Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | November 15, 2007 | ||||||||
| Start Date ICMJE | April 2003 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 | ||||||||
| Original Primary Outcome Measures ICMJE |
|
||||||||
| Change History | Complete list of historical versions of study NCT00196586 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 | ||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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 |
||||||||
| Detailed Description | 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 |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 75 | ||||||||
| Completion Date | November 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00196586 | ||||||||
| Other Study ID Numbers ICMJE | ANRS HC09 SECOIIA | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | French National Agency for Research on AIDS and Viral Hepatitis | ||||||||
| Collaborators ICMJE | Hoffmann-La Roche | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | French National Agency for Research on AIDS and Viral Hepatitis | ||||||||
| Verification Date | November 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||