PACTG P1026S: PK PROPERTIES OF ANTIRETROVIRAL DRUGS DURING PREGNANCY

PACTG P1026S：妊娠期间抗逆转录病毒药物的 PK 特性

• 批准号: 7379345
• 负责人: JANE E HITTI
• 金额: $ 0.92万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379345
• 关键词: PACTG; P1026S; PK; PROPERTIES; ANTIRETROVIRAL

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. P1026S is a phase I study of HIV-infected pregnant women who are already receiving, as part of their clinical care, 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 since these important and commonly used drug combinations in pregnant women lack PK data. 25 subjects per drug/drug combination or a total of 125 women participating in PACTG P1025 will be enrolled into this prospective PK substudy. PK evaluation will be performed antepartum, intrapartum, and postpartum. If drug levels are found to be inadequate, dose adjustments may be made. This study will describe PK parameters during pregnancy of these drugs and determine if therapeutic dosing regimens produce adequate drug exposure during pregnancy.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。 P1026S 是一项针对 HIV 感染孕妇的 I 期研究，作为临床护理的一部分，这些孕妇已经接受奈韦拉平 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. 或超说明书剂量组合 茚地那韦/利托那韦 800/100 mg b.i.d，因为这些重要且常用的孕妇药物组合缺乏 PK 数据。每种药物/药物组合有 25 名受试者或总共 125 名参与 PACTG P1025 的女性将被纳入这项前瞻性 PK 亚研究。 PK评估将在产前、产中和产后进行。如果发现药物水平不足，可以调整剂量。这项研究将描述这些药物在怀孕期间的 PK 参数，并确定治疗剂量方案是否在怀孕期间产生足够的药物暴露。