Viewing Study NCT00068978



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Study NCT ID: NCT00068978
Status: COMPLETED
Last Update Posted: 2007-09-18
First Post: 2003-09-12

Brief Title: Analysis of Immune Responses to HIV Vaccines
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Flow Cytometry Study of T Cell Responses to HIV Vaccines
Status: COMPLETED
Status Verified Date: 2007-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5R01AI047062-03 NIH None httpsreporternihgovquickSearch5R01AI047062-03