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Analysis of Immune Responses to HIV Vaccines



Analysis of Immune Responses to HIV Vaccines

For Condition: HIV Infections,Acquired Immunodeficiency Syndrome
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.
Details: 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:
Study Type:
  Observational,Natural History,Cross-Sectional,Defined Population,Retrospective/Prospective Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 200

Location and Contact Information:

Overall Study Official:
JosephMcCune,  Principal Investigator,  University of California at San Francisco

Core Immunology Laboratory *Recruiting*
San Francisco,  California,  94103
United States
Recruiting Barry  Bredt 415-206-5210


Additional Information:
Study ID Numbers:
  5 R01 AI47062-03; 
Study Start Date: April 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068978

Other Acquired Immunodeficiency Syndrome Studies:
1. Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

2. Pharmacokinetics of Intermittent Rifabutin and Isoniazid with Daily Efavirenz

3. A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant

4. The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir

5. Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients

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Analysis of Immune Responses to HIV Vaccines

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