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

NCT00296972 | Terminated Phase 3

• 1 other identifier: ML 18562A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C; HIV Infections

Keywords

peg interferon; ribavirin; HAART; HIV; Chronic Hepatitis C; Treatment Experienced

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• To compare the sustained virological response.

Interventions

peg interferon plus ribavirin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; HIV Infections

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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 Médicale 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: July 1, 2005
• Study Completion: April 1, 2007
• Last Updated: April 23, 2007

Record last verified: 2007-04

Locations

CA (1)