NCT02588287已完成不适用
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in area under the plasma concentration (AUC) of tenofovir
研究概览
简要总结
This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r) and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate. The study consists of three visits: a screening visit and two abbreviated 4-hour pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks after initiating SOF/LDV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On tenofovir and a ritonavir-boosted PI for at least 30 days initiating HCV treatment with SOF/LDV
- •HCV RNA <48 copies/mL at most recent clinic visit
排除标准
- •eGFR < 60 ml/min
- •history of renal disease
- •Pregnant or planning pregnancy
- •Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes
结局指标
主要结局
Change in area under the plasma concentration (AUC) of tenofovir
时间窗: 4 weeks
Compare tenofovir AUC0-24 before and after administration of SOF/LDV
次要结局
- Change in concentrations of tenofovir-diphosphate(4 weeks)
- Change in Estimated Glomerular Filtration Rate (eGFR)(14 weeks)
研究者
研究点 (2)
Loading locations...
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