A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and Efficacy of Pegasys 180 µg plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 µg plus Copegus 800 mg in Interferon-naïve Patients with Chronic Hepatitis C Genotype 1 virus infection coinfected with human immunodeficiency virus (HIV-1).

F. Hoffmann-La Roche Ltd0 sites400 target enrollmentApril 24, 2006

ConditionsPatients with chronic hepatitis C (CHC) genotype 1 virus coinfected with human immunodeficiency virus type 1 (HIV-1)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with chronic hepatitis C (CHC) genotype 1 virus coinfected with human immunodeficiency virus type 1 (HIV-1)
Sponsor: F. Hoffmann-La Roche Ltd
Enrollment: 400
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 24, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche Ltd

Eligibility Criteria

Inclusion Criteria

•Male and female patients \>\= 18 years of age
•Serological evidence of CHC infection by an anti\-HCV antibody test (current or historical)
•Detectable plasma HCV\-RNA (\>600 IU/mL)
•Evidence of HCV genotype 1 infection by molecular assay
•Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 18 months as judged by a central pathologist. Up to 20% of patients with cirrhosis or incomplete cirrhosis will be allowed to enter the trial
•Child Pugh total score at screening must be equal to 5 for a patient with cirrhosis or bridging fibrosis/transition to cirrhosis to be enrolled into NV18209\. The only exception would be an elevation in Child Pugh total score (of \>\= 6\) secondary to total bilirubin as a consequence of a concomitant medication (e.g. atazanavir and indinavir) or a clinical condition (e.g. Gilbert's syndrome) that may cause hyperbilirubinemia. An elevation in Child Pugh total score (of \>\= 6\) secondary to albumin, INR, ascites or hepatic encephalopathy will not be acceptable
•Patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma (within 2 months of randomization) and a serum alpha\-fetoprotein (AFP) \<100 ng/mL
•Serological evidence of HIV\-1 infection by HIV\-1 antibody or detection of HIV\-1 RNA
•Clinically stable status of HIV\-1 infection in the opinion of the investigator, ie, patients who are not expected to progress during the study
•Patients with a CD4\+ count \>\= 100 cells/µL

Exclusion Criteria

•History of having received alpha IFNs, PEG\-IFN, ribavirin (RBV), viramidine, levovirin or investigational HCV protease or polymerase inhibitors at any previous time. Any history of systemic antiviral therapy, with established or perceived activity against HCV, \=\< 3 months prior to the first dose of study medication
•Infection with any HCV genotype other than genotype 1 or infection with a mixed genotype or with a genotype that can not be established as genotype 1, i.e. ndeterminant genotype
•History or other evidence of decompensated liver disease or a Child\-Pugh score \>5\.
•Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or other conditions consistent with decompensated liver disease
•Positive test result at screening for anti\-HAV IgM Ab, HBsAg, anti\-HBc IgM Ab
•History or other evidence of a medical condition associated with chronic liver disease other than HCV
•Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is \>\= 20% within 2 years. Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening imaging study will be eligible only if the likelihood of carcinoma is \=\<10% following an appropriate evaluation
•Active HIV\-related opportunistic infection and/or malignancy requiring acute systemic therapy
•Within 6 weeks of starting the study screening period, the use of colony stimulating factors , such as granulocyte colony stimulating factor (GCSF) or erythropoietin to elevate hematology parameters. (These factors may be used after treatment has commenced)
•Absolute neutrophil count (ANC) \<1500 cells/mm3, except for African\-Americans whose ANC should not be \<1200 cells/mm3