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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
September 13, 2005
June 12, 2007
April 2002
Not Provided
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 ]
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment
Complete list of historical versions of study NCT00221650 on ClinicalTrials.gov Archive Site
  • 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
  • - Proportion of patients with a virological response 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
Not Provided
Not Provided
 
Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C, Chronic
  • Treatment Failure
  • Drug: Peginterferon alfa2a
  • Drug: Ribavirin
Not Provided
Thiébaut R, Guedj J, Jacqmin-Gadda H, Chêne G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
June 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00221650
9232-01
2000-023
Yes
Not Provided
Not Provided
Not Provided
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
University Hospital, Bordeaux
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP