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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00196586 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients
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Scientific title:
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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 |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00196586 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Laurence Weiss, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Européen Georges Pompidou Paris |
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Name:
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Jean-Pierre Aboulker, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inserm SC10 |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C
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HIV Infections
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Intervention(s)
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Drug: pegylated interferon alpha 2a
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Drug: ribavirin
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Drug: Interleukin 2
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Secondary ID(s)
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ANRS HC09 SECOIIA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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