Immune Response to Hepatitis C Virus

Withdrawn

• Conditions: HIV Infections; Hepatitis C
• Interventions: Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.

• Registration Number: NCT00165919
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV+	None. Not a clinical trial. Specimens taken for basic research in laboratory.	No group or cohort; not a clinical trial

Primary Outcome Measures

Name	Time	Method
This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.	no outcomes measured

Secondary Outcome Measures

Name	Time	Method
This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.	no outcomes to measure