Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- hemodialysis extraction ratio of dolutegravir
研究概览
简要总结
Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.
详细描述
The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD.
Objective
to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Inadequate adherence to antiretroviral treatment (<90% in the week prior to inclusion).
- •Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.
研究组 & 干预措施
Dolutegravir 50mg/day per 5 days
Dolutegravir 50mg/day per 5 days
干预措施: Dolutegravir (Drug)
结局指标
主要结局
hemodialysis extraction ratio of dolutegravir
时间窗: Day 5
hemodialysis clearance of dolutegravir
时间窗: Day 5
次要结局
- percentage of patients presenting adverse events related to dolutegravir(From Baseline to day 5)