The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.
We hypothesize that in HIV-uninfected subjects, etravirine 200mg twice daily for four weeks will have no effect on endothelial function. The primary objective of this study is to determine the effects of etravirine 200mg twice daily given for four weeks on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery, in HIV-uninfected subjects. Secondary objectives include determination of the effects of etravirine 200mg twice daily given for four weeks on safety measures, lipid fractions, HOMA-IR, blood pressure, inflammatory parameters, and endothelial activation parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
28
Two one-hundred mg tablets orally twice daily for four weeks
Infectious Diseases Research Center
Indianapolis, Indiana, United States
Flow-mediated Dilation (FMD) of the Brachial Artery
FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.
Time frame: Entry and four weeks
Lipid Fractions
Time frame: Four weeks
Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]
Time frame: Four weeks
Blood Pressure
Time frame: Four weeks
Inflammatory Biomarkers
Time frame: Four weeks
Endothelial Activation Biomarkers
Time frame: Four weeks
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