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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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HIV Infections, Chronic Hepatitis C

Intervention / Treatment
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* Drug: Interleukin 2
* Drug: pegylated interferon alpha 2a
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interleukin 2|nan|
|Drug: pegylated interferon alpha 2a|nan|
|Drug: ribavirin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response, defined by undetectable serum HCV-RNA at week 72, six months after the end of treatment; Safety of IL-2 in combination with pegylated interferon and ribavirin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response at the end of treatment at week 48, Biochemical response, CD4 cell counts and HIV-RNA plasma levels from baseline to week 72 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, HIV infection, Interleukin-2, Pegylated interferon alpha 2 a, ribavirin