Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 15
- 主要终点
- HIV-1 RNA in plasma (week 24)
研究概览
简要总结
The goal of this study is to analyze in treatment-naïve HIV patients the antiviral activity, using a test and treat strategy, in real life of BIC/FTC/TAF. Secondary, this study aims to evaluate outcomes for implementation of the evidence based test and treat strategy.
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
- •HIV-1 infected adults (>17 y.o.)
- •Antiretroviral-naïve.
- •Be able to comply with protocol requirements and instructions.
- •Subject or the subject's representative capable of giving signed informed consent
排除标准
- •Women who are breastfeeding or plan to become pregnant during the study.
- •Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
- •Patients with anticipated need to change the ART before study ending.
研究组 & 干预措施
study group
HIV-1 infected adults, ART-naive subjects, who start BIC/FTC/TAF using test and treat strategy recruited at infectious diseases units from various Spanish public healthcare centers.
干预措施: BIC/FTC/TAF (Drug)
结局指标
主要结局
HIV-1 RNA in plasma (week 24)
时间窗: 24 week
copies of HIV RNA -1 in plasma at week 24
HIV-1 RNA in plasma week 48
时间窗: 48 week
copies of HIV RNA -1 in plasma at week 48
次要结局
- Retention in care(48 week)
- Quality of Life patient reported outcomes EQ-5D(48 week)
- viral resistance(48 week)
- Feasibility of test and treat strategy(48 week)
- Medicaction adherence(48 week)
- antiviral activity(48 week)
- demographics and baseline characteristics(48 week)
- Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index(48 week)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](48 week)
研究者
Carmen Hidalgo Tenorio
Principal Investigator, Medical Director of the Early Stage Clinical Trial Unit-IBS.Granada
University Hospital Virgen de las Nieves