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Sponsors and Collaborators: |
University Health Network, Toronto Hoffmann-La Roche |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00296972 |
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.
Condition | Intervention | Phase |
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Chronic Hepatitis C HIV Infections |
Drug: peg interferon plus ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
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 |
Study ID Numbers: | ML 18562A |
Study First Received: | February 23, 2006 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00296972 |
Health Authority: | Canada: Health Canada |
peg interferon ribavirin HAART |
HIV Chronic Hepatitis C Treatment Experienced |
Sexually Transmitted Diseases, Viral Liver Diseases Hepatitis, Chronic Interferons Ribavirin Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis |
Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic Retroviridae Infections |
Antimetabolites Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Flaviviridae Infections Antineoplastic Agents Infection Antiviral Agents Pharmacologic Actions Therapeutic Uses Lentivirus Infections |