CLINICAL TRIAL: PACTG P1025 PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 主要目标 描述目前用于HIV感染孕妇临床护理的部分抗逆转录病毒(ARV)药物在妊娠期的药代动力学(PK)参数，并确定这些抗逆转录病毒药物的标准治疗剂量方案在怀孕期间是否产生足够的药物暴露，与a)来自非怀孕成年人的历史数据和b)研究队列中相同的妇女在产后时期的比较。 次要目标 比较分娩时脐带血和母体血浆中抗逆转录病毒药物浓度。 通过测定尿液中6β羟基皮质醇与皮质醇的比值，间接评价细胞色素P450 3A4的诱导作用。目的：测定孕期和产后阿扎那韦、福沙普那韦、洛比那韦、奈非那韦和替普拉那韦的血浆蛋白结合率。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary Objectives To describe the pharmacokinetic (PK) parameters during pregnancy of selected antiretroviral (ARV) drugs currently used in the clinical care of pregnant HIV infected women, and to determine if standard therapeutic dosing regimens of these antiretroviral drugs produce adequate drug exposure during pregnancy compared to a) historical data from non-pregnant adults and b) the same women in the study cohorts during the post partum period. Secondary Objectives To compare antiretroviral drug concentrations in plasma from cord blood with those in maternal plasma at the time of delivery. To indirectly assess the induction of cytochrome P450 3A4 by determining the ratio in urine of 6 beta hydroxycortisol to cortisol. To determine plasma protein binding of atazanavir, fosamprenavir, lopinavir, nelfinavir and tipranavir during pregnancy and postpartum.