Immune Response to Hepatitis C Virus

NCT00165919 | Withdrawn

• 1 other identifier: 1358-2004
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C; HIV Infections

Keywords

Hepatitis C; HIV; Immunopathogenesis; HIV-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (1)

HCV+

No group or cohort; not a clinical trial

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

Interventions

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

HCV+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is not a clinical trial, but rather a basic science study using blinded human specimens. Individuals with HCV infection will be identified for enrollment into our study by our clinical collaborators at the Crawford Long Infectious Diseases Clinic-Emory University. Control individuals with no prior exposure to HCV will be identified and enrolled both from the Crawford Long clinics and from the investigative donor pool at the Emory Vaccine Center. Inclusion in the current study will be limited to individuals with HCV genotype 1 infection as well as uninfected normal controls as determined by antibody and viral load measurements.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Related Publications (1)

• Spellberg B, Edwards JE Jr. Type 1/Type 2 immunity in infectious diseases. Clin Infect Dis. 2001 Jan;32(1):76-102. doi: 10.1086/317537. Epub 2000 Dec 15.

  PMID: 11118387 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Interventions

Laboratories

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Arash Grakoui, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 13, 2013

Record last verified: 2013-11