A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- nPEP Failure
研究概览
简要总结
Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)
详细描述
Non-randomized, open label single arm trial conducted at Fenway Health as a single site. 100 subjects will be enrolled following a high risk sexual exposure in which HIV exposure is a concern. Each person will be provided with detailed informed consent and if they agree, will receive a 28 day regimen of BIC/F/TAF (Biktary) in a single fixed-dose tablet. Subjects will be seen for 3 visits over a period of four months in which assessments will be done to evaluate safety of product, tolerability of product and HIV status. All subjects will be compared to historical controls in the previous one daily TDF-based nPEP studies which were conducted at Fenway Health.
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
- 是
入选标准
- •> Age of 18 at time of first visit.
- •HIV uninfected
- •Willing and able to provide written informed consent.
- •Willing and able to provide adequate locator information.
- •Willing and able to return to all study visits.
- •Willing to participate in all study procedures.
- •Childbearing age: Willing to use contraception for as long as they are on study medication plus 7 days after. (Appendix A: list of approved contraception).
- •Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. A possible exposure could include:
- •Condomless anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage); or
- •Condomless penile exposure to cervicovaginal secretions or anorectal secretions from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage)
排除标准
- •An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
- •Pregnancy and/or breastfeeding.
- •People who are actively trying to become pregnant.
- •Acute or chronic hepatitis B infection.
- •Acute or chronic renal disease.
- •Creatinine clearance at or below 30 mL/min (Cockcroft-Gault0 Known intolerance or allergy to tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, or bictegravir.
- •Currently taking or plans to take prohibited medication while enrolled in the study. (Appendix B: complete list of prohibited medications).
- •Non-English speakers.
研究组 & 干预措施
Open Label Biktarvy
Single arm all participants receive open label study product intervention.
干预措施: bictegravir (Drug)
结局指标
主要结局
nPEP Failure
时间窗: 4 months active study participation
HIV sero-conversion during study participation following high risk exposure that occured within 72 hours of study product initiation.
Safety and Tolerability assessed as Adverse Events and Safety Lab Evaluation
时间窗: 4 months active study participation
The following AEs will be evaluated: Diarrhea, Fatigue, Nausea/Vomiting, Headache, Dizziness, Body/Muscle/Joint pain
次要结局
- Adherence and Acceptability assessed as study product completion rate(4 months of active study participation or 28 days of study product use)
研究者
Kenneth H. Mayer, MD
Medical Research Director, Co-Chair TFI
Fenway Community Health