Institute of HIV Research and Innovation (IHRI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in plasma estradiol levels
研究概览
简要总结
Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among transgender women (TGW). New strategies for PrEP among TGW who use FHT are urgently needed. Because tenofovir alafenamide (TAF) can achieve higher intracellular TFV-DP levels with lower tenofovir plasma concentrations, it is promising that both plasma TFV and intracellular TFV-DP levels might not be significantly affected by FHT. The current study aims to determine the pharmacokinetics DDI between FHT and F/TAF-based PrEP among TGW.
详细描述
Two full pharmacokinetic (PK) measurements will be performed. Samples collected will include: plasma for estradiol (E2), emtricitabine (FTC), tenofovir (TFV), and tenofovir alafenamide (TAF) measurement; and peripheral blood mononuclear cells (PBMC) for emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) intracellular quantification.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Thai nationality
- •Age 18-40 years old
- •Transgender women
- •HIV-negative
- •Body mass index 18.5-24.9 kg/m2
- •Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft-Gault equation
- •Alanine aminotransferase (ALT) ≤2.5 x ULN
- •Signed the informed consent form
排除标准
- •Known history of allergy to hormonal component to be used in the study
- •Male-to-female transgender who underwent orchiectomy
- •Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
- •Use of injectable FHT in the past 3 months
- •Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen (HBsAg) positive
- •Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive
- •Current use of any of the following:
- •Anticonvulsants: carbamazepine, felbamate, oxcarbazepine, phenytoin, phenobarbital, primidone or topiramate
- •Herbs: gingko biloba, St John's wort or milk thistle
- •Anti-infective agents: azole antifungals, macrolides, griseofulvin, protease inhibitors, rifampicin or rifabutin
- •Participant-reported active rectal infection requiring treatment
- •History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
- •Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
研究组 & 干预措施
20 HIV-negative TGW
A single-arm prospective PK study of HIV-negative TGW taking FHT and daily PrEP.
干预措施: Estradiol valerate 2 mg, cyproterone acetate 25 mg (Drug)
结局指标
主要结局
Changes in plasma estradiol levels
时间窗: Measured at week 3 and week 9 of the study period
Changes in plasma PrEP levels
时间窗: Week 9 through 12
1. Plasma TFV 2. Plasma FTC 3. Plasma TAF
Changes in intracellular PrEP levels
时间窗: Week 9 through 12
1. PBMC TFV-DP levels 2. PBMC FTC-TP levels
次要结局
- Changes in plasma testosterone levels(Week 3 through 9)