Evaluation of chronic hepatitis C treatment with PEG-IFN ALFA-2a and ribavirin in HIV-positive subjects with persistently normal transaminase levels. - Treatment of co-infected patients with normal ALT

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2007年10月16日最近更新: 2014年2月3日

适应症

试验速览

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•males and females, age 18-65 yrs, with baseline CD4+>/=300/mmc, compensated liver disease, hemato-chemical parameters suitable for PEG-IFN plus RBV therapy, normal glycaemia and thyroid function (or in good control if patient has specific alterations), negative auto-antibodies (or if present, at non significant title), normal alfa-fetoprotein level (or if elevated, less than 50 ng/ml and negative US for HCC), negative HBs Ag, adequate contraceptive measures to avoid pregnancy during therapy and for 6 months after the end of therapy, ability to subscribe informed consent.
•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

•pregnancy or breast feeding, previous treatment with IFN or PEG-IFN with or without RBV, HAART including AZT or ddI, ESLD, hemoglobinopathy, sever co-morbidities, previous or actual sever psychiatric diseases, auto-immune diseases, retinal diseases, not controlled diabetes, symptomatic gout, drug or alcohol abuse (>/= 80 g/day), inability to give informed consent.

发起方

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)