ANTIRETROVIRAL DRUGS DURING PREGNANCY, HIV INFECTED WOMEN (SUB OF PACTG P1025)

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项前瞻性药代动力学（PK）研究，旨在评价目前处方的抗逆转录病毒（ARV）药物及其相互作用组合在妊娠HIV感染女性中的药代动力学。受试者可以在>或等于妊娠26周时入组。受试者必须入组PACTG方案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组合：奈韦拉平200 mg b.i.d.，安普那韦1200 mg b.i.d.，阿巴卡韦300 mg b.i.d.，洛匹那韦/利托那韦400/100 mg b.i.d.，或indinavir/ritonavir 800/100 mg b.i.d. 研究目的是：主要：描述目前用于妊娠HIV感染女性临床护理的选定抗逆转录病毒药物在妊娠期间的PK参数，并确定这些抗逆转录病毒药物的治疗性给药方案是否在妊娠期间产生足够的药物暴露，与a）非妊娠成人的历史数据;和B）研究队列中相同女性在产后期间相比。 中学：1.比较分娩时脐带血和母体血浆中抗逆转录病毒药物的浓度。2.通过测定尿液中6 B-羟基皮质醇与皮质醇的比值，间接评估细胞色素P450 3A 4的诱导作用。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。在每个PK采样日，通过测量6 B-羟基皮质醇和皮质醇的尿液浓度，评价每例受试者的糖皮质激素代谢。受试者将在整个妊娠期间继续服用处方药物。

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 pharmacokinetics (PK) study to evaluate the pharmacokinetics of currently prescribed antiretroviral (ARV) drugs and interacting combinations of these drugs in pregnant HIV-infected women. Subjects can enroll at > or equal to 26 weeks gestation. Subjects must be enrolled in PACTG protocol 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 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. The study objectives are: PRIMARY: To describe the PK parameters during pregnancy of selected antiretroviral drugs currently used in the clinical care of pregnant HIV-infected women, and to determine if therapeutic dosing regimens of these antiretroviral drugs produce adequate drug exposure during pregnancy compared to a) historical data from non-pregnant adults; and b) the same women in the study cohorts during the postpartum period. SECONDARY: 1. To compare antiretroviral drug concentrations in plasma from cord blood with those in maternal plasma at the time of delivery. 2. To indirectly assess the induction of cytochrome P450 3A4 by determining the ratio in urine of 6B-hydroxycortisol to cortisol. 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. Glucocorticoid metabolism will be evaluated in each subject on each PK sampling day by measurement of urine concentrations of 6B-hydroxycortisol and cortisol. Subjects will continue to take their prescribed medications throughout the course of their pregnancy.