A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
- Conditions
- HIV InfectionsHIV-Associated Lipodystrophy SyndromeHIV Lipodystrophy SyndromeLipodystrophyDyslipidemiaOsteoporosisOsteopenia
- Registration Number
- NCT00069004
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
🇺🇸Chicago, Illinois, United States
South Florida CDTC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
🇺🇸New Brunswick, New Jersey, United States
Lincoln Med. & Mental Health Ctr.
🇺🇸Bronx, New York, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Metropolitan Hosp. Ctr.
🇺🇸New York, New York, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
St. Jude/UTHSC CRS
🇺🇸Memphis, Tennessee, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
🇺🇸Augusta, Georgia, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
🇺🇸Gainesville, Florida, United States
Rutgers - New Jersey Medical School CRS
🇺🇸Newark, New Jersey, United States
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
🇺🇸Chapel Hill, North Carolina, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States
UCSD Mother-Child-Adolescent Program CRS
🇺🇸San Diego, California, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
UAB, Dept. of Ped., Div. of Infectious Diseases
🇺🇸Birmingham, Alabama, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
USF - Tampa NICHD CRS
🇺🇸Tampa, Florida, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
🇺🇸New York, New York, United States
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
Usc La Nichd Crs
🇺🇸Alhambra, California, United States
Jacobi Med. Ctr.
🇺🇸Bronx, New York, United States