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Analysis of Immune Responses to HIV Vaccines - Article


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Acquired Immune Deficiency Syndrome

Acquired Immunodeficiency Syndrome; AIDS; AIDS & HIV; AIDS - Neurological Complications; AIDS/HIV; HIV; HIV and AIDS; HIV/AIDS; HIV/AIDS & STDs; Human Immunodeficiency Virus; SIDA 




Clinical Trial: Analysis of Immune Responses to HIV Vaccines

This study is no longer recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.

Condition
Acquired Immunodeficiency Syndrome
HIV Infections

MedlinePlus related topics:  AIDS

Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Retrospective/Prospective Study

Official Title: Flow Cytometry Study of T Cell Responses to HIV Vaccines

Further Study Details: 

Expected Total Enrollment:  200

Study start: April 2003

Assays for HIV-specific human CD4 and CD8 T cell immunity are needed in order to evaluate the immune response to HIV vaccines. Such assays should be robust, reproducible, and amenable to high throughput analysis of clinical specimens. Cytokine flow cytometry (CFC) assays can reliably and specifically detect human CD4 and CD8 T cell responses to AIDS-related opportunistic infections, including those caused by cytomegalovirus, Mycobacterium tuberculosis, the Mycobacterium avium complex, cryptococcus, and human papillomavirus. The purpose of this study is to devise and evaluate a similar CFC assay for the detection and quantitation of CD4 and CD8 T cell responses against HIV.

This study will evaluate a “Gag-IFNg CFC” assay by comparing the results of this assay with results from other assays of immune phenotype and function in long-term nonprogressors, untreated patients with progressive HIV disease, and recipients of candidate HIV vaccines. The study will also examine HIV-specific immune responses in HIV infected individuals who appear to exhibit significant immune protection from HIV disease.

Participants in this study will be drawn from other studies currently underway. As a part of those studies, participants will have regular blood tests. Blood samples from those studies will be used in this study. No participants will be directly enrolled in this study.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Blood samples from 5 cohorts of HIV infected individuals and 2 cohorts of HIV uninfected individuals will be evaluated.

Varying stages of HIV disease are represented in these cohorts, including:

  • Individuals who have been exposed but who have not seroconverted
  • Individuals who have recently seroconverted
  • HAART-treated patients who receive immune modulators such as IL-2 and therapeutic immunization
  • HAART-treated patients who undergo structured treatment interruptions
  • HAART-treated patients who have durable suppression of viremia
  • HAART-treated patients who experience incomplete suppression of viremia
  • HAART-treated patients followed with careful drug adherence monitoring
  • Long-term nonprogressors
  • Untreated progressors

Location Information


California
      Core Immunology Laboratory, San Francisco,  California,  94103,  United States

Study chairs or principal investigators

Joseph M. McCune, MD, PhD,  Principal Investigator,  University of California at San Francisco   

More Information

Click here for more information on HIV vaccines.

Study ID Numbers:  5 R01 AI47062-03
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  September 12, 2003
ClinicalTrials.gov Identifier:  NCT00068978
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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November 28, 2009



Page Updated: October 15, 2009
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