Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to evaluate efficacy and safety of addition of IL-2 to pegylated interferon alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders after three months of standard therapy with pegylated interferon alpha 2a and ribavirin. IL-2 may enhance numbers and function of CD4 T lymphocytes and specific anti-HCV immune responses and could participate to the control of HCV replication

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Hoffmann-La Roche
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Interleukin-2; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• HIV-1 infection and HCV infection

• Naive of ribavirin

• CD4 higher than 300 if pretreated by antiretroviral therapy or higher than 400 if naive of antiretroviral therapy

• Signed informed consent

Exclusion Criteria:

• Cirrhosis (histological fibrosis score F4 in Metavir score)

• Other liver disease

• Pregnancy