PACTG P1026S PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS IN 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。这是一项前瞻性药代动力学研究，旨在评估目前处方的抗逆转录病毒药物以及这些药物相互作用的组合在hiv感染孕妇中的药代动力学。受试者可在妊娠60 ~ 26周时入组。受试者必须加入P1025，目前正在接受以下抗逆转录病毒药物之一或成人剂量的相互作用组合：奈韦拉平200mg b.b.d，安普雷那韦1200mg b.b.d，阿巴卡韦300mg bid。，洛匹那韦/利托那韦400/ 100mg b.i.d，或因地那韦/利托那韦800/ 100mg bid的超说明书剂量组合。在本方案中选择的药物/组合是在PACTG 367数据库中最常用的，缺乏妊娠期间药代动力学数据。接受每种药物或联合用药的25名孕妇将被纳入该方案，总共纳入125名妇女。参与该研究的孕妇将在妊娠晚期和产后6至12周期间进行密集的PK抽样。在PK取样当天，研究访问应安排在上午开始，并与上一个给药周期的结束时间一致。每位受试者将被采集血液样本，然后在诊所给予下一剂量的研究药物。受试者将留在诊所，直到研究日完成PK取样。

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. This is a prospective pharmacokinetic study to evaluate the pharmacokinetics of currently prescribed antiretroviral drugs and interacting combinations of these drugs in pregnant HIV-infected women. Subjects can enroll at >26 weeks gestation. Subjects must be enrolled in P1025 and currently receiving one of the following antiretroviral drugs or interacting combinations at adult dosing: nevirapine 200 mg b.i.d., amprenavir 1200 mg b.i.d., abacavir 300 mg bid.,lopinavir/ritonavir 400/100 mg b.i.d., or the off-label dosing combination of indinavir/ritonavir 800/100 mg bid. The drugs/combinations selected for study in this protocol were among those most commonly used in PACTG 367 database that lacked pharmacokinetic data during pregnancy. Twenty-five pregnant women receiving each drug or combination will be enrolled in the protocol, for a total enrollment of 125 women. Pregnant women participating in the study will have intensive PK sampling performed during the third trimester of pregnancy and again between 6 and 12 weeks postpartum. On the day of PK sampling, the study visit should be scheduled to start in the morning and to coincide with the end of the previous dosing cycle. Each subject will have a blood sample collected and then will be given the next dose of study medication in the clinic. Subjects will remain in the clinic until the completion of PK sampling on study days.