Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 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
研究组 & 干预措施
Tenofovir PK before and after SOF/LDV
干预措施: Blood draws for tenofovir PK, renal function (Other)
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)