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

This study has been completed.

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
  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 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   

U.S. FDA Resources

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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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:
  • 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

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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196586

Locations
France
Hopital Européen Georges Pompidou    
      Paris, France, 75015

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche

Investigators
Principal Investigator:     Laurence Weiss, MD     Hopital Européen Georges Pompidou Paris    
Study Director:     Jean-Pierre Aboulker, MD     Inserm SC10    
  More Information


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

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  

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Sexually Transmitted Diseases, Viral
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Lentivirus Infections
Peripheral Nervous System Agents
Analgesics
Growth Inhibitors
Angiogenesis Modulating Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2008




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