Chronic hepatitis C in illicit drug users and the role of antiviral therapy: the ARNICA project (Antiviral tReatment for chroNichepatItis C in Active substance users) - ARNICA

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 个研究点开始时间: 2008年4月9日最近更新: 2012年3月19日

试验速览

暂无简介。

•-age over 18 years;
•-HCVAb positivity (ELISA third generation test);
•-HCVRNA detected with a sensitive polimerase chain reaction (PCR) technique (cut-off<50UI/ml) at least in two recordings before screening;
•-HCV genotyping (InnoLipa);
•-compensated liver disease (Child-Pugh score <5, without any history of ascites, hepatic encefalopathy, bleeding from gastrointestinal tract);
•-willingness to avoid pregnancy during the whole study period and in the six months after last drug intake;
•-ability to read and sign a written informed consent to the study and willingness to adhere to the study.
•For patients with HIV/HCV coinfection following inclusion criteria are added:
•-HIVAb positivity (ELISA test and Western blot confirmation test for anti HIV-1 antibody);
•-CD4+ lymphocyte count over 200/mm3 in the last six months;
•-stability of the HIV infection in physician opinion.
•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

•-Ipersensibility to interferon or ribavirin
•-pregnancy or breast feeding
•-Clinical history of cardiac failure, severe psichiatric disease, seizure, tyroid not compensated disease, any other severe chronic disease in sperimentator's opinion
•-Autoimmune hepatitis
•-decompenstaed liver failure
•-Hb<11g/dL in women and <12g/dL in men
•-Neutrophil count<1500/mmc
•-platelet count <90000/mmc
•-creatinine level<1.5 upper limit of normal range
•-Severe retinopathy
•For HIVAb+ patients:
•-opportunistic infection or neoplastic malignancy
•-concomitant antiretroviral theraoy with AZt or d4T or ddI

发起方

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA