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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 12, 2007

Start Date ^ICMJE

April 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment

Change History

Complete list of historical versions of study NCT00221650 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- 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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections
Hepatitis C, Chronic
Treatment Failure

Intervention ^ICMJE

Drug: Peginterferon alfa2a
Drug: Ribavirin

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00221650

Other Study ID Numbers ^ICMJE

9232-01, 2000-023

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Bordeaux

Collaborators ^ICMJE

Hoffmann-La Roche
Ministry of Health, France

Investigators ^ICMJE

Principal Investigator:	Didier Neau, MD-PhD	Hôpital Pellegrin, 33076 Bordeaux Cedex, France
Study Chair:	Genevieve Chene, Pr	University Hospital, Bordeaux

Information Provided By

University Hospital, Bordeaux

Verification Date

June 2007

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

To Top