Status:
TERMINATED
Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Chronic Hepatitis C
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 continu...
Detailed Description
Since the introduction of highly active antiretroviral therapies (HAART), liver disease secondary to HCV infection has become a leading cause of morbidity and mortality in HIV/HCV co-infection. The in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00296972
Start Date
July 1 2005
End Date
April 1 2007
Last Update
April 23 2007
Active Locations (1)
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1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2