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| Descriptive Information Fields | |||||||||
| Brief Title † | A Blood Test to Look at Cells of the Immune System in Healthy Children | ||||||||
| Official Title † | Mononuclear Cell Phenotyping in Normal Children | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | |||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections HIV Seronegativity |
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| Intervention † | |||||||||
| MEDLINE PMIDs | 14610491 | ||||||||
| Links | Haga clic aquí para ver información sobre este ensayo clínico en español.  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 630 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria A child may be eligible for this study if he/she:
Exclusion Criteria A child will not be eligible for this study if he/she:
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| Gender | Both | ||||||||
| Ages | up to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Puerto Rico | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00001109 | ||||||||
| Organization ID | ACTG P1009 | ||||||||
| Secondary IDs †† | PACTG P1009 | ||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | October 2004 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | July 29, 2008 | ||||||||
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