Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Flow-mediated Dilation (FMD) of the Brachial Artery
研究概览
简要总结
The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Flow-mediated Dilation (FMD) of the Brachial Artery
时间窗: Entry and four weeks
FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.
次要结局
- Lipid Fractions(Four weeks)
- Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)](Four weeks)
- Blood Pressure(Four weeks)
- Inflammatory Biomarkers(Four weeks)
- Endothelial Activation Biomarkers(Four weeks)