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

HIV Infections Clinical Trial

— ROCO2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221650
• Other study ID #: 9232-01
• Secondary ID: 2000-023
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 12, 2007
• Start date: April 2002
• Est. completion date: June 2004

Study information

• Verified date: June 2007
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Treatment Failure

Intervention

Drug:
• Peginterferon alfa2a

• Ribavirin

Locations

Country	Name	City	State
France	Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Hoffmann-La Roche, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level		24 weeks after the end of anti-HCV treatment
Secondary	Proportion of patients with a virological response		at weeks 24 and 48
Secondary	Safety of treatment
Secondary	Influence of anti-HCV treatment on CD4 count and HIV RNA
Secondary	Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment