Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir.
研究概览
简要总结
Some but not all observational studies have found that current exposure to abacavir is associated with increased risk of cardiovascular events such as myocardial infarction, stroke and cardiovascular death. This study aim to investigate possible adverse effect of abacavir on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients. The study is an open-labeled cross-over trial, where patients receiving antiretroviral therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa for a period of 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected
- •Can understand and sign written informed consent
- •Received one of the above mentioned antiretroviral regimens continuously ≥ 6 months
- •HIV RNA < 400 copies/mL for ≥ 6 months
排除标准
- •Receiving anticoagulant therapy, adenosine diphosphate (ADP) receptor inhibitors, aspirin or nonsteroidal antiinflammatory drugs (NSAIDs)
- •Previous ischemic heart disease, peripheral atherosclerotic disease or stroke
- •Coagulation disorder (e.g. hemophilia, factor V Leiden mutation)
- •Platelet count < 150 x 109/L during the past 6 months from inclusion
- •Estimated glomerular filtration rate (eGFR) <70 during the past 6 months from inclusion
- •Humane leukocyte antigen (HLA)-B*57:01 positive genotype
- •Hepatitis B or C positive during the past year from inclusion
- •Hypersensitivity to the active substances or to any of the excipients
研究组 & 干预措施
Tenofovir to abacavir
Patients switching from tenofovir (245 mg QD) to abacavir (600 mg QD)
干预措施: abacavir (600 mg QD) (Drug)
Abacavir to tenofovir
Patients switching from abacavir (600 mg QD) to tenofovir (245 mg QD)
干预措施: tenofovir (245 mg QD) (Drug)
结局指标
主要结局
Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir.
时间窗: before and after 90 days intervention
Differences in clot formation kinetics (thromboelastography) before and after switching between abacavir and tenofovir.
时间窗: before and after 90 days intervention
次要结局
- Concentration of plasma lipids(Before and after 90 days intervention)
- Fibrinogen(Before and after 90 days intervention)
- activated partial thromboplastin time (APTT)(90 days)
- international normalized ratio (INR)/Factor II, VII, X(Before and after 90 days intervention)
- High sensitivity C reactive protein (HS-CRP)(Before and after 90 days intervention)
- Syndecan-1(Before and after 90 days intervention)
- Platelet count(Before and after 90 days intervention)
- D-dimer(Before and after 90 days intervention)
- Antithrombine(Before and after 90 days intervention)
- Interleukin 6 (IL-6)(Before and after 90 days intervention)
- Soluble P-Selectin(Before and after 90 days intervention)
- soluble CD40 ligand (sCD40L)(Before and after 90 days intervention)
- Tissue plasminogen activator(Before and after 90 days intervention)
- Soluble E-selectin(Before and after 90 days intervention)
研究者
Jan Gerstoft
MD, DMSc, Professor
Rigshospitalet, Denmark