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Home > "A" Clinical Trials Conditions > A Blood Test to Look at Cells of the Immune System in Healthy Children  A Blood Test to Look at Cells of the Immune System in Healthy Children
A Blood Test to Look at Cells of the Immune System in Healthy Children
For Condition: HIV Infections,HIV Seronegativity
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History, Cross-Sectional
Minimum Age/Maximum Age: /18 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 630
Location and Contact Information:
Overall Study Official:
WShearer, Study Chair,
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Tulane Univ Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Additional Information:
Study ID Numbers: ACTG P1009; PACTG P1009
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001109
Other Hiv Seronegativity Studies:
1. Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
2. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS
3. Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
4. A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or are Intolerant of Pyrimethamine-Sulfadiazine
5. A Study of DTC in Patients With AIDS and AIDS Related Complex
Related Studies:
Other HIV Seronegativity Clinical Trials
Other Clinical Trials
Other San Juan Clinical Trials
A Blood Test to Look at Cells of the Immune System in Healthy Children
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