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.
|
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
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
Joseph M. McCune, MD, PhD, Principal Investigator, University of California at San Francisco
More Information
Click here for more information on HIV vaccines.
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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