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

NCT ID: NCT00196586

Last Updated: 2007-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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

Conditions

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HIV Infections Chronic Hepatitis C

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interleukin 2

Intervention Type DRUG

pegylated interferon alpha 2a

Intervention Type DRUG

ribavirin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Laurence Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Européen Georges Pompidou Paris

Jean-Pierre Aboulker, MD

Role: STUDY_DIRECTOR

Inserm SC10

Locations

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Hopital Européen Georges Pompidou

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ANRS HC09 SECOIIA

Identifier Type: -

Identifier Source: org_study_id