NCT01585038已完成4 期
A Randomized Controlled Trial Comparing Efavirenz With Rilpivirine on Changes in Endothelial Function, Inflammatory Markers, and Oxidative Stress in HIV-uninfected Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Flow-mediated Dilation of the Brachial Artery
研究概览
简要总结
The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.
详细描述
This is a randomized, controlled, open-label, single-center study comparing the effects of efavirenz (EFV) versus rilpivirine (RPV) on endothelial function in a total of 40 HIV-uninfected healthy volunteers (20 in each arm) at the Indiana University Medical Center. Enrolled subjects will have their brachial artery flow-mediated dilation (FMD), a measure of endothelial function, and other cardiovascular, inflammatory, and oxidative stress parameters measured at baseline and again after 4 weeks of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •For men who are capable of impregnating a female sexual partner, a willingness to use condoms with spermicidal gel for all sexual contacts during the course of the study
- •No documented history of or receipt of medications being used to treat any psychiatric disorder, including (but not limited to) depression, dysthymia, mania, bipolar disease, schizophrenia, or previous suicidal ideation/attempts
- •No anticipated changes or additions to other medical therapies during the course of the study
- •No documented history of seizure disorder
排除标准
- •Inability to provide written, informed consent
- •Known allergy/intolerance to rilpivirine, efavirenz, 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
- •Serum glucose > 200mg/dL at screening
- •Serum total cholesterol > 190mg/dL at screening
- •Breastfeeding at screening or during the course of the study
- •Hypotension, defined as SBP < 90mmHg at time of each main study visit before brachial artery ultrasound measurements
- •Hypertension, defined as SBP > 160mmHg at time of screening
- •Receipt of investigational agents within 30 days of each screening visit or anticipated use during the trial
- •Receipt of cytotoxic chemotherapy within 30 days of each screening visit or anticipated use during the trial
- •Receipt of systemic glucocorticoids (> 10mg/day of prednisone or the equivalent), inhaled/nasal/topical fluticasone, or anabolic steroids within 30 days of each screening visit or anticipated use during the trial
- •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 or study personnel, 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 45 days of screening
- •Drugs/therapies with significant CYP 450 induction or inhibition potential at screening
- •Use of antacids, H2-blockers, or proton pump inhibitors within 30 days of screening or anticipated use of these drugs during the trial
- •Any history of injection or illicit drug use
- •Presence of fever, defined as an oral or tympanic temperature > 100.3F, at either the Entry or Closeout Visits
- •On the PHQ-9 depression questionnaire at screening, a total score of more than 9 or any score over 0 on question 9.
研究组 & 干预措施
Efavirenz
Active Comparator
Efavirenz 600mg given nightly without food for 30 days
干预措施: Efavirenz (Drug)
Rilpivirine
Active Comparator
Rilpivirine 25mg given daily with meals for 30 days
干预措施: Rilpivirine (Drug)
结局指标
主要结局
Change in Flow-mediated Dilation of the Brachial Artery
时间窗: Change from baseline to 4 weeks
This is a measure of in vivo endothelial function
次要结局
- Oxidative Stress Markers(Change from baseline to 4 weeks)
- Inflammatory Markers(Change from baseline to 4 weeks)
- Endothelial Activation Markers(Change from baseline to 4 weeks)
研究者
Samir K Gupta, MD, MS
Associate Professor of Medicine
Indiana University
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV DrugsHIV InfectionsNCT00005000Agouron Pharmaceuticals200
已完成
4 期
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV PatientsHIVNCT00299091Germans Trias i Pujol Hospital31
Unknown
4 期
Favipiravir in Hospitalized COVID-19 PatientsCOVID-19NCT04359615Shahid Beheshti University of Medical Sciences40
已完成
4 期
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 PatientsHIV-1 InfectionNCT01989910Taipei Veterans General Hospital, Taiwan107
已完成
3 期
A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-BPatients With LC-BNCT00672867Bukwang Pharmaceutical102