PACTG P1026S PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS IN PREGNANCY

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。 这是一项前瞻性的药代动力学研究，旨在评估目前处方的抗逆转录病毒药物以及这些药物在感染艾滋病毒的怀孕妇女中的相互作用组合的药代动力学。受试者可以在怀孕26周时报名。受试者必须在P1025中登记，目前在成人剂量下接受以下抗逆转录病毒药物或相互作用的组合之一：奈韦拉平200毫克，每日2次，氨丙那韦1200毫克，每日2次，阿巴卡韦300毫克，洛比那韦/利托那韦400/100毫克，每日2次，或非标签剂量的吲地那韦/利托那韦800/100毫克，每日2次。在该方案中选择用于研究的药物/组合是PACTG 367数据库中最常用的药物之一，这些药物/组合在怀孕期间缺乏药代动力学数据。 接受每种药物或联合药物治疗的25名孕妇将被纳入该方案，总共有125名妇女参加。参与这项研究的孕妇将在怀孕第三个月和产后6至12周之间进行密集的PK采样。在PK抽样当天，学习访问应安排在#年开始 上午，并与前一个给药周期结束时一致。每个受试者都将采集血样，然后在临床上给予下一剂量的研究药物。受试者将留在诊所，直到在学习日完成PK抽样。

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.