Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076427
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2004-01-21
Brief Title:
Leukapheresis for Research on HCV-Coinfected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Clinical Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications
Status:
COMPLETED
Status Verified Date:
2015-06-09
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:
This study will collect quantities of white blood cells from patients infected with the hepatitis C virus HCV for research on the interactions between HCV and the human immunodeficiency virus HIV in people infected with both of these agents Several studies have shown that infection with HIV adversely affects liver disease due to HCV
Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone may be eligible for this study Candidates must not have liver failure and must not be undergoing treatment for HCV at the time of enrollment
Participants will undergo leukapheresis to collect white blood cells This procedure allows collection of larger numbers of cells than would be possible with simple blood drawing For the procedure blood is removed through a needle in the vein of one arm and spun in a machine that separates the blood into its components The white cells are extracted and the rest of the blood is re-infused through the same needle or through a needle in the other arm The procedure takes approximately 1-3 hours depending on the amount of white cells being collected A maximum of three leukapheresis procedures are done If additional procedures are required the patient will sign a new consent form Procedures will be limited to no more than three times a year or once every 4 months
Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone may be eligible for this study Candidates must not have liver failure and must not be undergoing treatment for HCV at the time of enrollment
Participants will undergo leukapheresis to collect white blood cells This procedure allows collection of larger numbers of cells than would be possible with simple blood drawing For the procedure blood is removed through a needle in the vein of one arm and spun in a machine that separates the blood into its components The white cells are extracted and the rest of the blood is re-infused through the same needle or through a needle in the other arm The procedure takes approximately 1-3 hours depending on the amount of white cells being collected A maximum of three leukapheresis procedures are done If additional procedures are required the patient will sign a new consent form Procedures will be limited to no more than three times a year or once every 4 months
Detailed Description:
Hepatitis C virus HCV and Hepatitis B HBV infection are known to cause morbidity and mortality especially among those who are coinfected with Human Immunodeficiency virus HIV HCV infected individuals who are also coinfected with HIV have more rapid progression of liver disease abnormal diagnostic serologies higher levels of HCV viremia and markedly lower levels of therapeutic responses to the standard combination therapy with peginterferon and ribavirin
The underlying immunopathogenesis of HCV and HBV infection progression of liver disease and interactions with HIV are not yet clearly understood A clear understanding of the immune correlates of protection against HCV and HBV are important in development of a vaccine for HCV and novel immune-based therapeutics for the cure of HBV
This study will recruit individuals who are coinfected with HIV and HCV andor HBV as well as those who are monoinfected with HCV or HBV The study will enroll 2 groups Participants in the first group hereafter referred to as Group 1 will consist of participants recruited for research and clinical related blood draws leukapheresis and liver biopsies for long term study participation Participants in the second group hereafter referred to as Group 2 will consist of participants with known or suspected HCV andor HBV who need assistance with diagnosis or treatment
Participants in Group 1 will be apheresed or undergo blood draw several times after enrollment and may be followed for up to 10 years Participants in Group 2 will be evaluated for HBV andor HCV infection or complications or receive treatment The expectation is that may be followed for one year
Leukapheresis is used in Group 1 in order to obtain sufficient cells to pursue the following objectives delineating B cell response to CD4 T cell help delineating CD8 T factors associated with suppression of viral replication and normalization of immune function characterizing natural killer function relative to HCV andor HBV disease and identifying biomarkers for progression of liver disease The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using leukapheresis procedures in the Clinical Center Apheresis Unit Participants who do not meet apheresis criteria may participate through routine blood draws to contribute to this research All participants in Group 1 may also receive a liver biopsy at NIH every 3 years for HIVHCV coinfected and all HBV infected and every 5 years for HCV monoinfected subjects to assess the progression of liver disease
Treatment plans for Group 2 HBV andor HCV will be in accordance with standard medical practice and the number and length of additional visits and diagnostic evaluations will vary accordingly
The underlying immunopathogenesis of HCV and HBV infection progression of liver disease and interactions with HIV are not yet clearly understood A clear understanding of the immune correlates of protection against HCV and HBV are important in development of a vaccine for HCV and novel immune-based therapeutics for the cure of HBV
This study will recruit individuals who are coinfected with HIV and HCV andor HBV as well as those who are monoinfected with HCV or HBV The study will enroll 2 groups Participants in the first group hereafter referred to as Group 1 will consist of participants recruited for research and clinical related blood draws leukapheresis and liver biopsies for long term study participation Participants in the second group hereafter referred to as Group 2 will consist of participants with known or suspected HCV andor HBV who need assistance with diagnosis or treatment
Participants in Group 1 will be apheresed or undergo blood draw several times after enrollment and may be followed for up to 10 years Participants in Group 2 will be evaluated for HBV andor HCV infection or complications or receive treatment The expectation is that may be followed for one year
Leukapheresis is used in Group 1 in order to obtain sufficient cells to pursue the following objectives delineating B cell response to CD4 T cell help delineating CD8 T factors associated with suppression of viral replication and normalization of immune function characterizing natural killer function relative to HCV andor HBV disease and identifying biomarkers for progression of liver disease The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using leukapheresis procedures in the Clinical Center Apheresis Unit Participants who do not meet apheresis criteria may participate through routine blood draws to contribute to this research All participants in Group 1 may also receive a liver biopsy at NIH every 3 years for HIVHCV coinfected and all HBV infected and every 5 years for HCV monoinfected subjects to assess the progression of liver disease
Treatment plans for Group 2 HBV andor HCV will be in accordance with standard medical practice and the number and length of additional visits and diagnostic evaluations will vary accordingly
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 |
|---|---|---|---|
| 04-I-0086 | None | None | None |