Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122616
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2005-07-19
Brief Title:
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and C Hepatitis Who Failed to Active Treatment for HCV ANRSHC12 Fibrostop
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus HCV when the treatment to eradicate the virus failed This scientific proof needs a comparative study to be done including two groups of patients randomly allocated one with the treatment peginterferon and the other without any treatment against HCV with a duration of 2 years To conclude two liver biopsies are needed one before the study and a second 2 years after
Detailed Description:
C hepatitis in HIV infected patient becomes a major issue although the survival of patients has improved in the last decades regarding to the advent of HAART the mortality related to liver disease has increased in this population Sustained virological response for HCV can be obtained with peg-interferon and ribavirin treatment but more or less 50 of patients experienced failure to this treatment and liver fibrosis due to HCV infection progress and may lead to cirrhosis and hepato-carcinoma To demonstrate the efficacy of peginterferon therapy to reduce the liver damage causes by HCV infection a randomised controlled study is needed comparing one group of patient treated by peginterferon and one group without any treatment against HCV infection In order to show 30 difference between the two groups in reducing one point of fibrosis score METAVIR scale 150 patients are needed The duration of the study is 96 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None