The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29,612
- 主要终点
- Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen
研究概览
简要总结
The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older on the index date
- •Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,
- •Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim.
- •Have at least 6 months (180 days) of continuous enrollment prior to the index claim
排除标准
- •Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period
- •Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period
研究组 & 干预措施
Patient with Efavirenz exposure
Patient with Efavirenz exposure
干预措施: Efavirenz (Drug)
Patient without Efavirenz exposure
Patient without Efavirenz exposure
干预措施: Efavirenz (Drug)
结局指标
主要结局
Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen
时间窗: upto 1 to 5 years
cardiovascular events specifically based on incidence rate and compare the hazard (myocardial infarction, stroke,percutaneous coronary intervention, coronary artery bypass graft, and composite of aforementioned events) between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen
次要结局
未报告次要终点