DD-PrEP: Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Intracellular tenofovir-diphosphate concentrations (fmol/10^6)
研究概览
简要总结
The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.
详细描述
HIV prevention using oral pre-exposure prophylaxis (PrEP) with tenofovir-containing regimens is a promising strategy to reduce the incidence of HIV infection. The study participants will receive a double dose [2 tablets] of Descovy (tenofovir alafenamide [TAF] 25 mg/emtricitabine [FTC] 200mg; F/TAF) and be followed over the course of 14 days. Intensive pharmacokinetic (PK) will occur right after dose administration, and become sparser over the next 14 days. Understanding the PK of TAF, tenofovir (TFV), and FTC and the intracellular metabolites could be used to assess the protective and therapeutic plausibility of alternate, less frequent dosing regimens for PrEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •≥18 years of age, inclusive on the date of screening
- •Provides written informed consent for the study
- •Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests
- •Non-reactive HIV test results within four weeks of enrollment
- •An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation
- •Agrees to use condoms for all sexual events during study participation
- •Willing to abstain from oral PrEP use outside of study products for the duration of the study
排除标准
- •History of oral PrEP (F/TDF or F/TAF) use in the preceding two months
- •Persons who have a reactive or positive HIV result from screening visit.
- •Positive hepatitis B surface antigen (HBsAg) test
- •Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
- •History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks)
- •Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption
- •Pregnancy or lactation
- •Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
研究组 & 干预措施
F/TAF dosing
Received one-time dosing of two F/TAF tablets
干预措施: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg (Drug)
结局指标
主要结局
Intracellular tenofovir-diphosphate concentrations (fmol/10^6)
时间窗: 168 hours
次要结局
未报告次要终点