Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00296972|
Recruitment Status : Terminated (not funded)
First Posted : February 27, 2006
Last Update Posted : April 23, 2007
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 or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C HIV Infections||Drug: peg interferon plus ribavirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2005|
|Study Completion Date :||April 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296972
|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|