PACTG P1026S PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS IN PREGNANCY

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来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 这是一项前瞻性药代动力学研究，旨在评价目前处方的抗逆转录病毒药物和这些药物相互作用的组合在妊娠HIV感染女性中的药代动力学。受试者可以在妊娠>26周时登记。受试者必须入组P1025，并且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复方制剂：奈韦拉平200 mg b.i.d.，安普那韦1200 mg b.i.d.，阿巴卡韦300 mg bid.，洛匹那韦/利托那韦400/100 mg b.i.d.，或indinavir/ritonavir 800/100 mg bid的标签外给药组合。本方案中选择用于研究的药物/联合用药是PACTG 367数据库中最常用的药物/联合用药，该数据库缺乏妊娠期间的药代动力学数据。 接受每种药物或联合治疗的25名妊娠女性将入组研究方案，总计入组125名女性。参与研究的妊娠女性将在妊娠晚期和产后6 - 12周期间进行密集PK采样。PK采样当天，研究访视应安排在 早晨，并与前一个给药周期结束时一致。将采集每例受试者的血液样本，然后在诊所接受下一次研究药物给药。 受试者将留在诊所，直至研究日完成PK采样。

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.