Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Iohexol clearance
研究概览
简要总结
Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.
详细描述
This cross-sectional sub-study will use a subset of the main study cohort of transgender (TG) or non-binary (NB) individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values (serum estradiol, estrone, free/total testosterone), renal biomarkers, drug levels (measured by tenofovir diphosphate, TFV-DP, and emtricitabine triphosphate, FTC-TP, on dried blood spot cards and urine) and directly measured renal function (iohexol clearance).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-uninfected
- •Identifying as transgender or nonbinary (TG/NB)
- •Age ≥ 18 years (adult)
- •At risk of acquiring HIV
- •Calculated creatinine clearance (CRCL) ≥ 60 mL/minute
- •Taking emtricitabine/tenofovir alafenamide
- •Willing to receive a small dose of iohexol
- •Willing to provide 30 mL blood and a urine sample
排除标准
- •Allergy to iohexol
- •Use of concurrent medications that may interfere with iohexol such as metformin, amiodarone or beta-blockers
- •Anuric or unable to produce 30 mL of urine
- •Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives
研究组 & 干预措施
Iohexol injection
The research pharmacist will prepare the iohexol injection in a 1cc tuberculin syringe, consisting of 0.5cc sterile water for injection (SWFI) and 0.5cc iohexol (Omnipaque 300). The study coordinator/personnel (licensed RN) will inject the iohexol dose into the subcutaneous tissue on the opposite arm used for blood sampling; the time will be recorded. The participant will be monitored for adverse events 30 minutes post iohexol administration at the AVRC. If the participant has not had any adverse event within 30 minutes, they will be asked to leave the AVRC and return within 2 hours and 55 minutes post Iohexol injection for lab collection.
干预措施: IHX-CL measurements (Diagnostic Test)
Iohexol injection
The research pharmacist will prepare the iohexol injection in a 1cc tuberculin syringe, consisting of 0.5cc sterile water for injection (SWFI) and 0.5cc iohexol (Omnipaque 300). The study coordinator/personnel (licensed RN) will inject the iohexol dose into the subcutaneous tissue on the opposite arm used for blood sampling; the time will be recorded. The participant will be monitored for adverse events 30 minutes post iohexol administration at the AVRC. If the participant has not had any adverse event within 30 minutes, they will be asked to leave the AVRC and return within 2 hours and 55 minutes post Iohexol injection for lab collection.
干预措施: Iohexol (Drug)
结局指标
主要结局
Iohexol clearance
时间窗: Day 1
Rate of clearance (mL/min) of iohexol from the body after a small dose is administered subcutaneously. Iohexol clearance is the gold standard for measuring kidney function.
次要结局
- Blood concentration of tenofovir(Day 1)
研究者
Nimish Patel
Assoc Prof Clinical
University of California, San Diego