Fluvastatin as adjuvant therapy to alfa-interferon and ribavirin in the treatment of chronic hepatitis C in patients with HIV-1 coinfection - ND

• Conditions: Chronic hepatitis C in HIV/HCV coinfection; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2006-006588-21-IT
• Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

HIV/HCV co-infection

Hystologic confirmation of chronic hepatitis

CD4 cell count > or equal to 350/mmc

HIV-RNA < 20,000 cp/mL

Absence of autoantibodies
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergy or intolerance to the study medication

pregnancy

previous treatment with IFN or ribavirin

End-stage liver disease

Alcohol abuse

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 safety and antiviral efficacy of fluvastatin as adjuvant to IFN and ribavirin in the treatment of patients with chronic hepatitis C and HIV infection.;Secondary Objective: Evaluation of the modification of immunologic and lipid metabolic parameters.;Primary end point(s): Number of subjects with end treatment virologic response and sustained virologic response.<br><br>Number of subjects with positive HCV-RNA after 24 weeks of treatment.