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临床试验/NCT01886638
NCT01886638已完成4 期

Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study

Bayside Health1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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