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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Purpose
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 |
|---|---|---|
|
Chronic Hepatitis C HIV Infections |
Drug: peg interferon plus ribavirin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- 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.
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00296972 History of Changes |
| Other Study ID Numbers: | ML 18562A |
| Study First Received: | February 23, 2006 |
| Last Updated: | April 19, 2007 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
peg interferon ribavirin HAART |
HIV Chronic Hepatitis C Treatment Experienced |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferons Ribavirin Peginterferon alfa-2a Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on March 03, 2013
