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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00221650
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 13, 2007
Hoffmann-La Roche
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Hepatitis C, Chronic Treatment Failure Drug: Peginterferon alfa2a Drug: Ribavirin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2002
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Proportion of patients with a virological response [ Time Frame: at weeks 24 and 48 ]
  2. Safety of treatment
  3. Influence of anti-HCV treatment on CD4 count and HIV RNA
  4. Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00221650     History of Changes
Other Study ID Numbers: 9232-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007

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