Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maintenance HIV RNA <50 copies/mL at the end oh 36 months
研究概览
简要总结
Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •HIV-1 infected naive-treatment patients
排除标准
- •use of Anti-Retroviral Agents in the past
研究组 & 干预措施
Efavirenz Group
Naïve-treatment HIV patients, who started therapy with Efavirenz
干预措施: First-line Antiretroviral Therapy (Drug)
Lopinavir/r Group
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
干预措施: First-line Antiretroviral Therapy (Drug)
结局指标
主要结局
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
时间窗: 36 months
次要结局
- Achieve HIV RNA <50 copies/mL at the first 6 months(6 months)