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Immune Function of Infants With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073229
Recruitment Status : Completed
First Posted : November 19, 2003
Last Update Posted : September 26, 2008
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease
HIV Infections

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Official Title: Killer Cells and Viral Load in Vertical HIV Infection
Study Start Date : July 2000
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants and children born to HIV infected women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073229

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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Katherine Luzuriaga, MD University of Massachusetts, Worcester

Publications of Results:
Other Publications:
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Responsible Party: Katherine Luzuriaga, MD, University of Massachusetts Identifier: NCT00073229     History of Changes
Other Study ID Numbers: 5R01AI032391-15 ( U.S. NIH Grant/Contract )
5R01AI032391-11 ( U.S. NIH Grant/Contract )
5R01AI032391-14 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2003    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vertical Transmission
Acute Infection
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases