MAraviroc In HIV/ HCV Coinfection and Liver fibrosis - maicol

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 个研究点开始时间: 2009年3月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Patient with documented HIV-1/HCV (HCV-RNA detectable at quantitative assay) co-infection
•2.Male or female ages > 18 years old
•3.Patients who have voluntarily signed and dated the CI
•4.Patients currently receiving a PI based HAART for at least 24 weeks based on Truvada plus Atazanavir 300 mg/ritonavir 100 mg QD
•5.Patients taking the same ARV combination for at least 8 weeks before enrolment
•6.Plasma HIV-RNA < 50 copies/ml in two consecutively examination in the previous 3 months. The last will be not older than 30 days
•7.Any CD4 cell count are admitted
•8.Patients can comply with the protocol requirements
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Previously demonstrated clinically allergy or hypersensitivity to any excipients of the investigational medications
•2. Ongoing treatment with immunomodulant drugs or growth factors (IL-2, G-CSF, GM-CSF)
•3.Treatments with steroids within 4 weeks before the enrolment
•4.Need to use pegIFN/RBV in the next two years
•5.Patients with Child Pugh > A 6
•6.Patients co-infected with HBV (HBsAg+)
•7.Patients with autoimmune diagnosed disorders
•8.Active drug abuse including alcohol or recreational drugs which, in the opinion of the investigator is expected to interfere with the patient?s ability to adhere to the study procedures and treatment regimen. Patients on a methadone program will be accepted if deemed appropriate by the investigator
•9.Patients with a grade 3/4 laboratory abnormality defined by DAIDS grading table
•10.Pregnant and breastfeeding women
•11.Any active clinically significant diseases or life threatening diseases or findings during screening of medical history or physical examination that in the investigator?s opinion, would compromise the patient?s safety and outcome of the study
•12.Use of disallowed concomitant therapy

发起方

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA