NCT00001109

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

July 30, 2008

Status Verified

October 1, 2004

First QC Date

November 2, 1999

Last Update Submit

July 29, 2008

Conditions

Keywords

MonocytesFlow CytometryHIV SeronegativityPhenotypeLymphocyte Subsets

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, 35233, United States

Location

Univ of South Alabama

Mobile, Alabama, 36604, United States

Location

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, 920930672, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Cedars Sinai / UCLA Med Ctr

Los Angeles, California, 900481804, United States

Location

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, 905022004, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

Children's Hosp of Washington DC

Washington D.C., District of Columbia, 200102916, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20060, United States

Location

North Broward Hosp District

Fort Lauderdale, Florida, 33311, United States

Location

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, 32209, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Palm Beach County Health Dept

Riviera Beach, Florida, 33404, United States

Location

The Med Ctr Inc

Columbus, Georgia, 31901, United States

Location

Mt Sinai Hosp Med Ctr / Dept of Pediatrics

Chicago, Illinois, 60608, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Chicago Children's Memorial Hosp

Chicago, Illinois, 606143394, United States

Location

Univ of Chicago Children's Hosp

Chicago, Illinois, 606371470, United States

Location

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, 701122699, United States

Location

Tulane Univ Hosp of New Orleans

New Orleans, Louisiana, 701122699, United States

Location

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, 212874933, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Univ of Massachusetts Med School

Worcester, Massachusetts, 016550001, United States

Location

Univ of Mississippi Med Ctr

Jackson, Mississippi, 39213, United States

Location

UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, 089030019, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

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

Newark, New Jersey, 07103, United States

Location

Children's Hosp at Albany Med Ctr

Albany, New York, 12208, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

Schneider Children's Hosp

New Hyde Park, New York, 11040, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 146420001, United States

Location

State Univ of New York at Stony Brook

Stony Brook, New York, 117948111, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10457, United States

Location

Montefiore Med Ctr Adolescent AIDS Program

The Bronx, New York, 10467, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Children's Hosp of Philadelphia

Philadelphia, Pennsylvania, 191044318, United States

Location

Med Univ of South Carolina

Charleston, South Carolina, 294253312, United States

Location

Texas Children's Hosp / Baylor Univ

Houston, Texas, 77030, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Ramon Ruiz Arnau Univ Hosp / Pediatrics

Bayamón, 00956, Puerto Rico

Location

Univ of Puerto Rico / Univ Children's Hosp AIDS

San Juan, 009365067, Puerto Rico

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

Related 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 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.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • W Shearer

    STUDY CHAIR
  • H Rosenblatt

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

July 30, 2008

Record last verified: 2004-10

Locations