Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of patients dropping out before the 28 days of postexposure prophylaxis
研究概览
简要总结
As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).
Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe.
Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.
A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potentially sexual exposition to HIV
排除标准
- •Pregnancy
- •Source case with antiretroviral resistances
- •any treatment contraindicated with the drugs of study
研究组 & 干预措施
Tenofovir + emtricitabine + lopinavir/r
Standard postexposure prophylaxis combination
干预措施: Tenofovir, Emtricitabine, Lopinavir/r (Drug)
Tenofovir + Emtricitabine + Raltegravir
new postexposure prophylaxis combination
干预措施: Tenofovir, Emtricitabine, Raltegravir (Drug)
结局指标
主要结局
Proportion of patients dropping out before the 28 days of postexposure prophylaxis
时间窗: 28 days
Proportion of patients droppping out before the 28 days of postexposure prophylaxis considering death, lost to folow-up and stopping or changing treatment for any reason
次要结局
未报告次要终点
研究者
Felipe Garcia
MD
Hospital Clinic of Barcelona