Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay
研究概览
简要总结
HIV positive patients have a two fold increased risk of developing cardiovascular disease (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both HIV and the side effects from anti-HIV medications.
Abacavir (an important component of current HIV treatment regimens) is one medication shown to be associated with an increase the risk of heart attacks in some studies. The mechanism by which abacavir does this is unknown.
We hypothesise that abacavir is leading to heart disease by interacting with platelets, which then form blood clots within the arteries supplying the heart, the subsequent blockage of the artery causing a heart attack.
This study aims to determine if abacavir increases the activity (or "stickiness") of platelets, and thus provide evidence as to how it may be promoting heart attacks.
It will consist of 23 HIV positive men who currently have well controlled HIV. Participants will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood sample to assess platelet activity will be taken at baseline, following the 15 days of therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period (to determine if any effects are reversible).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •HIV positive
- •Stable non-abacavir containing anti-retroviral regimen
- •Undetectable HIV Viral load
排除标准
- •HLA-B*57*01 allele positivity
- •Previous allergy to abacavir
- •Known cardiovascular disease
- •High Baseline cardiovascular risk (Framingham risk score > 20%)
- •Current or recent antiplatelet therapy
- •Pre-existing platelet or bleeding disorder (i.e. Thrombophilia, Thrombocytopenia, Von willebrands disease, Haemophilia)
- •Significant Chronic liver disease
- •Current Methadone use
研究组 & 干预措施
Abacavir
Abacavir 600mg (as two 300mg tablets) once daily for 15 days
干预措施: Abacavir (Drug)
结局指标
主要结局
Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay
时间窗: Baseline, day 15 and day 48
次要结局
- Platelet specific collagen receptor glycoprotein VI (GPVI)(Baseline, Day 15 and Day 48)
- Platelet aggregation(Baseline, Day 15 and day 48)
