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

Primary Purpose

Chronic Hepatitis C, HIV Infections

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
peg interferon plus ribavirin
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring peg interferon, ribavirin, HAART, HIV, Chronic Hepatitis C, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network, Toronto General Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To compare the sustained virological response.

Full Information

First Posted
February 23, 2006
Last Updated
April 19, 2007
Sponsor
University Health Network, Toronto
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00296972
Brief Title
Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
not funded
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, HIV Infections
Keywords
peg interferon, ribavirin, HAART, HIV, Chronic Hepatitis C, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
peg interferon plus ribavirin
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To compare the sustained virological response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Cooper, MD
Organizational Affiliation
The Ottawa Hospital, On
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marianne Harris, MD
Organizational Affiliation
St. Paul's Hospital, Vancouver B.C
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marina Klein, MD
Organizational Affiliation
Hopital Royal-Victoria/Institut Thoracique de Montreal,Que
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Poliquin, MD
Organizational Affiliation
Clinique Medicale L'Actuel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steve Shafran, MD
Organizational Affiliation
University of Alberta Hospital, AB
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anita Rachlis, MD
Organizational Affiliation
Sunnybrook & Women's College HSC, On
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chris Fraser, MD
Organizational Affiliation
Victoria, BC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Val Montessori, MD
Organizational Affiliation
St. Paul's Hospital, Vancouver B.C
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benoit Trottier, MD
Organizational Affiliation
Clinique Medicale L'Actuel, Que
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Farley, MD
Organizational Affiliation
Winnepeg, MB
Official's Role
Study Director
Facility Information:
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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