NCT04233372已完成4 期
Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 2
- 主要终点
- Proportion of Participants Who Did Not Complete the 28-day PEP Regimen
研究概览
简要总结
Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects attending emergency room due to potential HIV exposition of either sex:
- •Aged 18 years or more.
- •Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs.
- •Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
- •Individuals able to do follow up correctly.
排除标准
- •Pregnant women or nursing mothers or women trying to conceive during the study period.
- •Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens.
- •Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
- •Allergic reactions or intolerance to the compounds of the study treatment regiments
研究组 & 干预措施
Delstrigo
Experimental
干预措施: Delstrigo (Drug)
结局指标
主要结局
Proportion of Participants Who Did Not Complete the 28-day PEP Regimen
时间窗: 28 days
Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion is considered in cases: 1. If the subject dies. 2. Does not go to visits (loss of follow-up) 3. Change or suspend the treatment under study for any reason. 4. Consent withdrawal
次要结局
- Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF(28 days)
- Assess the Baseline Characteristics Associated to Treatment Non-completion.(28 days)
- Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF(28 days)
- Adherence to cART During 28-day PEP Regimen(Day 0 to Day 28 (Week 4))
- Proportion of Subjects That Maintain Follow-up(Month 4)
- Rate of HIV Seroconversion(Day 0 to Day 84)
研究者
研究点 (2)
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