CLINICAL TRIAL: PACTG P1025 PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 主要目标 描述目前用于妊娠HIV感染女性临床护理的选定抗逆转录病毒（ARV）药物在妊娠期间的药代动力学（PK）参数，并确定这些抗逆转录病毒药物的标准治疗给药方案是否在妊娠期间产生足够的药物暴露，与a）非妊娠成人的历史数据和B）研究队列中相同女性在产后期间的数据相比。 次要目的 比较分娩时脐带血和母体血浆中抗逆转录病毒药物的浓度。 通过测定尿液中6 β-羟基皮质醇与皮质醇的比值，间接评估细胞色素P450 3A 4的诱导作用。 测定妊娠期和产后阿扎那韦、福沙那韦、洛匹那韦、奈非那韦和替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.