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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00076427 |
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.
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Condition |
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Hepatitis C HIV Infections |
Study Type: | Observational |
Official Title: | Evaluation of Clinical, Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications |
Estimated Enrollment: | 150 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
HCV infection is known to cause morbidity and mortality especially among those who are coinfected with HIV. The underlying immunopathogenesis of persistence of HCV 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 would definitely be important in development of a vaccine for HCV. 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. This study will recruit individuals who are coinfected with both HIV and HCV as well as those who are monoinfected with HCV. The study will require that patients be apheresed several times after enrollment. Apheresis will be necessary 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, and characterizing natural killer function relative to HCV disease and identify biomarkers for prgression of liver disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. All patients will receive a liver biopsy (every 3 years for co-infected and every 5 years for mono-infected) subjects to assess the progression of liver disease performed at the NIH.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA - For Mono-infected Patient:
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 040086, 04-I-0086 |
Study First Received: | January 21, 2004 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00076427 History of Changes |
Health Authority: | United States: Federal Government |
Immunity Liver Apheresis Cytokine |
Virology Hepatitis C HCV Hepatitis C co-infection |
Sexually Transmitted Diseases, Viral Liver Diseases Immunologic Factors Hepatitis, Chronic Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis |
Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis C Hepatitis C, Chronic Retroviridae Infections |
Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Immune System Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection |
Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Hepatitis C Retroviridae Infections |