Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055341
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2003-02-25
Brief Title:
Treatment of Hepatitis C in Hemophilic Patients With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Multicenter Phase II Open Label Controlled Trial Evaluating the Response of Hepatitis C Virus HCV to Pegylated Interferon Alpha-2A and Ribavirin in Hemophilic Patients With and Without Coinfection With the Human Immunodeficiency Virus HIV
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Pegylated interferon PEG-interferon and ribavirin are accepted treatments for hepatitis C virus HCV infection However HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs
Detailed Description:
Hemophiliacs with symptomatic disease often receive blood products to correct clotting factor deficiencies Prior to routine use of heat inactivation and screening of donor blood for specific viral pathogens hemophiliacs were routinely exposed to and infected with viruses such as hepatitis B HBV HCV and HIV Studies in hemophiliacs suggest several important findings that warrant further investigation including 1 hemophiliacs infected with HCV may have more rapid progression to liver failure and death 2 pooled blood concentrate from multiple donors leads to a high risk of mixed infection and 3 different clinical outcomes and altered immune responses of HIV coinfected hemophiliacs may enhance understanding of mutant virus selection and the associated clinical outcomes The purpose of this trial is to determine response rates to PEG-interferon and ribavirin in hemophiliacs with HCV alone and with HCVHIV coinfection
Participants in this study will be followed for 48 weeks on treatment and up to 36 months after treatment Participants in this study will be admitted to the Clinical Research Center for 2 days at the beginning of the study Participants will have 3 additional study visits in the first week of the study After that study visits occur at Weeks 2 4 8 12 16 24 32 40 and 48 The follow-up visits will be at 4 12 and 24 weeks following the end of treatment Study visits include a physical exam and blood tests Patients who do not respond to treatment will be followed in a prospective cohort study for up to 3 additional years so that evolution of the virus and associated immune responses can be evaluated
Participants in this study will be followed for 48 weeks on treatment and up to 36 months after treatment Participants in this study will be admitted to the Clinical Research Center for 2 days at the beginning of the study Participants will have 3 additional study visits in the first week of the study After that study visits occur at Weeks 2 4 8 12 16 24 32 40 and 48 The follow-up visits will be at 4 12 and 24 weeks following the end of treatment Study visits include a physical exam and blood tests Patients who do not respond to treatment will be followed in a prospective cohort study for up to 3 additional years so that evolution of the virus and associated immune responses can be evaluated
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AI049508-02 | NIH | None | httpsreporternihgovquickSearch5R01AI049508-02 |