Status:
COMPLETED
Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
Endothelial Function
Lipids
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00871234
Start Date
April 1 2009
End Date
July 1 2010
Last Update
January 7 2011
Active Locations (1)
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1
Infectious Diseases Research Center
Indianapolis, Indiana, United States, 46202