Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acceptance of immediate ART initiation
研究概览
简要总结
An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms
详细描述
Individuals with suspected acute HIV infection willing to start immediate ART treatment will be given the ART regimen (bictegravir 50mg + tenofovir alafenamide 25 mg + emtricitabine 200 mg fixed dose combination) on the day of diagnosis. Those patients beginning immediate ART in the ED who are willing to have additional laboratory specimens drawn in the ED and become part of a cohort to receive ART and have ongoing biological specimens obtained and will be followed for 48 weeks.
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
- •Suspected acute HIV infection
- •agree to start immediate ART and to storage of laboratory specimens
排除标准
- •Known chronic HIV infection
- •severe renal or liver disease
- •drug allergy/hypersensitivity
- •prohibited medications
- •pregnancy
- •co-morbidity that the investigator feels would compromise safety, data interpretation, or achieving study objectives
研究组 & 干预措施
Biktarvy
All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study
干预措施: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg (Drug)
结局指标
主要结局
Acceptance of immediate ART initiation
时间窗: 1 day
Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV
次要结局
- ART effects inflammation(48 weeks)
- ART effects monocyte activation(48 weeks)
- ART effects on cell associated HIV DNA(48 weeks)
- ART effects leukocytes(48 weeks)
- Impact on linkage and engagement in care(48 weeks)
研究者
Michael Dube
Professor of Medicine
University of Southern California