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

NCT00196586 | Completed Phase 2

• 1 other identifier: ANRS HC09 SECOIIA
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections; Chronic Hepatitis C

Keywords

Chronic Hepatitis C; HIV infection; Interleukin-2; Pegylated interferon alpha 2 a; ribavirin

Outcome Measures

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

Interventions

Interleukin 2 DRUG

pegylated interferon alpha 2a DRUG

ribavirin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cirrhosis (histological fibrosis score F4 in Metavir score)
• Other liver disease
• Pregnancy

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Hopital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C, Chronic

Interventions

Interleukin-2; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Laurence Weiss, MD

  Hopital Européen Georges Pompidou Paris

  PRINCIPAL INVESTIGATOR

• Jean-Pierre Aboulker, MD

  Inserm SC10

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2003
• Study Completion: November 1, 2006
• Last Updated: November 16, 2007

Record last verified: 2007-11

Locations

FR (1)