Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- QT and corrected QT (QTc) intervals determined by a 12-leads ECG
研究概览
简要总结
This is a unicentric, two cohorts, observational transversal study.
The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.
详细描述
Primary objective:
The primary objective is to compare the QT/QTc intervals of HIV positive subjects treated with antiretroviral therapy and followed at the ambulatory HIV clinic and the QT/QTc intervals of :
- an outpatient HIV negative population from the same health center pre-admission one-day surgical clinic.
- the large HIV-free korean population studied in the ECG-ViEW database.
Secondary objectives :
- Evaluate the prevalence of QTc interval prolongation in the outpatient HIV positive population comparatively to the two HIV negative outpatient populations available from the one-day surgical clinic and the ECG-ViEW database.
- Evaluate risk factors associated with QTc interval prolongation in the outpatient HIV positive population compared to the outpatient HIV negative population and the population studied in the ECG-ViEW database.
- Compare the QT/QTc intervals and the prevalence of QTc interval prolongation of the outpatient HIV positive population currently on an antiretroviral regimen including a protease inhibitor versus those on an antiretroviral regimen without protease inhibitor.
- Compare the QT/QTc intervals among the outpatient HIV positive population treated with a protease inhibitor, in regard to the presence or the absence of certain genetic polymorphisms that may influence pharmacokinetic aspects of protease inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age eligible for study : 18-65 years old inclusively
- •Gender eligible for study : Both
排除标准
- •Hospitalised at the moment of recruitment
- •AIDS status
- •o Opportunistic infections acquired in the last 30 days before the date of recruitment
- •Age < 18 years old and > 65 years old
- •Follow-up care in an oncology clinic
- •Dialysis during the study period
- •Pregnancy
- •Without antiretroviral therapy
- •History of a myocardial infarction in the 3 weeks preceding recruitment
- •Have a pacemaker
- •Diagnosed with bundle branch block on ECG
- •Principal follow-up care outside of the CHUM HIV clinic
- •Refusal to participate in the study
结局指标
主要结局
QT and corrected QT (QTc) intervals determined by a 12-leads ECG
时间窗: Day 0 = Day 1 - This is a transversal study.
The QT/QTc intervals are determined by a 50 mm/s 12-leads ECG in the outpatient HIV positive population. The ECG is conducted in the morning, between 8:00 and 12:00 to limit the circadian variation. For the control group, the QT/QTc intervals are assessed through a registry of outpatient HIV negative subjects who had had a standard 12-leads ECG done in pre-admission one-day surgery clinic. In both groups, the corrected QT interval is calculated with the Bazett's formula and the Fridericia's formula.
次要结局
- To assess risk factors of QTc interval prolongation in both study groups(Day 0 = Day 1 - This is a transversal study.)
- Prevalence of QTc interval prolongation in both study groups(Day 0 = Day 1 - This is a transversal study.)
- Prevalence of QT/QTc intervals prolongation and associated risk factors among outpatient HIV subjects(Day 0 = Day 1 - This is a transversal study.)
- Evaluate the influence of genetic polymorphisms on PI's pharmacokinetic metabolisms in outpatient HIV positive subjects treated with a PI(Day 0 = Day 1 - This is a transversal study)