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

Completed
Conditions
HIV Infections
HIV Seronegativity
Registration Number
NCT00001109
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
630
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (45)

North Broward Hosp District

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Fort Lauderdale, Florida, United States

Children's Hosp at Albany Med Ctr

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Albany, New York, United States

Cedars Sinai / UCLA Med Ctr

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Los Angeles, California, United States

Harbor - UCLA Med Ctr / UCLA School of Medicine

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Los Angeles, California, United States

Mt Sinai Hosp Med Ctr / Dept of Pediatrics

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Chicago, Illinois, United States

Texas Children's Hosp / Baylor Univ

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Houston, Texas, United States

Children's Hospital & Medical Center / Seattle ACTU

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Seattle, Washington, United States

Univ of Miami (Pediatric)

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Miami, Florida, United States

Duke Univ Med Ctr

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Durham, North Carolina, United States

UCSF / Moffitt Hosp - Pediatric

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San Francisco, California, United States

Univ of Alabama at Birmingham - Pediatric

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Birmingham, Alabama, United States

Univ of South Alabama

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Mobile, Alabama, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences

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La Jolla, California, United States

Los Angeles County - USC Med Ctr

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Los Angeles, California, United States

Children's Hosp of Washington DC

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Washington, District of Columbia, United States

Howard Univ Hosp

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Washington, District of Columbia, United States

Univ of Florida Health Science Ctr / Pediatrics

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Jacksonville, Florida, United States

Univ of Chicago Children's Hosp

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Chicago, Illinois, United States

The Med Ctr Inc

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Columbus, Georgia, United States

Palm Beach County Health Dept

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Riviera Beach, Florida, United States

Cook County Hosp

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Chicago, Illinois, United States

Chicago Children's Memorial Hosp

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Chicago, Illinois, United States

Johns Hopkins Hosp - Pediatric

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Baltimore, Maryland, United States

Tulane Univ / Charity Hosp of New Orleans

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New Orleans, Louisiana, United States

Children's Hosp of Boston

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Boston, Massachusetts, United States

Tulane Univ Hosp of New Orleans

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New Orleans, Louisiana, United States

Baystate Med Ctr of Springfield

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Springfield, Massachusetts, United States

Univ of Massachusetts Med School

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Worcester, Massachusetts, United States

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

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Newark, New Jersey, United States

Univ of Mississippi Med Ctr

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Jackson, Mississippi, United States

UMDNJ - Robert Wood Johnson Med School / Pediatrics

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New Brunswick, New Jersey, United States

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

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Newark, New Jersey, United States

Bronx Lebanon Hosp Ctr

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Bronx, New York, United States

North Shore Univ Hosp

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Great Neck, New York, United States

Montefiore Med Ctr Adolescent AIDS Program

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Bronx, New York, United States

Bellevue Hosp / New York Univ Med Ctr

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New York, New York, United States

Univ of Rochester Med Ctr

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Rochester, New York, United States

Harlem Hosp Ctr

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New York, New York, United States

Schneider Children's Hosp

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New Hyde Park, New York, United States

State Univ of New York at Stony Brook

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Stony Brook, New York, United States

Children's Hosp of Philadelphia

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Philadelphia, Pennsylvania, United States

San Juan City Hosp

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San Juan, Puerto Rico

Univ of Puerto Rico / Univ Children's Hosp AIDS

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San Juan, Puerto Rico

Ramon Ruiz Arnau Univ Hosp / Pediatrics

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Bayamon, Puerto Rico

Med Univ of South Carolina

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Charleston, South Carolina, United States

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