A Blood Test to Look at Cells of the Immune System in Healthy Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001109
First received: November 2, 1999
Last updated: July 29, 2008
Last verified: October 2004
  Purpose

The purpose of this study is to learn more about some of the immune cells in the blood (CD4 cells, for example) of healthy children in order to better understand the differences in the blood cells of children infected with HIV.

Because children's bodies are still developing, their cells are different from those of adults, and their bodies respond differently to infections such as HIV. In order to understand how immune cells grow and mature so that they can fight HIV, it is important to see how these cells behave in normal children.


Condition
HIV Infections
HIV Seronegativity

Study Type: Observational
Official Title: Mononuclear Cell Phenotyping in Normal Children

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 630
Detailed Description:

Early in life, the cells involved in immune selection differentiate into CD4+ and CD8+ cells. Currently there is insufficient information on the cell maturation and activation of these peripheral blood mononuclear cell (PBMC) subsets in normal children. The critical need for this information has been brought about by the pediatric HIV/AIDS epidemic, which requires the measurement of peripheral blood CD4+ T cells and other cells types for interpretation of HIV disease progression. The immunopathogenesis of pediatric HIV infection differs from that in adults but is not well understood. In order to better understand HIV disease progression in HIV-infected children, these PBMC subsets must be studied in normal children so that control values can be established.

Healthy infants, children, and adolescents presenting for routine care or elective surgery have a single blood sample obtained. Blood is used for complete blood count, peripheral blood mononuclear cell flow analysis for surface markers, and plasma and cell storage. Demographic information including age, sex, race, and ethnicity is obtained at the time of the blood draw. The reason for the patient's visit is also documented. No study drugs are administered or supplied as part of this study. Statistical analysis is used to estimate the median distribution of each CD4 and CD8 subset.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

A child may be eligible for this study if he/she:

  • Is 0 - 18 years old.
  • Is HIV-negative and is born to an HIV-negative mother.
  • Is healthy (no serious infection or disease).
  • Has signed informed consent of a parent or legal guardian if under 18.

Exclusion Criteria

A child will not be eligible for this study if he/she:

  • Is pregnant or breast-feeding.
  • Has already completed this study once before.
  • Is taking prescription medications other than prescription vitamins.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001109

  Show 45 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: W Shearer
Study Chair: H Rosenblatt
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001109     History of Changes
Other Study ID Numbers: ACTG P1009, PACTG P1009
Study First Received: November 2, 1999
Last Updated: July 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Monocytes
Flow Cytometry
HIV Seronegativity
Phenotype
Lymphocyte Subsets

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 21, 2014