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

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（PK）研究，旨在评估目前处方的抗逆转录病毒（ARV）药物和这些药物的相互作用组合在hiv感染孕妇中的药代动力学。受试者可在妊娠60周或等于妊娠26周时入组。受试者必须参加PACTG方案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.d，安普雷那韦1200mg b.d，阿巴卡韦300mg b.d，洛匹那韦/利托那韦400/ 100mg b.d，或茚那韦/利托那韦800/ 100mg b.d。研究目的是：描述目前用于艾滋病毒感染孕妇临床护理的抗逆转录病毒药物在怀孕期间的PK参数，并确定这些抗逆转录病毒药物的治疗剂量方案是否在怀孕期间产生足够的药物暴露与a)来自非怀孕成年人的历史数据；b)研究队列中同样的女性在产后时期。二级:1。比较脐带血血浆中抗逆转录病毒药物浓度与分娩时母体血浆中的浓度。2. 通过测定尿中6b -羟基皮质醇与皮质醇的比值，间接评估细胞色素P450 3A4的诱导作用。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。在每个PK采样日，通过测量尿液中6b -羟基皮质醇和皮质醇的浓度来评估每个受试者的糖皮质激素代谢。受试者将在整个怀孕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.