Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry
研究概览
简要总结
This is a substudy of MARCH, in which we are exploring the changes in the vascular endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure the changes in small and large arterial elasticity in participants of the MARCH study who switch to maraviroc-based regimens over 96 weeks of follow-up.
详细描述
Cardiovascular disease is increasingly recognised as a complication of HIV +/- therapies to treat it. Blood vessel elasticity, or compliance, can be depicted as the ability of the vessels to convert intermittent blood flow (cardiac ejection during systole) to continuous blood flow throughout the cardiac cycle. The compliance, or ability of vessels to accept energy, can be subdivided into elasticity of large and small vessels. Pulse wave tonometry is a non-invasive technique performed using a hand-held tonometer that generates two indices which correspond to large artery elasticity (LAE) and small artery elasticity (SAE). LAE and SAE estimates by pulse waveform analysis have previously shown greater correlation to Framingham risk when directly compared with other techniques such as flow-mediated diltation, and both LAE and SAE are associated with traditional cardiovascular risk factors (smoking, insulin resistance, hypertension).
It is unclear what the net effect of maraviroc, a chemokine-receptor blocker is on cardiovascular function.
The aims of this substudy are:
- To compare changes in the vascular endothelium between the control arm ((N(t)RTI) plus PI/r) and each of the maraviroc switch arms over 48 weeks of follow-up.
- To compare the changes in biomarkers and selected immunological markers between the control arm ((N(t)RTI) plus PI/r) and each of the maraviroc switch arms over 48 weeks of follow-up.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled prior to treatment in the parent study;
- •Provision of written, informed consent for participation in the substudy
排除标准
- •Known supraventricular tachycardia such as atrial flutter and/or fibrillation that precludes the measurement of pulse wave using tonometry.
研究组 & 干预措施
Arm 1
NRTI and PI
干预措施: NRTI + PI (Drug)
Arm 2
Maraviroc + PI
干预措施: maraviroc + PI (Drug)
Arm 3
maraviroc + NRTI
干预措施: maraviroc + NRTI (Drug)
结局指标
主要结局
Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry
时间窗: 96 weeks
measured at 6 timepoints week 0, 4, 12, 24, 48, 96
次要结局
- • Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry(96 weeks)
- • Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function(96 weeks)