The Thai Red Cross AIDS Research Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Geometric mean (%CV) half-life (t1/2) of tenofovir
研究概览
简要总结
Objective
- To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW
- To evaluate ARV adherence among TGW
详细描述
GAHT will be initiated on week 0. ARVs, either PrEP or ART, will be initiated on week 3. GAHT will then be withheld on week 5, and restart at week 8.
GAHT: Oral estradiol valerate 2 mg once daily and cyproterone acetate 25 mg once daily, which are the treatment of choice for GAHT in the TRC-ARC's Tangerine Community Health Center, will be provided to all participants.
PrEP and ART regimen: Generic fixed-dose combination of TDF 300 mg and FTC 200 mg will be used for PrEP and a generic fixed-dose combination of TDF 300 mg, FTC 200 mg and efavirenz 600 mg will be used for ART as recommended in the 2017 Thailand National Guidelines on HIV/AIDS Treatment and Prevention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Thai nationality
- •Age 18-40 years old
- •Male-to-female transgender individual
- •PrEP/ART naïve
- •Body mass index 18.5-25 kg/m2
- •Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft- Gault equation
- •Alanine aminotransferase (ALT) ≤2.5 x ULN
- •Have signed the informed consent form
排除标准
- •Known history of allergy to hormonal or ARV component to be used in the study
- •Male-to-female transgender who underwent orchiectomy
- •Any of the following in HIV-infected participants
- •CD4 < 350 cells/mm3
- •History of psychiatric disorder that may be worsening by taking EFV
- •Previous use of injectable GAHT in the past 6 months
- •Current use of any of the following medication:
- •Anticonvulsant: Phenytoin, carbamazepine or phenobarbitol
- •Ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives
- •Sedatives: Midazolam or triazolam
- •Herbs: Gingko biloba, St John's wort or milk thistle
- •Anti-infective agents: Erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin
- •Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
结局指标
主要结局
Geometric mean (%CV) half-life (t1/2) of tenofovir
时间窗: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of tenofovir
时间窗: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of tenofovir
时间窗: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of estradiol
时间窗: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of tenofovir
时间窗: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) half-life (t1/2) of estradiol
时间窗: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of estradiol
时间窗: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of estradiol
时间窗: Measured at week 3 and week 5 of the study period
次要结局
未报告次要终点