Immune Response to Hepatitis C Virus

Emory University

Status: Withdrawn

Conditions: Hepatitis C; HIV Infections

Treatments: Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.

Study type: Observational

Funder types: Other

Identifiers

NCT00165919

1358-2004

Details and patient eligibility

About

The purpose of the study is to investigate the immune response to hepatitis C virus to determine why some people clear the virus and others develop chronic infection. Changes in immune response once hepatitis C therapy is begun will also be examined. If patients are also HIV+, the effect of antiretroviral therapy on the recovery of hepatitis C immunity will be investigated.

Full description

We will analyze the peripheral (blood) and intrahepatic (liver) immune response in hepatitis C infection in patients with clear hepatitis C infection and those who develop chronic infection. We hope to determine immune responses that are important for eliminating the infection. Currently, the treatments for hepatitis C are not effective for everyone. For those patients enrolled who begin hepatitis C treatment, we will evaluate the immune system of people who respond compared to those who do not respond. If the patient is HIV positive, the change in hepatitis C immune response once various HIV medicines (antiretrovirals) are started will also be examined. Any treatment for hepatitis C or HIV will be determined by the patient's primary physician and will not be affected by enrollment in the study.

Blood samples of ~70 cc will be obtained no more than once per week. Patients who begin hepatitis C therapy or antiretroviral therapy if HIV coinfected will provide serial specimens for examination. Patients who undergo liver biopsy as a part of their routine hepatitis care will provide a sample for further studies of the immune response to see if it is different in the liver compared to the blood.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

This is not a clinical trial.

Inclusion Criteria

• HCV infected and uninfected (controls)
• Women
• Minorities

Exclusion Criteria

• Children
• Individuals who cannot or will not provide informed consent

Trial design

0 participants in 1 patient group

HCV+

Description:

No group or cohort; not a clinical trial

Treatment:

Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.