¨Hepatitis C Crónica
Conditions
Interventions
Trade Name: Pegasys 180 microgrames
Product Name: peginterferon alfa 2a
Product Code: peginterferon alfa 2a
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: peginterferon alfa-2a
Con
Sponsors
Hospital Universitario de Valme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >18 years CD4+ levels between 50-250 mm3 during at least 48 weeks before the beginning of the study Indetectable VC during 48 weeks before the beginning the study Pregnancy test negative in urine during 24 h. before the first dose Acceptance of written informed consent - BEFORE TREATMENT Chronic hepatitis serologic evidence with anti-HCV antibodies test Chronic hepatopathy consisting in a biopsy HIV-1 serologic evidence 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: Virologic failure or clinic events of AIDS 48 weeks before treatment Pregnant or in lactation women/couples Decompensated cirrhosis patients Treated with any experimental pharmaco Treated with D4T/DDI Positive test for immunoglobulines Other hepatic diseases associated Blood alterations-analitical alterations Evidence of hepatocarcinome or conditions of decompensated hepatic disease Severe psichiatric disease, immunologic disease history, chronic disease with functional limitation, significative cardiac disease history, thyroide related history, neoplasy (with treatment or sistemic immunomodulator) Concomitant medication with rifampicine, pirazinamide, isoniazide Drug use or excesive alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate security of treatment with peginterferon alfa 2a in combination with ribavirin in VIH patients coinfected with hepatitis C with CD4 low levels ;Secondary Objective: To evaluate the efficacy of treatment with peginterferon alfa 2a in combination with ribavirin in VIH patients coinfected with hepatitis C with CD4 low levels;Primary end point(s): Security: 1: percentage of patients with treatment interruption with peginterferon alfa 2a and ribavirin during the study 2: AIDS diagnosed clinic events CD4+ cells levels during the study Adverse events in general Hepatic decompensation and deaths Requiring preventive treatment for oportunist processes during treatment EFICACY Percentage of patients with VSR with peginterferon alfa 2a and ribavirin | — |
Countries
Spain
Outcome results
None listed