PACTG P1026S: PK PROPERTIES OF ANTIRETROVIRAL DRUGS DURING PREGNANCY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。P1026S是一项针对感染hiv的孕妇的I期研究，作为其临床护理的一部分，这些孕妇已经接受奈韦拉平200毫克/天，安普雷那韦1200毫克/天，阿巴卡韦300毫克/天，洛匹那韦/利托那韦400/100毫克/天，或因地那韦/利托那韦800/100毫克/天的标签外剂量组合，因为这些重要和常用的药物组合在孕妇中缺乏PK数据。每个药物/药物组合25名受试者或参与PACTG P1025的125名女性将被纳入该前瞻性PK亚研究。PK评估将在产前、产时和产后进行。如果发现药物水平不足，可以进行剂量调整。本研究将描述这些药物在妊娠期间的PK参数，并确定治疗剂量方案是否在妊娠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.