Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to compare the safety, effectiveness and tolerability of using Pegasys with Copegus in people who have both the hepatitis C virus (HCV) genotype 1 and HIV who continue taking HAART (highly active antiretroviral therapy) to those who discontinue taking HAART.

Canadian guidelines recommend that both HIV and HCV should not be treated at the same time as the medications needed to treat these two diseases may interact and that which disease to treat first is dependent on the CD4 count. In this study, the CD4 count must be over 350 cells and one must be stable on HAART before starting the study medication Pegasys in combination with Copegus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Hoffmann-La Roche
• Treatments: Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Hepatitis C genotype 1 infection·

• Detectable plasma HCV-RNA Roche>1000copies/ml, >600IU/ml

• Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 24 months

• Patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomization

• Patients with CD4 cell count ³ 350 cells /µL

• Patients on stable highly active antiretroviral therapy (HAART) for at least 12 weeks prior to baseline with the exception of patients receiving didanosine

• HIV-1 RNA is < 5000 copies/mL

Exclusion Criteria:

• IFN, pegylated interferons, viramidine, levovirin, or ribavirin therapy at any previous time

• Patients with evidence of active hepatitis B infection. ( presence of HbsAg)

• History or evidence of decompensated liver disease and/or a Child-Pugh score > 5, bleeding from esophageal varices, hepatic malignancy

• abnormal bloodwork ie absolute neutrophil <1,Hbg <110, Platelets <70,creatinine <50