Viewing Study NCT00073229



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Study NCT ID: NCT00073229
Status: COMPLETED
Last Update Posted: 2008-09-26
First Post: 2003-11-18

Brief Title: Immune Function of Infants With HIV
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Killer Cells and Viral Load in Vertical HIV Infection
Status: COMPLETED
Status Verified Date: 2008-09
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 observational study will evaluate data from infants born to HIV infected mothers in order to better characterize disease progression in early HIV infection
Detailed Description: The role of HIV-specific cytotoxic T-lymphocytes CTL in controlling viremia and protecting against disease progression following vertical infection may be dependent upon CTL functional responses as well as on the timing of detection magnitude and breadth of the responses Novel and sensitive assay systems MHC-peptide tetramers ELISPOT assays intracellular cytokine assays have enhanced the detection and characterization of virus-specific CTL responses in the peripheral blood This study will use these novel methods to examine the timing of detection magnitude specificity and in vitro functional properties of HIV-specific CTL in infants to evaluate the effects of potent combination antiretroviral therapy on HIV-specific CTL in infants and to evaluate the immunogenicity of recombinant pox-based vaccines in HIV infected infants with prolonged viral suppression following early potent combination antiretroviral therapy

Blood samples from infants born to HIV infected women will be obtained from infants enrolled in other HIV trials Generally samples will be obtained at birth Week 1 and Months 1 2 4 6 9 and 12

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
5R01AI032391-14 NIH None httpsreporternihgovquickSearch5R01AI032391-14
5R01AI032391-11 NIH None None