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

• Conditions: Treatment of adult patients with hystologically demonstrated chronic C hepatitis without hepatic failure and HCV-RNA positive, treatment of patients with normal ALT and with HIV/HCV co-infection.; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2007-005698-76-IT
• Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy, tolerability and feasibility of combination therapy with PEG-IFN alfa-2a and RBV in HIV/HCV subjects with persistently normal ALT levels.;Secondary Objective: Determine the prevalence of this condition in an Italian cohort of HIV/HCV subjects and assess the possible impact of anti-HCV therapy on hepatic fibrosis and tolerability of antiretroviral therapy.;Primary end point(s): Efficacy will be evaluated as follows: <br><br>1)Non Response (NR): positive HCV-RNA PCR after 6 months of therapy and discontinuation.<br><br>2)Early Virological Response (EVR): 2 logs drop of HCV-RNA compared to baseline level or negative PCR at 12 weeks of therapy.<br><br>3)End of Treatment Response (ETR): negative HCV-RNA PCR at the end of therapy.<br><br>4)Relapse: re-appearance of HCV-RNA after the end of therapy.<br><br>5)Sustained Virological Response (SVR): negative HCV-RNA PCR 24 weeks after the end of therapy.