Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Participants Who Stated (by Self-report) That They Had Side Effects
研究概览
简要总结
This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).
Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
- •Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy
排除标准
- •Known cardiovascular disease or Framingham risk score (FRS) ≥20%
- •Blood pressure ≥140/90
- •LDL cholesterol ≥160 (with FRS <10%), or ≥130 (with FRS 10-20%)
- •Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication
- •Cirrhosis or plasma ALT/AST levels >2x upper limit of normal
- •Chronic kidney disease and a creatinine >2.0mg/dL
- •Triglycerides >500mg/dL
研究组 & 干预措施
Lisinopril
Lisinopril 10mg once daily
干预措施: Lisinopril (Drug)
Lisinopril Placebo
Placebo pill (matched to lisinopril) once daily
干预措施: Lisinopril (Drug)
Pravastatin
Pravastatin 20mg once daily
干预措施: Pravastatin (Drug)
Pravastatin placebo
Placebo pill (matched to pravastatin) once daily
干预措施: Pravastatin (Drug)
结局指标
主要结局
Number of Participants Who Stated (by Self-report) That They Had Side Effects
时间窗: 4 months
Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.
Number of Participants Who Took >90% of Their Doses (by Pill Count)
时间窗: 4 months
The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'
Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
时间窗: Change from baseline to 4 months
The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
次要结局
- Changes TNFa (Tumor Necrosis Factor Alpha)(change from baseline to 4 months)
- Changes in Small Artery Elasticity(change from baseline to 4 months)
- Changes in Blood Pressure(change from baseline to 4 months)
- Changes in Blood Lipids(change from baseline to 4 months)
- Changes hsCRP (C-reactive Protein)(change from baseline to 4 months)
- Changes IL-6 (Interleukin-6)(change from baseline to 4 months)