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

Inclusion Criteria

• 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

Exclusion Criteria

• Inability to provide written, informed consent
• Known allergy/intolerance to etravirine or nitroglycerin
• Absolute neutrophil count 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 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.