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

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

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

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

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
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Please refer to this study by its identifier: NCT00221650

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

Publications: 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
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action processed this record on May 30, 2016