EUCTR2020-004454-30-ES进行中（未招募）1 期
Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease - DORA-HD
Fundació FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència0 个研究点目标入组 8 人开始时间: 2020年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males and females aging = 18 years.
- •2.Documented HIV infection.
- •3.Stable antiretroviral treatment for at least 2 weeks prior to enrolment.
- •4.Optimal adherence to antiretroviral treatment, defined as less than 2 missed doses within the previous week.
- •5.End-stage renal disease in renal replacement therapy with periodic hemodialysis.
- •6.Agree with the study procedures and signature of the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Evidence or clinical suspicion that the patient will not be able to comply with the study protocol.
- •2.Hypersensitivity to doravirine
- •3.Concomitant therapy within the previous 4 weeks with any of the following drugs:
- •- Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- •- Androgen receptor inhibitor: enzalutamide
- •- Antimycobacterials: rifampin, rifapentine
- •- Cytotoxic agent: mitotane
- •- St. John’s wort (Hypericum perforatum)
- •4.Females who are pregnant or breastfeeding.
- •5.ALT and/ or AST = 4 times the upper limit of normal (ULN) at screening.
- •6.Hemoglobin < 7,5 g/dL at screening.
研究者
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