A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
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|ClinicalTrials.gov Identifier: NCT00069004|
Recruitment Status : Completed
First Posted : September 16, 2003
Last Update Posted : January 7, 2014
|Condition or disease|
|HIV Infections HIV-Associated Lipodystrophy Syndrome HIV Lipodystrophy Syndrome Lipodystrophy Dyslipidemia Osteoporosis Osteopenia|
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.
|Study Type :||Observational|
|Enrollment :||450 participants|
|Official Title:||Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth|
|Study Start Date :||October 2003|
|Actual Study Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069004
Show 38 Study Locations
|Study Chair:||Grace Aldrovandi, MD||University of Alabama at Birmingham|
|Study Chair:||Peggy Borum, PhD||University of Florida|