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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche |
Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00196586 |
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
Condition | Intervention | Phase |
HIV Infections Chronic Hepatitis C |
Drug: Interleukin 2 Drug: pegylated interferon alpha 2a Drug: ribavirin |
Phase II |
MedlinePlus related topics: | AIDS Hepatitis Hepatitis C |
ChemIDplus related topics: | Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin for the Treatment of Chronic Hepatitis C in HIV-HCV Coinfected Patients Non Responders to Three Months of Therapy With Pegylated Interferon Alpha 2a and Ribavirin. ANRS HC09 SECOIIA |
Estimated Enrollment: | 75 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | November 2006 |
This pilot study 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 Eligible patients should have CD4 cells count higher than 300/mm³ if pretreated by antiretroviral therapy or higher than 400/mm³ if naive of antiretroviral therapy, Metavir score with histological fibrosis score F1, F2 or F3.
Recombinant IL-2 will be given subcutaneously at a dose of 3 MUI twice daily for 5 days every 8 weeks for 5 cycles from week 14 to week 46. This national multicenter study will enroll around 75 patients in order to give IL-2 to 20 non-responders.
The primary endpoint is sustained virologic response, defined by undetectable serum HCV-RNA at week 72, six months after the end of therapy
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
Hopital Européen Georges Pompidou | |||||
Paris, France, 75015 |
French National Agency for Research on AIDS and Viral Hepatitis |
Hoffmann-La Roche |
Principal Investigator: | Laurence Weiss, MD | Hopital Européen Georges Pompidou Paris |
Study Director: | Jean-Pierre Aboulker, MD | Inserm SC10 |
Study ID Numbers: | ANRS HC09 SECOIIA |
First Received: | September 12, 2005 |
Last Updated: | November 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00196586 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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