Immune Function of Infants With HIV

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00073229
First received: November 18, 2003
Last updated: September 25, 2008
Last verified: September 2008

November 18, 2003
September 25, 2008
July 2000
June 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00073229 on ClinicalTrials.gov Archive Site
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Immune Function of Infants With HIV
Killer Cells and Viral Load in Vertical HIV Infection

This observational study will evaluate data from infants born to HIV infected mothers in order to better characterize disease progression in early HIV infection.

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.

Observational
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants and children born to HIV infected women
Both
up to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073229
5R01AI32391-15, 5R01 AI32391-11, 5R01AI32391-11, 5R01AI32391-14
No
Katherine Luzuriaga, MD, University of Massachusetts
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Katherine Luzuriaga, MD University of Massachusetts, Worcester
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP