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Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients (ROCO2)

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221650
First received: September 13, 2005
Last updated: June 12, 2007
Last verified: June 2007
History of Changes
  Purpose

Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.


Condition Intervention Phase
HIV Infections
Hepatitis C, Chronic
Treatment Failure
 Drug: Peginterferon alfa2a
Drug: Ribavirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level [ Time Frame: 24 weeks after the end of anti-HCV treatment ]

Secondary Outcome Measures:
  • Proportion of patients with a virological response [ Time Frame: at weeks 24 and 48 ]
  • Safety of treatment
  • Influence of anti-HCV treatment on CD4 count and HIV RNA
  • Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

Enrollment: 17
Study Start Date: April 2002
Study Completion Date: June 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level
  • HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy
  • Signed informed consent

Exclusion Criteria:

  • Chronic hepatitis B
  • Alcohol consumption>40g/day
  • Evidence of decompensated liver disease
  • Hepatocellular carcinoma
  • Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221650

Locations
France
Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Hoffmann-La Roche
Ministry of Health, France
Investigators
Principal Investigator: Didier Neau, MD-PhD Hôpital Pellegrin, 33076 Bordeaux Cedex, France
Study Chair: Genevieve Chene, Pr University Hospital, Bordeaux
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00221650     History of Changes
Other Study ID Numbers: 9232-01, 2000-023
Study First Received: September 13, 2005
Last Updated: June 12, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Hepatitis C, Chronic
HCV infection
HIV infection
Treatment Failure
PEG interferon
Interferons/therapeutic use
 Interferon Alfa-2a/adverse effects
Ribavirin/therapeutic use
Ribavirin/adverse effects
Drug Therapy, Combination
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013