Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 16
- 主要终点
- Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
研究概览
简要总结
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks
详细描述
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for four Weeks.
Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •an age above 18 years
- •consultation within 48 hours following a risk of HIV transmission (blood or sexual contact)
- •indication for HIV post-exposure prophylaxis (according to French guidelines)
- •person able to understand the nature of the study
- •person who signed his consent form to participate in the study
排除标准
- •person exposed to HIV risk from person infected by HIV, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs
- •contraindications to the prescription of Genvoy
- •other medical contraindications
- •person infected by hepatitis B virus
- •pregnant or lactating woman
研究组 & 干预措施
Genvoya
Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
干预措施: Genvoya (Drug)
结局指标
主要结局
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
时间窗: Day 28
次要结局
未报告次要终点