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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001109 |
Purpose
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 |
|---|
|
HIV Infections HIV Seronegativity |
| Study Type: | Observational |
| Official Title: | Mononuclear Cell Phenotyping in Normal Children |
| Estimated Enrollment: | 630 |
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| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
A child may be eligible for this study if he/she:
Exclusion Criteria
A child will not be eligible for this study if he/she:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of South Alabama | |
| Mobile, Alabama, United States, 36604 | |
| Univ of Alabama at Birmingham - Pediatric | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| UCSF / Moffitt Hosp - Pediatric | |
| San Francisco, California, United States, 941430105 | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | |
| Los Angeles, California, United States, 905022004 | |
| Cedars Sinai / UCLA Med Ctr | |
| Los Angeles, California, United States, 900481804 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, District of Columbia | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20060 | |
| Children's Hosp of Washington DC | |
| Washington, District of Columbia, United States, 200102916 | |
| United States, Florida | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33311 | |
| 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 | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| Mt Sinai Hosp Med Ctr / Dept of Pediatrics | |
| Chicago, Illinois, United States, 60608 | |
| 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 | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| UMDNJ - Robert Wood Johnson Med School / Pediatrics | |
| New Brunswick, New Jersey, United States, 089030019 | |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10457 | |
| 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 | |
| Children's Hosp at Albany Med Ctr | |
| Albany, New York, United States, 12208 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 146420001 | |
| 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 | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Univ of Puerto Rico / Univ Children's Hosp AIDS | |
| San Juan, Puerto Rico, 009365067 | |
| Ramon Ruiz Arnau Univ Hosp / Pediatrics | |
| Bayamon, Puerto Rico, 00956 | |
| Study Chair: | W Shearer | |
| Study Chair: | H Rosenblatt |
More Information
| Study ID Numbers: | ACTG P1009, PACTG P1009 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001109 History of Changes |
| Health Authority: | United States: Federal Government |
|
Monocytes Flow Cytometry HIV Seronegativity Phenotype Lymphocyte Subsets |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |