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

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

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.


Estimated Enrollment:	100
Study Start Date:	July 2005
Study Completion Date:	April 2007

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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:


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

ClinicalTrials.gov processed this record on September 26, 2016