EUCTR2017-005033-22-GB进行中（未招募）1 期
In patients taking Protease Inhibitors does switching to a Bictegravir, Tenofovir Alafenamide and Emtricitabine combination, reduce cardiovascular risk: An open-label, randomised, serial CT pilot study - HART-CT
niversity of Liverpool0 个研究点目标入组 100 人开始时间: 2019年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •HIV positive
- •Undetectable viral load on cART which contain protease inhibitors (duration >6 months at eligibility visit)
- •Age>40 years at recruitment visit
- •Stable cART*
- •No previous documented cardiovascular disease
- •Ability to give informed consent
- •Willingness to comply with all study requirements
- •No symptoms of overt cardiovascular disease**
- •* A definition of stable cART is no change to the medication regime in the preceding 6 months.
- •Well controlled hypertension is considered acceptable for recruitment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Active liver disease (previously diagnosed)
- •Renal disease (eGFR <30)
- •Any ongoing infection
- •Signficant ionising radiation in preceding 12 months*
- •Known or suspected cardiovascular disease**
- •High dose statin therapy (Atorvastatin 20mg or more, Rosuvastatin 20mg or more)
- •Pregnancy or planned pregnancy
- •Breast feeding
- •Allergy to iodine based contrast agent
- •Known drug resistance to NRTI or integrase
- •Any contraindication to BIC/FTC/TAF
- •*Significant ionising radiation should not exceed >25mSv from medical sources.
- •** A definition of cardiovascular disease includes documented angina, previous myocardial infarction or previous coronary revascularization.
研究者
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