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 |
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Recruitment Status :
Terminated
(not funded)
First Posted : February 27, 2006
Last Update Posted : April 23, 2007
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Sponsor:
University Health Network, Toronto
Collaborator:
Hoffmann-La Roche
Information provided by:
University Health Network, Toronto
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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 |
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 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 |
Resource links provided by the National Library of Medicine
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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 |
| 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:
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peg interferon ribavirin HAART |
HIV Chronic Hepatitis C Treatment Experienced |
Additional relevant MeSH terms:
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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 |