This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Design: Cross-sectional survey designed to evaluate the prevalence and severity of morphologic and metabolic abnormalities in HIV infected female youth and to assess the drug and non-drug factors related to these abnormalities. This study is designed to assess whether there exists significant differences in glucose metabolism, lipids, lactate, body composition and bone density between HIV infected and uninfected young women. Furthermore, this study will evaluate whether exposure to specific classes of antiretroviral (ARV) medications is associated with the metabolic and morphologic abnormalities among the HIV infected individuals in different ways. The study involves a one-time collection of medical history data, laboratory specimens, and physical assessments. This study will elucidate the need for further in-depth study to understand the pathophysiological effects of protease inhibitor (PI) and non-nucleoside analogue reverse transcriptase inhibitor (NNRT)-based therapies in young females. Sample size: One group of 50 HIV negative subjects and four groups of 50 HIV positive subjects. Population: HIV uninfected and infected females, aged 12 through 24 years, of Tanner Stage 4 or 5, non-pregnant and no pregnancy in past l2 months. Enrollment: Eligible subjects will be enrolled into the study non-randomly until target sample size is reached. Duration: One pre-entry visit and one on-study visit. The actual on-study visit may be completed over two (2) separate visits. Data Collection: Data will be collected through medical history abstraction and/or interview, physical assessments, blood and urine specimen collection, and anthropometric evaluation. Medical chart abstraction and all clinical and laboratory evaluations are to be completed within 30 days of initial pre-entry study visit. Objectives: 1)To determine the prevalence of abnormalities in glucose metabolism, lipids, lactate, body composition and bone density in HIV infected and HIV uninfected young women; 2) To compare the prevalence of these abnormalities among HIV uninfected young women, HIV infected young women who are antiretroviral naive,NNRTI experienced or protease inhibitor experienced, and non-protease, non-NNRTI experienced; 3) To examine the relationship between drug and non-drug factors and risk of specific alterations in this population.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-17
Application #
7376277
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
17
Fiscal Year
2006
Total Cost
$4,030
Indirect Cost
Name
Tulane University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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