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

Completed · Phase 1

Conditions studied: Endothelial Function, Lipids, Insulin Resistance, Inflammation, HIV Infections

In brief

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

Key facts

Study ID

NCT00871234

Run by

Indiana University

People needed

28

Starts

2009-04-01

Expected to finish

2010-07-01

Last updated by the study team

2011-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older
• Negative ELISA for HIV-1 or HIV-2 at screening
• Negative hepatitis B surface antigen at screening
• Negative hepatitis C antibody at screening
• For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study
• No history of diabetes, hypertension, or dyslipidemia
• No anticipated changes or additions to other medical therapies during the course of the study

You may not qualify if…

• Inability to provide written, informed consent
• Known allergy/intolerance to etravirine or nitroglycerin
• Absolute neutrophil count < 750cell/mL at screening
• Hemoglobin <11g/dL at screening
• Platelet count <100,000/mL at screening
• Estimated creatinine clearance (per Cockcroft-Gault equation) <55 mL/min at screening
• Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening
• Breastfeeding at screening and during the course of the study
• Hypotension, defined as SBP<90mmHg at time of each main study visit before brachial artery ultrasound measurements
• Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (>10mg/day of prednisone or the equivalent), or anabolic steroids within 30 days of each screening visit or each main study visit
• Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
• Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
• Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to each screening and study visit
• History of migraine headaches
• History of Raynaud's phenomenon
• History of cardiac arrythmias
• History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
• History of carotid bruits.
• History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within one year of screening.

Where it is running

• Infectious Diseases Research Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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