PACTG P1026S: PK PROPERTIES OF ANTIRETROVIRAL DRUGS DURING PREGNANCY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。P1026S是一项针对感染艾滋病毒的孕妇的I期研究，作为临床护理的一部分，她们已经接受了奈韦拉平200毫克，氨丙那韦1200毫克，阿巴卡韦300毫克，洛匹那韦/利托那韦400/100毫克，或非标签剂量组合吲哚那韦/利托那韦800/100毫克，因为这些孕妇常用的重要药物组合缺乏PK数据。每种药物/药物组合的25名受试者或总共125名参与PACTG P1025的女性将被纳入这项前瞻性PK子研究。PK评估将在产前、产中和产后进行。如果发现药物水平不足，可能会进行剂量调整。这项研究将描述这些药物在怀孕期间的PK参数，并确定治疗剂量方案是否在怀孕期间产生足够的药物暴露。

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. P1026S is a phase I study of HIV-infected pregnant women who are already receiving, as part of their clinical care, nevirapine 200 mg b.i.d., amprenavir 1200 mg b.i.d., abacavir 300 mg b.i.d., lopinavir/ritonavir 400/100 mg b.i.d., or the off-label dosing combination of indinavir/ritonavir 800/100 mg b.i.d since these important and commonly used drug combinations in pregnant women lack PK data. 25 subjects per drug/drug combination or a total of 125 women participating in PACTG P1025 will be enrolled into this prospective PK substudy. PK evaluation will be performed antepartum, intrapartum, and postpartum. If drug levels are found to be inadequate, dose adjustments may be made. This study will describe PK parameters during pregnancy of these drugs and determine if therapeutic dosing regimens produce adequate drug exposure during pregnancy.