Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication
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.
Chronic Hepatitis C
Drug: peg interferon plus ribavirin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter, phaseIIIB, Two Arm Study Evaluating the Tolerability of Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection co-Infected With Human Immunodeficiency Virus Receiving HAART Versus Not Receiving HAART|
- To compare the safety and tolerability of PEG-IFN with ribavirin in HIV/HCV co-infected patients who continue HAART therapy compared to those who discontinue HAART therapy in the first 12 weeks
- To compare the sustained virological response.
|Study Start Date:||July 2005|
|Study Completion Date:||April 2007|
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.
|University Health Network, Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2N2|
|Study Director:||Curtis Cooper, MD||The Ottawa Hospital, On|
|Study Director:||Marianne Harris, MD||St. Paul's Hospital, Vancouver B.C|
|Study Director:||Marina Klein, MD||Hopital Royal-Victoria/Institut Thoracique de Montreal,Que|
|Study Director:||Mark Poliquin, MD||Clinique Medicale L'Actuel|
|Study Director:||Steve Shafran, MD||University of Alberta Hospital, AB|
|Study Director:||Anita Rachlis, MD||Sunnybrook & Women's College HSC, On|
|Study Director:||Chris Fraser, MD||Victoria, BC|
|Study Director:||Val Montessori, MD||St. Paul's Hospital, Vancouver B.C|
|Study Director:||Benoit Trottier, MD||Clinique Medicale L'Actuel, Que|
|Study Director:||John Farley, MD||Winnepeg, MB|