NCT00209352已完成3 期
Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- VZV infection at one year
研究概览
简要总结
The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.
详细描述
Herpes zoster infection occurs in 30% of allogeneic hematopoietic cell transplant (HCT) recipients who had a history of varicella zoster virus (VZV) infection. A safe and effective prevention strategy has not been established.
77 marrow allograft recipients at risk for VZV reactivation were randomized to oral acyclovir 800 mg twice daily or placebo given from day 30 until day 365 and were followed for toxicity and clinical evidence of herpes zoster infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years or older
- •Both sex (male or female)
- •Allogeneic transplant patient for hematologic malignancy or aplastic anemia
排除标准
- •Previous intolerance to acyclovir
- •Patients who are unavailable for follow-up
- •Patients in whom drug compliance may be a problem
- •Evidence of active VZV infection
- •VZV infection in the initial 1 month after transplant
- •Pregnant women, lactating women, or those not using adequate contraception
- •Creatinine > 3.0 mg/dl.
结局指标
主要结局
VZV infection at one year
次要结局
- VZV infection after discontinuation of prophylaxis
研究者
研究点 (2)
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