Completed

Mononuclear Cell Phenotyping in Normal Children

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What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

See all eligibility criteria
How is the trial designed

Observational
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 30, 2008
Sourced from a government-validated database.Claim as a partner

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.

NCT00001109
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 30, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

630 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 45 locations

Univ of Alabama at Birmingham - Pediatric

Birmingham, United StatesOpen Univ of Alabama at Birmingham - Pediatric in Google Maps

Univ of South Alabama

Mobile, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, United States

Los Angeles County - USC Med Ctr

Los Angeles, United States
Completed45 Study Centers