NCT00871234

Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study

Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.

Detailed description

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.

Conditions

• Endothelial Function
• Lipids
• Insulin Resistance
• Inflammation
• HIV Infections

Interventions

Type	Name	Description
DRUG	Etravirine	Two one-hundred mg tablets orally twice daily for four weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-03-01
• Completion: 2010-07-01
• First posted: 2009-03-30
• Last updated: 2011-01-07
• Results posted: 2011-01-05

Locations

1 site across 1 country: United States