A Blood Test to Look at Cells of the Immune System in Healthy Children
NCT ID: NCT00001109
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
630 participants
OBSERVATIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* 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
* Is pregnant or breast-feeding.
* Has already completed this study once before.
* Is taking prescription medications other than prescription vitamins.
1 Day
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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W Shearer
Role: STUDY_CHAIR
H Rosenblatt
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Univ of South Alabama
Mobile, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Palm Beach County Health Dept
Riviera Beach, Florida, United States
The Med Ctr Inc
Columbus, Georgia, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Tulane Univ Hosp of New Orleans
New Orleans, Louisiana, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Shearer WT, Rosenblatt HM, Gelman RS, Oyomopito R, Plaeger S, Stiehm ER, Wara DW, Douglas SD, Luzuriaga K, McFarland EJ, Yogev R, Rathore MH, Levy W, Graham BL, Spector SA; Pediatric AIDS Clinical Trials Group. Lymphocyte subsets in healthy children from birth through 18 years of age: the Pediatric AIDS Clinical Trials Group P1009 study. J Allergy Clin Immunol. 2003 Nov;112(5):973-80. doi: 10.1016/j.jaci.2003.07.003.
Other Identifiers
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PACTG P1009
Identifier Type: -
Identifier Source: secondary_id
ACTG P1009
Identifier Type: -
Identifier Source: org_study_id