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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Collaborator: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: Etravirine

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. Negative ELISA for HIV-1 or HIV-2 at screening

3. Negative hepatitis B surface antigen at screening

4. Negative hepatitis C antibody at screening

5. 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

6. No history of diabetes, hypertension, or dyslipidemia

7. No anticipated changes or additions to other medical therapies during the course of the study

Exclusion Criteria:

1. Inability to provide written, informed consent

2. Known allergy/intolerance to etravirine or nitroglycerin

3. Absolute neutrophil count < 750cell/mL at screening

4. Hemoglobin <11g/dL at screening

5. Platelet count <100,000/mL at screening

6. Estimated creatinine clearance (per Cockcroft-Gault equation) <55 mL/min at screening

7. Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening

8. Breastfeeding at screening and during the course of the study

9. Hypotension, defined as SBP<90mmHg at time of each main study visit before brachial artery ultrasound measurements

10. 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

11. Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing

12. Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing

13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements

14. 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

15. History of migraine headaches

16. History of Raynaud's phenomenon

17. History of cardiac arrythmias

18. History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)

19. History of carotid bruits.

20. History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within one year of screening.