HIV Infections Clinical Trial
Official title:
Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen
This is a substudy of ACTG A5142. The purpose of this substudy is to evaluate blood vessel function in HIV-infected patients taking anti-HIV drugs.
Endothelial dysfunction, assessed by measurement of brachial artery reactivity, is
associated with coronary artery disease. Previous studies showed that patients taking HIV
protease inhibitors (PIs) had a buildup of fatty deposits in their arteries and impaired
flow-mediated vasodilation of the brachial artery, whereas endothelial function was normal
in HIV-infected individuals not taking PIs. The effect of three different antiretroviral
regimens on endothelial function in antiretroviral naïve HIV-infected patients will be
examined in this substudy.
Patients in this substudy will have Brachial Artery Reactivity Tests (BARTs), which are
painless ultrasound tests of an artery in the lower arm. Brachial artery reactivity will be
measured at entry and at 4 and 24 weeks after patients are randomized to one of three
open-label drug regimens in ACTG A5142. Brachial artery reactivity in response to two
vasoactive stimuli (flow-mediated and nitroglycerin) will be assessed by measuring brachial
artery diameter and flow velocity. Blood will be drawn at Weeks 4 and 24 for insulin and
lipid tests. Patients will fast and refrain from tobacco and caffeine use for at least 8
hours prior to each study visit. For the duration of the substudy, patients will be asked
not to change the amount of fruits, juices, antioxidants, and tea that they consume.
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