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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C, Chronic
  • Treatment Failure
  • Drug: Peginterferon alfa2a
  • Drug: Ribavirin
Not Provided
Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221650
9232-01, 2000-023
Yes
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