NCT03198884已完成不适用
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Southern Illinois Healthcare Foundation0 个研究点目标入组 20 人开始时间: 2017年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Number of Participants With RNA <50 Copies/mL at 48 Weeks
研究概览
简要总结
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
- •Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
- •Resistance data (if applicable)
排除标准
- •Received a regimen of darunavir/ritonavir in combination with dolutegravir for <24 weeks duration
- •Patients receiving darunavir/ritonavir + DTG+NRTI's
- •Missing laboratory data in ≥2 study time points
- •Patients missing more than five doses over two weeks prior study visit
结局指标
主要结局
Number of Participants With RNA <50 Copies/mL at 48 Weeks
时间窗: 48 weeks
Our first primary endpoint evaluated the percent of study subjects with an RNA \<50 copies/mL at 48 weeks after initiation of the once daily two-drug regimen.
The Change in Serum Creatinine From Baseline to 48 Weeks.
时间窗: 48 weeks
A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects.
次要结局
- Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks.(48 weeks)
- Change in Mean CD4+ Cell Count From Baseline.(48 weeks)
- Incidence of Adverse Events.(48 weeks)
- Number of Grade 1 Adverse Events Reported(48 weeks)
- Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks(48 weeks)
研究者
John Verna
Physician Assistant
Southern Illinois Healthcare Foundation
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