma viral load at screening <40 copies/mL (one off retesting for blips <200 copies/ml is allowed) has a CD4 cell count at Screening >200 cells/mm3 has been on a stable darunavir/ritonavir regimen 800/100 once daily alone for at least 12 weeks at Screening, and willing to remain on this; estimated glomerular filtration rate (by MDRD or CG methods) >60 ml/min at screening CCR5 tropic by geno2pheno assay performed at screening if female and of childbearing potential, she is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs); Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential if a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit Exclusion Criteria: Patients meeting 1 or more of the following criteria cannot be selected: is infected with HIV-2 is using any concomitant therapy disallowed as per SPC for the study drugs (section 5.2) has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions (must be discussed with the Investigator prior to enrolment):Stable cutaneous Kaposi's Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions) unlikely to require systemic therapy during the trial period Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed has acute viral hepatitis including, but not limited to, A, B, or C has chronic hepatitis B and/or C has received any investigational drug within 30 days prior to the trial drug administration Clinically significant allergy or hypersensitivity to any trial medication excipients If female, she is pregnant or breastfeeding Screening blood results with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed). Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN. Platelets of < 50 based on lumbar puncture examination at baseline. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.