Protocol Number: 00-DK-0125

Title:

Immunogenetics of Hepatitis C Virus Infection

Number:

00-DK-0125

Summary:

The diverse clinical syndromes associated with hepatitis C underscore the multifactorial and polygenic nature of HCV infection. Both viral and host factors likely contribute to variations in infection outcome, disease susceptibility and progression, and treatment response. This protocol will focus on the immunogenetics of HCV infection. Various candidate genes, most of them related to host immune response in microbial infection, have defined genetic polymorphisms that have been associated with variable manifestations of infections including malaria, tuberculosis, leprosy, AIDS and hepatitis B. In this proposal, we plan to collect peripheral blood mononuclear cells as a source of DNA from approximately 1500 patients with HCV infection, analyze genetic polymorphisms of various candidate genes in association with viral clearance, disease progression or treatment response, and characterize the functional consequences of these polymorphisms in patients with well-defined clinical sequelae of HCV infection. We will also collect blood from patients with other forms of liver diseases (approximately 300) or normal volunteers (approximately 200) as controls. By identifying relevant host factors genetically and investigating their molecular interactions with HCV, we may gain additional insights into HCV pathogenesis and uncover new potential targets for vaccine development and treatment intervention.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients who have recovered from past HCV exposure (positive anti-HCV but negative HCV viremia and absent liver disease).

Patients with asymptomatic HCV infection (positive anti-HCV and HCV viremia, but persistently normal or minimally elevated ALT and normal or mild disease on liver biopsy).

Patients with active liver disease (positive anti-HCV and HCV viremia, persistently elevated ALT and/or moderate disease on liver biopsy).

Patients with active extrahepatic manifestations of HCV infection (cryoglobulinemia, glomerulonephritis, vasculitis, etc.).

Patients with rapidly progressive, severe liver disease and/or hepatocellular carcinoma.

Patients who have undergone or are undergoing treatment.

Patients from a single-source outbreak of HCV infections (in which the viral factors should be identical and the patients are often from a homogeneous population with less genetic variability).

HCV infected family members and twins.

Patients with other forms of liver disease including HBV infection, primary biliary cirrhosis, autoimmune hepatitis, nonalcoholic steatohepatitis, hemochromatosis, and Wilson's Disease, as well as normal volunteers.

EXCLUSION CRITERIA:

Adult subjects with a Hct of less than 30 or pediatric subjects less than 25 will be excluded.

Children with HCV infection younger than 2 years of age will be excluded.

Unaffected healthy volunteers who are minors are not eligible for this study.

Special Instructions:

Currently Not Provided

Keywords:

Cytokines

Treatment

Genetic Polymorphism

Chronic Hepatitis C

Mononuclear Cells

Recruitment Keyword(s):

None

Condition(s):

Hepatitis C

Liver Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Human leukocyte antigen and leprosy: study in northern Louisiana and review

Common west African HLA antigens are associated with protection from severe malaria

The immunogenetics of human infectious diseases

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/20/2008