NCT03158077已完成不适用
Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks - KIRAL Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 14
- 主要终点
- Effectiveness: Proportion of patients with undetectable viral load
研究概览
简要总结
Retrospective observational study, multicentric with Spanish hospitals, in which a switching or change strategy with RAL and ABC / 3TC guidelines was used, in the48 weeks before the start of the study, in order to determine parameters of Effectiveness and security.
详细描述
The study consists of a 4-weeks data recording period, during which the follow-up information recorded by physicians in electronic or paper medical history will be analyzed from patients who opted for a change to that study pattern (RAL and ABC / 3TC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient with chronic infection with HIV-
- •Patients older than 18 years.
- •Patients in ART in whom RAL + ABC / 3TC has been initiated in at least 48 Weeks prior to the start of the study.
- •To have used the RAL + ABC / 3TC as a switching or change strategy
- •HIV virological control (CV ≤ 50 copies / ml) for at least 24 weeks prior to initiation of study regimen
排除标准
- •NAIVE patients who have started treatment with this regimen
- •Absence of digital or physical records of visits made for consultation
- •Patients who underwent treatment change within 48 weeks prior to study initiation
结局指标
主要结局
Effectiveness: Proportion of patients with undetectable viral load
时间窗: 48 weeks
Effectiveness in the virological control of RAL and ABC / 3TC
次要结局
- Safety: Adverse events.(24 weeks/48 weeks)
- Safety: frequency of adverse events leading to discontinuation of treatment.(24 weeks/48 weeks)
- Safety:serious adverse events(24 weeks/48 weeks)
- Safety: frequency of laboratory abnormalities.(24 weeks/48 weeks)
- Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL(48 weeks following the change)
- Safety-changes in renal function: changes in creatinine values(24 weeks following the change)
- Safety-changes in renal function: changes in glomerular filtration(24 weeks following the change)
- Safety: number of deaths(24 weeks/48 weeks)
- Safety: Changes in serum cholesterol(48 weeks following the change)
- Safety: Changes in serum triglycerides(48 weeks following the change)
研究者
研究点 (14)
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