A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth
3 other identifiers
observational
450
2 countries
38
Brief Summary
The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Metabolism, body composition, bone density, and other factors will be assessed in relationship to participants' exposure to highly active antiretroviral therapy (HAART).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2003
38 active sites
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
September 12, 2003
CompletedFirst Posted
Study publicly available on registry
September 16, 2003
CompletedStudy Start
First participant enrolled
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJanuary 7, 2014
January 1, 2014
September 12, 2003
January 6, 2014
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- For HIV uninfected participants (Group 1)
- HIV-1 negative (perinatally HIV-exposed but uninfected participants are eligible)
- For HIV infected participants (Groups 2 and 3)
- Mother-to-child (vertically) transmitted HIV infection
- Confirmed diagnosis of HIV-1 infection by two positive assays from two different samples
- For Group 2, cannot have taken a PI-containing regimen in the 12 months prior to study entry or have ever received a PI for 2 or more weeks
- For Group 3, must currently be taking the same PI-containing regimen taken continuously for at least 12 months prior to study entry
- For all participants
- Accessible medical and medications history
- Parent, legal guardian, or participant willing to give informed consent and willing to comply with study requirements
- Females who have begun menstruating must have negative pregnancy test
You may not qualify if:
- Receipt of certain medications, including growth hormone, megestrol acetate, anabolic agents, anticytokine agents, systemic ketoconazole, systemic glucocorticoids (except if receiving stable physiologic doses), or drugs to treat osteoporosis
- Type II diabetes mellitus and unable to omit medication prior to specimen collection
- Pregnancy within the last 12 months, currently pregnant, or breastfeeding
- History of eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233, United States
Usc La Nichd Crs
Alhambra, California, 91803, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90806, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103, United States
UCSF Pediatric AIDS CRS
San Francisco, California, 94110, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 90509, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06510, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32610-0296, United States
USF - Tampa NICHD CRS
Tampa, Florida, 33606, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, 30912, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, 60608, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
New Brunswick, New Jersey, 08901-1969, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203, United States
Nyu Ny Nichd Crs
New York, New York, 10016, United States
Metropolitan Hosp. Ctr.
New York, New York, 10029, United States
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
New York, New York, 10029, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794-8111, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
Lincoln Med. & Mental Health Ctr.
The Bronx, New York, 10451, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
Jacobi Med. Ctr.
The Bronx, New York, 10461, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, 27599-7220, United States
DUMC Ped. CRS
Durham, North Carolina, 27710, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00935, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Related Publications (7)
Wanke CA, Falutz JM, Shevitz A, Phair JP, Kotler DP. Clinical evaluation and management of metabolic and morphologic abnormalities associated with human immunodeficiency virus. Clin Infect Dis. 2002 Jan 15;34(2):248-59. doi: 10.1086/324744. Epub 2001 Dec 7.
PMID: 11740715BACKGROUNDSmith KY. Selected metabolic and morphologic complications associated with highly active antiretroviral therapy. J Infect Dis. 2002 May 15;185 Suppl 2:S123-7. doi: 10.1086/340200.
PMID: 12001033BACKGROUNDCurrier J, Carpenter C, Daar E, Kotler D, Wanke C. Identifying and managing morphologic complications of HIV and HAART. AIDS Read. 2002 Mar;12(3):114-9, 124-5.
PMID: 11966241BACKGROUNDCarr A, Samaras K, Thorisdottir A, Kaufmann GR, Chisholm DJ, Cooper DA. Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor-associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: a cohort study. Lancet. 1999 Jun 19;353(9170):2093-9. doi: 10.1016/S0140-6736(98)08468-2.
PMID: 10382692BACKGROUNDBockhorst JL, Ksseiry I, Toye M, Chipkin SR, Stechenberg BW, Fisher DJ, Allen HF. Evidence of human immunodeficiency virus-associated lipodystrophy syndrome in children treated with protease inhibitors. Pediatr Infect Dis J. 2003 May;22(5):463-5.
PMID: 12797313BACKGROUNDTebas P, Powderly WG, Claxton S, Marin D, Tantisiriwat W, Teitelbaum SL, Yarasheski KE. Accelerated bone mineral loss in HIV-infected patients receiving potent antiretroviral therapy. AIDS. 2000 Mar 10;14(4):F63-7. doi: 10.1097/00002030-200003100-00005.
PMID: 10770534BACKGROUNDJacobson DL, Lindsey JC, Gordon CM, Moye J, Hardin DS, Mulligan K, Aldrovandi GM; Pediatric AIDS Clinical Trials Group P1045 team. Total body and spinal bone mineral density across Tanner stage in perinatally HIV-infected and uninfected children and youth in PACTG 1045. AIDS. 2010 Mar 13;24(5):687-96. doi: 10.1097/QAD.0b013e328336095d.
PMID: 20168204RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Grace Aldrovandi, MD
University of Alabama at Birmingham
- STUDY CHAIR
Peggy Borum, PhD
University of Florida