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: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-
Pharmaceutical Form: Ca
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1)Non Response (NR): positive HCV-RNA PCR after 6 months of therapy and discontinuation. 2)Early Virological Response (EVR): 2 logs drop of HCV-RNA compared to baseline level or negative PCR at 12 weeks of therapy. 3)End of Treatment Response (ETR): negative HCV-RNA PCR at the end of therapy. 4)Relapse: re-appearance of HCV-RNA after the end of therapy. 5)Sustained Virological Response (SVR): negative HCV-RNA PCR 24 weeks after the end of therapy. | — |
Countries
Italy
Outcome results
None listed