Chronic hepatitis C in HIV/HCV coinfection MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Trade Name: LESCOL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fluvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV/HCV co-infection Hystologic confirmation of chronic hepatitis CD4 cell count > or equal to 350/mmc HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy or intolerance to the study medication pregnancy previous treatment with IFN or ribavirin End-stage liver disease Alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Number of subjects with positive HCV-RNA after 24 weeks of treatment. | — |
Countries
Italy
Outcome results
None listed