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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche |
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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 |
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HIV Infections Chronic Hepatitis C |
Drug: Interleukin 2 Drug: pegylated interferon alpha 2a Drug: ribavirin |
Phase II |
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 |
Principal Investigator: | Laurence Weiss, MD | Hopital Européen Georges Pompidou Paris |
Study Director: | Jean-Pierre Aboulker, MD | Inserm SC10 |
Study ID Numbers: | ANRS HC09 SECOIIA |
Study First Received: | September 12, 2005 |
Last Updated: | November 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00196586 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Chronic Hepatitis C HIV infection Interleukin-2 Pegylated interferon alpha 2 a ribavirin |
Antimetabolites Anti-Infective Agents Liver Diseases Sexually Transmitted Diseases, Viral Interferon Type I, Recombinant Hepatitis, Chronic Immunologic Factors Ribavirin Hepatitis, Viral, Human Analgesics Hepatitis C Retroviridae Infections Interferon-alpha Acquired Immunodeficiency Syndrome Interferons |
Antiviral Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Virus Diseases Hepatitis Digestive System Diseases Analgesics, Non-Narcotic HIV Infections Interleukin-2 Sexually Transmitted Diseases Peginterferon alfa-2a Peripheral Nervous System Agents Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Liver Diseases Interferon Type I, Recombinant Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Hepatitis, Chronic Flaviviridae Infections Antineoplastic Agents Physiological Effects of Drugs Ribavirin Hepatitis, Viral, Human Infection |
Sensory System Agents Therapeutic Uses Analgesics Growth Inhibitors Angiogenesis Modulating Agents Hepatitis C Retroviridae Infections Interferon-alpha RNA Virus Infections Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Interferons Angiogenesis Inhibitors Antiviral Agents |