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Completed

NCT Number: NCT00196586

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Chronic Disease Chronic Hepatitis C Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Européen Georges Pompidou

Paris, 75015, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interleukin 2

Drug

pegylated interferon alpha 2a

Drug

Ribavirin

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Nov 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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