NCT02198443已完成4 期
Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.
Fundacion Clinic per a la Recerca Biomédica1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2015年6月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
研究概览
简要总结
The main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (PEP) for HIV,
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
- 否
入选标准
- •Age greater than 18 years
- •Have been exposed to HIV, non-occupational and meets the requirements of current recommendations to start with three antiretroviral drugs PEP
- •that adequately informed consent in writing to participate in the study and undergo testing and exploration that entails
排除标准
- •pregnant women, lactating, or those intend become pregnant during the study period.
- •subjects who are known or suspected case presents the source resistors to one of the drugs of the pattern of study
- •contraindicated treatment with the study drugs, or products under investigation
研究组 & 干预措施
Tenofovir+emtricitabine
Active Comparator
干预措施: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra) (Drug)
Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
Experimental
干预措施: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil (Drug)
结局指标
主要结局
Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
时间窗: Twenty Eigth days
A subject is considered to abandon treatment if within 28 days * dies * Do not come to visit week 4 * changed or discontinued study treatment.
次要结局
- time to loss of adherence to TARV(twenty eight days)
- degree of adhesion during the treatment period(twenty eight days)
- Incidence of clinical adverse events and / or laboratory alterations.(twenty-four weeks)
- Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up(twenty four weeks)
- Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.(twenty four weeks)
研究者
Anna Cruceta
project manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (1)
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