Immune Response to Hepatitis C Virus

HIV Infections Clinical Trial

Official title:

Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00165919
• Other study ID #: 1358-2004
• Status: Withdrawn
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: November 12, 2013
• Start date: September 2005
• Est. completion date: September 2005

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

References & Publications (1)

Spellberg B, Edwards JE Jr. Type 1/Type 2 immunity in infectious diseases. Clin Infect Dis. 2001 Jan;32(1):76-102. Epub 2000 Dec 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No