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

Primary Purpose

HIV Infections, Chronic Hepatitis C

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Interleukin 2

pegylated interferon alpha 2a

ribavirin

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Chronic Hepatitis C, HIV infection, Interleukin-2, Pegylated interferon alpha 2 a, ribavirin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Européen Georges Pompidou

Outcomes

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

Full Information

NCT ID

NCT00196586

First Posted

September 12, 2005

Last Updated

November 15, 2007

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00196586

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Hoffmann-La Roche

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Chronic Hepatitis C

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

75 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Interleukin 2

Intervention Type

Drug

Intervention Name(s)

pegylated interferon alpha 2a

Intervention Type

Drug

Intervention Name(s)

ribavirin

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurence Weiss, MD

Organizational Affiliation

Hopital Européen Georges Pompidou Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean-Pierre Aboulker, MD

Organizational Affiliation

Inserm SC10

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Européen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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