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NCT00001109 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Mononuclear Cell Phenotyping in Normal Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001109
Other study ID # ACTG P1009
Secondary ID PACTG P1009
Status Completed
Phase N/A
First received November 2, 1999
Last updated July 29, 2008

Study information
Verified date October 2004
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 630
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 18 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Children's Hosp at Albany Med Ctr Albany New York
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Mt Sinai Hosp Med Ctr / Dept of Pediatrics Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States The Med Ctr Inc Columbus Georgia
United States Duke Univ Med Ctr Durham North Carolina
United States North Broward Hosp District Fort Lauderdale Florida
United States North Shore Univ Hosp Great Neck New York
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Univ of Mississippi Med Ctr Jackson Mississippi
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla 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 Los Angeles County - USC Med Ctr Los Angeles California
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of South Alabama Mobile Alabama
United States UMDNJ - Robert Wood Johnson Med School / Pediatrics New Brunswick New Jersey
United States Schneider Children's Hosp New Hyde Park New York
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 Bellevue Hosp / New York Univ Med Ctr New York New York
United States Harlem Hosp Ctr New York New York
United States Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States Palm Beach County Health Dept Riviera Beach Florida
United States Univ of Rochester Med Ctr Rochester New York
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States State Univ of New York at Stony Brook Stony Brook New York
United States Children's Hosp of Washington DC Washington District of Columbia
United States Howard Univ Hosp Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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 — View Citation

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