Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132210
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2005-08-17
Brief Title:
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Status:
COMPLETED
Status Verified Date:
2009-11
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 purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals
Detailed Description:
BackgroundHIV-infected individuals are at higher risk of developing a chronic course of hepatitis C after infection Moreover chronic hepatitis C is less well treatable in HIV-Coinfected than in hepatitis C monoinfected patients There is basic research and clinical data on hepatitis C mono-infection supporting high sustained response rates of hepatitis C when treatment is started in the acute phase of infection
Aim of the study To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals
Methods Prospective open-label historical controlled trial Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4 Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection
Aim of the study To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals
Methods Prospective open-label historical controlled trial Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4 Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection
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