An observational study in HIV Infections, sponsored by University of North Carolina, Chapel Hill. Completed at 13 sites in 2 countries. Open to male participants aged 12 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-01.
Sponsored by University of North Carolina, Chapel Hill · Observational
To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.
The study involves a one-time collection of health and medical history data, blood and urine specimens, and physical assessments. This study will elucidate the need for a further in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young men.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 250 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Approximately 250 subjects will be enrolled in the study. The number of subjects enrolled in each study group will be as follows: 50 HIV-negative subjects; 100 HIV-positive subjects who are antiretroviral therapy (ART) naïve; and two groups of up to 50 HIV-positive subjects each, one on an NNRTI-based regimen and the other on a PI-based regimen.
Group 1: HIV-Negative Control Subject Specific Inclusion Criteria
Exclusion Criteria:
HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5
HIV-positive, has never been on ART
HIV-positive, currently on a non-PI-containing NNRTI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of PI-containing regimen, and at least one year must have passed since receipt of last PI-containing regimen
HIV-positive, currently on a non-NNRTI-containing PI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of NNRTI-containing regimen, and at least one year must have passed since receipt of last NNRTI-containing regimen.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill