Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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
- 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
| 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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00196586 History of Changes |
| Other Study ID Numbers: | ANRS HC09 SECOIIA |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 15, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
Chronic Hepatitis C HIV infection Interleukin-2 Pegylated interferon alpha 2 a ribavirin |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferons Ribavirin Peginterferon alfa-2a Interleukin-2 Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on October 16, 2012
