Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
研究概览
详细说明
Background: Either LPV/r or EFZ plus a two nucleoside reverse-transcriptase inhibitors (NRTIs) are recommended by the current guidelines all around the world as the main background drugs for initial therapy of human immunodeficiency virus type 1 (HIV-1) infection. This indication is based in results of clinical trials, but patients who participate in these studies usually are greatly motivated to continue their prescribed regimen, and can be different from the "real life". Therefore, clinical practice often cannot reproduce published results.
Methods: A retrospective longitudinal cohort study was performed with 36 naïve-treatment patients, who started therapy with LPV/r or EFZ, with follow-up of 36 months. The primary endpoint was virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study. Effectiveness was examined comparing time to virological failure and CD4 recovery.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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SP
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Botucatu、SP、巴西、18603-790
- SAE e Hospital Dia Domingos Alves Meira
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV-1 infected naive-treatment patients
Exclusion Criteria:
- use of Anti-Retroviral Agents in the past
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Efavirenz Group
Naïve-treatment HIV patients, who started therapy with Efavirenz
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其他名称:
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有源比较器:Lopinavir/r Group
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Maintenance HIV RNA <50 copies/mL at the end oh 36 months
大体时间:36 months
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36 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Achieve HIV RNA <50 copies/mL at the first 6 months
大体时间:6 months
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6 months
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合作者和调查者
调查人员
- 首席研究员:Alexandre N Barbosa, MD, MSc、Botucatu School of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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