HIV InfectionsNCT00001109
A Blood Test to Look at Cells of the Immune System in Healthy Children
An observational study of HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- How many people
- 630 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States42 sites
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
Cook County Hosp
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
The Med Ctr Inc
Columbus, Georgia, 31901
Duke Univ Med Ctr
Durham, North Carolina, 277103499
North Broward Hosp District
Fort Lauderdale, Florida, 33311
North Shore Univ Hosp
Great Neck, New York, 11021
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
Univ of Miami (Pediatric)
Miami, Florida, 33161
Univ of South Alabama
Mobile, Alabama, 36604
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
Schneider Children's Hosp
New Hyde Park, New York, 11040
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Tulane Univ Hosp of New Orleans
New Orleans, Louisiana, 701122699
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Harlem Hosp Ctr
New York, New York, 10037
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
Univ of Rochester Med Ctr
Rochester, New York, 146420001
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
Puerto Rico3 sites
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
San Juan City Hosp
San Juan, 009367344
About this study
Official title: Mononuclear Cell Phenotyping in Normal Children
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.
Read the 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.
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Monocytes, Flow Cytometry, HIV Seronegativity, Phenotype, Lymphocyte Subsets
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 630 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- W Shearer, Study chairH Rosenblatt, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001109
- Sponsor's protocol ID
- ACTG P1009
- Other IDs
- PACTG P1009
- Status last verified
- Oct 2004
- First submitted
- 2 Nov 1999
- Last updated
- 30 Jul 2008
- Results posted
- No
Publications
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.
PubMed 14610491
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mononuclear Cell Phenotyping in Normal Children
- ClinicalTrials.gov ID
- NCT00001109
- Acronym / sponsor ID
- ACTG P1009
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Monocytes, Flow Cytometry, HIV Seronegativity, Phenotype, Lymphocyte Subsets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Is pregnant or breast-feeding.
- Has already completed this study once before.
- Is taking prescription medications other than prescription vitamins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
- Results publication: PubMed 14610491Shearer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W Shearer study chair
H Rosenblatt study chair
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2008.