Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC
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 reaching 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 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul 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
- •Both sexes
- •Older than 18 years old
- •A potentially sexual exposition to HIV
- •Accept to participate
排除标准
- •Pregnant women
- •The source case a person with HIV antiretroviral resistances
- •Persons with a treatment that is contraindicated with the drugs in the study
研究组 & 干预措施
Tenofovir, emtricitabine, Maraviroc
New postexposure prophylaxis (it is a combination drug)
干预措施: Tenofovir, emtricitabine, maraviroc (Drug)
Tenofovir, emtricitabine, lopinavir/r
Standard prophylaxis (it is a combination drug)
干预措施: Tenofovir, emtricitabine, lopinavir/r (Drug)
结局指标
主要结局
Proportion of patients reaching 28 days of postexposure prophylaxis.
时间窗: 28 days
Postexposure prophylaxis has to be used during 28 days to have effectiveness. It is thought that a shorter period of treatment does not prevent HIV infection according to animal models. Therefore, we will assess the proportion of patients who complete the total period of treatment in each arm of the study. The hypothesis is that a higher proportion of patients who take the medication with lower side effects will complete the 28 days of postexposure prophylaxis
次要结局
未报告次要终点
研究者
Felipe Garcia
PhD
Hospital Clinic of Barcelona