Clinical trial NCT00196586: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Chronic Hepatitis C
Keywords: Chronic Hepatitis C
HIV infection
Interleukin-2
Pegylated interferon alpha 2 a
ribavirin
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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:
measure: 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
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
Study officials:
affiliation: Hopital Européen Georges Pompidou Paris
name: Laurence Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm SC10
name: Jean-Pierre Aboulker, MD
role: STUDY_DIRECTOR
References: