IGHID 11601 - Measuring Antiretroviral Concentrations in Hair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach
研究概览
简要总结
Hair samples from subjects on antiretroviral therapy, both HIV- and HIV+ patients with HIV RNA <50copies/mL for >6 months will be analyzed to investigate the influence of race, hair color and hair treatment on ARV response.
详细描述
A small thatch of hair (approximately 20 strands) will be collected from 85 participants who are currently taking antiretrovirals (ARVs). Hair collection will be evenly distributed into color cohorts: Black, Brown, Blonde and Grey. Participants will need to be >80% adherent to their medication and have had an undetectable HIV RNA VL within the previous 6 months. In the lab, samples will be used to develop IR-MALDESI MSI hair protocols for high sensitivity and accuracy to quantify ARVs in 5 therapeutic drug classes (Integrase Inhibitors, Nucleoside Reverse Transcriptase Inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitors, Entry Inhibitors, Protease Inhibitors).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Negative or HIV positive individuals, aged 18 years or older, who have been taking their ARV medication for at least 3 months and are adherent based on blood plasma HIV RNA of <50 copies/mL or HIV negative status.
排除标准
- •Subjects non-adherent to anti-retroviral regimen
- •Subjects not willing or able to provide head hair sample
结局指标
主要结局
IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach
时间窗: 1 year
The effect of bleaching on hair collected from subjects adherence to an ARV regimen for \>6 months
IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with straighteners
时间窗: 1 year
The effect of straighteners on hair collected from subjects adherent to an ARV regimen for \>6 months
IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with hair color
时间窗: 1 year
The effect of hair color (dye) on hair collected from subjects adherent to an ARV regimen for \>6 months
次要结局
未报告次要终点