Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Breastmilk to maternal plasma ratio
研究概览
简要总结
This is a prospective, multi-center, longitudinal, mother-infant pair, therapeutic drug monitoring study. The aim of this study is to determine concentrations of antiretroviral drugs in plasma and breastmilk in people living with HIV who chose to breastfeed while using antiretrovirals. At a planned hospital visit an extra maternal blood sample (1 to 2 per visit) and extra infant blood sample (1 per visit) will be collected, as well as a breastmilk sample (1 to 2 per visit). Ideally, sample collection will take place at least during the 1, 3 and 6 month post partum follow up visit. Measured concentrations will be used to calculate milk to plasma ratios, relative and absolute infant dosages.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •No exclusion criteria will be used at the screening for the trial.
结局指标
主要结局
Breastmilk to maternal plasma ratio
时间窗: 6 months post partum
Total concentration of antiretrovirals in breastmilk and plasma of the mother at a single time point to determine milk to plasma ratio.
次要结局
- Absolute infant dose(6 months post partum)
- Relative infant dose(6 months post partum)
- Comparison of absolute infant dose to approved pediatric dose(6 months post partum)
- Viral load in breastmilk(6 months post partum)