EUCTR2007-005698-76-IT
Active, not recruiting
Not Applicable
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 sitesOctober 16, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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