ARV Concentrations in Hair
关键词
抽象
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).
日期
| 最后验证: | 05/31/2018 |
| 首次提交: | 05/03/2016 |
| 提交的预估入学人数: | 05/08/2016 |
| 首次发布: | 05/10/2016 |
| 上次提交的更新: | 06/10/2018 |
| 最近更新发布: | 06/12/2018 |
| 实际学习开始日期: | 03/31/2016 |
| 预计主要完成日期: | 01/29/2017 |
| 预计完成日期: | 01/29/2017 |
状况或疾病
干预/治疗
Other: HIV negative and positive individuals
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| HIV negative and positive individuals 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. Hair analysis. | Other: HIV negative and positive individuals Within the laboratory, experimental factors controlling IR-MALDESI response to key ARVs representing various drug classes will be systematically evaluated using the design of experiments (DOE) statistical approach (41,127) for an unbiased optimization of IRMALDESI response to each of the ARVs and their major metabolites. The goal will be to achieve a lower limit of quantification (LLOQ) below clinically relevant hair strand concentrations. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - Subjects non-adherent to anti-retroviral regimen - Subjects not willing or able to provide head hair sample |
结果
主要结果指标
1. IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach [1 year]
2. IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with straighteners [1 year]
3. IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with hair color [1 year]
