The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
研究概览
简要总结
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.
详细描述
Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected (by positive HIV Ab or detectable HIV RNA level)
- •No ART for at least previous 3 months
- •Ready to start or re-start ART (regimen pre-chosen by patient and provider)
排除标准
- •Age < 18 years, or >60 years
- •Current aspirin use
- •Presence of known atherosclerotic CVD determined by:
- •Previous myocardial infarction
- •Significant coronary atherosclerosis by angiography
- •Coronary revascularization procedure (coronary stent or surgical bypass)
- •Previous cerebral vascular accident (stroke)
- •Ischemic cardiomyopathy
- •Carotid stenosis (>25% narrowing by carotid ultrasound)
- •Aortic aneurysm
- •Symptomatic peripheral vascular disease (claudication)
- •Surgical revascularization procedure of peripheral vessels
- •Hospitalization (within prior 2 weeks of study entry)
- •Concurrent self-limited bacterial infections (does not include chronic viral infections)
- •Clinical or pathologic diagnosis of systemic vasculitis
- •Active drug or alcohol use
研究组 & 干预措施
2
Start antiretroviral therapy (ART) immediately and initiate placebo pill daily
干预措施: Antiretroviral therapy (ART) (Drug)
1
Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily
干预措施: Aspirin 325mg (Drug)
1
Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily
干预措施: Antiretroviral therapy (ART) (Drug)
3
Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily
干预措施: Aspirin 325mg (Drug)
3
Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily
干预措施: Antiretroviral therapy (ART) (Drug)
4
Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily
干预措施: Antiretroviral therapy (ART) (Drug)
结局指标
主要结局
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
时间窗: changes from baseline to 6 months
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events
时间窗: 6 months
At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication
次要结局
未报告次要终点