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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00001109
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 30, 2008
Information provided by:

Study Description
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.

Condition or disease
HIV Infections HIV Seronegativity

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.

Study Design

Study Type : Observational
Estimated Enrollment : 630 participants
Official Title: Mononuclear Cell Phenotyping in Normal Children

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001109

  Hide Study Locations
United States, Alabama
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Univ of South Alabama
Mobile, Alabama, United States, 36604
United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
United States, District of Columbia
Children's Hosp of Washington DC
Washington, District of Columbia, United States, 200102916
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
United States, Florida
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
United States, Georgia
The Med Ctr Inc
Columbus, Georgia, United States, 31901
United States, Illinois
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States, 60608
Cook County Hosp
Chicago, Illinois, United States, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Tulane Univ Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, Mississippi
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
United States, New Jersey
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, United States, 10467
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Harlem Hosp Ctr
New York, New York, United States, 10037
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: W Shearer
Study Chair: H Rosenblatt
More Information

ClinicalTrials.gov Identifier: NCT00001109     History of Changes
Other Study ID Numbers: ACTG P1009
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: July 30, 2008
Last Verified: October 2004

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Flow Cytometry
HIV Seronegativity
Lymphocyte Subsets

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases