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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

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ClinicalTrials.gov Identifier: NCT00296972
Recruitment Status : Terminated (not funded)
First Posted : February 27, 2006
Last Update Posted : April 23, 2007
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Health Network, Toronto

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis C HIV Infections Drug: peg interferon plus ribavirin Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Actual Study Completion Date : April 2007

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To compare the sustained virological response.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Hoffmann-La Roche
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00296972     History of Changes
Other Study ID Numbers: ML 18562A
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: April 23, 2007
Last Verified: April 2007

Keywords provided by University Health Network, Toronto:
peg interferon
ribavirin
HAART
 HIV
Chronic Hepatitis C
Treatment Experienced

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Interferons
Ribavirin
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action