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Trial NCT00001109

Resource URI: http://static.linkedct.org/resource/trials/NCT00001109
PropertyValue
linkedct:brief_title A Blood Test to Look at Cells of the Immune System in Healthy Children
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2560>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:condition <http://static.linkedct.org/resource/condition/5498>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 18 Years
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 630 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00001109
rdfs:label Trial NCT00001109
linkedct:lastchanged_date July 29, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
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linkedct:nct_id NCT00001109
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Mononuclear Cell Phenotyping in Normal Children
linkedct:org_study_id ACTG P1009
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/21329>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60573>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00001109>
linkedct:phase N/A
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/3471>
linkedct:secondary_id PACTG P1009
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design N/A
linkedct:study_type Observational
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 2004