Clinical Trials


A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: September 12, 2003
Last updated: January 6, 2014
Last Verified: January 2014
History of Changes


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).

HIV Infections
HIV-Associated Lipodystrophy Syndrome
HIV Lipodystrophy Syndrome

Study Type: Observational
Official Title: Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 450
Study Start Date: October 2003
Study Completion Date: August 2005

Detailed Description:

Despite advances in HIV care associated with HAART, many patients on HAART regimens develop physical and metabolic problems, including changes in body fat distribution (lipodystrophy), osteopenia and osteoporosis, dyslipidemia, and hyperlactatemia. Early studies suggest that protease inhibitors (PIs) were directly responsible for HIV Lipodystrophy Syndrome (HLS) and skeletal complications in HAART-treated patients. This study will compare HIV infected, HAART-treated children and youth and their uninfected counterparts to make connections between HAART, HLS, and skeletal and metabolic problems. The study is the first to address the prevalence and risk assessment of these complications in children, and will be useful in predicting long-term prognosis in HIV patients who use or have used HAART.
There will be three groups in the study. Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention. Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen (Group 2) or a PI-containing regimen (Group 3). Screening evaluations will be conducted within 30 days prior to study entry. Study evaluations may be completed at study entry or over the course of up to 3 study visits. All participants will undergo whole body and regional DEXA scans (to assess bone density), measurements to determine sexual maturity, and blood work.



Ages Eligible for Study: 7 Years to 25 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  


Inclusion Criteria
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

  • Exclusion Criteria
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00069004


United States, Alabama
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
United States, California
Usc La Nichd Crs
Alhambra, California, United States, 91803
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90806
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
San Francisco, California, United States, 94110
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90509
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Children's National Med. Ctr., ACTU
Washington, District of Columbia, United States, 20010
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33316
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, United States, 32610-0296
Tampa, Florida, United States, 33606
United States, Georgia
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States, 30912
United States, Illinois
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608
Chicago Children's CRS
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 21287
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
United States, New Jersey
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
New Brunswick, New Jersey, United States, 08901-1969
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States, 07103
United States, New York
Lincoln Med. & Mental Health Ctr.
Bronx, New York, United States, 10451
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
Jacobi Med. Ctr.
Bronx, New York, United States, 10461
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Metropolitan Hosp. Ctr.
New York, New York, United States, 10029
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
New York, New York, United States, 10029
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11794-8111
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
United States, North Carolina
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States, 27599-7220
Durham, North Carolina, United States, 27710
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Study Chair: Grace Aldrovandi, MD University of Alabama at Birmingham
Study Chair: Peggy Borum, PhD University of Florida
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00069004   History of Changes  
Other Study ID Numbers: P1045  
  PACTG P1045  
Study First Received: September 12, 2003  
Last Updated: January 6, 2014  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV-Associated Lipodystrophy Syndrome
HIV Lipodystrophy Syndrome
Treatment Experienced

Additional relevant MeSH terms:
HIV-Associated Lipodystrophy Syndrome
Bone Diseases, Metabolic
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