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

NCT ID: NCT00296972

Last Updated: 2007-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-04-30

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 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.

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 influence of HCV co-infection on the progression of HIV has been less clear and the results have been conflicting. Studies conducted in the pre-HAART era did not find that HIV/HCV co-infection influenced the progression of HIV-induced immunodeficiency or death. Of four large studies conducted after HAART was introduced, two suggested a faster progression of HIV disease in the presence of HCV co-infection and two found no influence of HCV co-infection on overall mortality or progression of HIV disease. HCV may also negatively influence HIV disease in indirect ways, such as making the discontinuation of antiretroviral treatment more frequent because of an increased risk of liver toxicity.The morbidity and mortality resulting from the rapid progression of HCV infection in HIV-co-infected patients, particularly given the advances in HIV treatment that have improved the life expectancy of HIV-infected patients, support treating HCV infection in these patients.

Conditions

Chronic Hepatitis C; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

peg interferon plus ribavirin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Curtis Cooper, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital, On

Marianne Harris, MD

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver B.C

Marina Klein, MD

Role: STUDY_DIRECTOR

Hopital Royal-Victoria/Institut Thoracique de Montreal,Que

Mark Poliquin, MD

Role: STUDY_DIRECTOR

Clinique Médicale L'Actuel

Steve Shafran, MD

Role: STUDY_DIRECTOR

University of Alberta Hospital, AB

Anita Rachlis, MD

Role: STUDY_DIRECTOR

Sunnybrook & Women's College HSC, On

Chris Fraser, MD

Role: STUDY_DIRECTOR

Victoria, BC

Val Montessori, MD

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver B.C

Benoit Trottier, MD

Role: STUDY_DIRECTOR

Clinique Medicale L'Actuel, Que

John Farley, MD

Role: STUDY_DIRECTOR

Winnepeg, MB

Locations

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

ML 18562A

Identifier Type: -

Identifier Source: org_study_id