PACTG P1026S PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS IN PREGNANCY

PACTG P1026S 妊娠期抗逆转录病毒药物的药代动力学特性

• 批准号: 7603188
• 负责人: Robert Floyd Pass
• 金额: $ 0.72万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603188
• 关键词: Adult; Amprenavir; Anti-Retroviral Agents; Blood specimen; Clinic; Computer Retrieval of Information on Scientific Projects Database; Data; Databases; Dose; Drug Combinations; Drug Kinetics; Enrollment; Funding; Grant; Indinavir; Institution; Label; Lopinavir/Ritonavir; Nevirapine; Patient currently pregnant; Pharmaceutical Preparations; Postpartum Period; Pregnancy; Pregnant Women; Property; Protocols documentation; Research; Research Personnel; Resources; Ritonavir; Sampling; Sampling Studies; Schedule; Source; Third Pregnancy Trimester; United States National Institutes of Health; Visit; Week; Woman; abacavir; day; prospective

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 中心，不一定是研究者的机构。 这是一项前瞻性药代动力学研究，旨在评估当前处方抗逆转录病毒药物以及这些药物在艾滋病毒感染孕妇中的相互作用组合的药代动力学。受试者可以在妊娠 >26 周时入组。受试者必须参加 P1025，并且目前正在接受以下一种抗逆转录病毒药物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 bid.、洛匹那韦/利托那韦 400/100 mg b.i.d.，或关闭-标签剂量组合茚地那韦/利托那韦 800/100 mg bid。本方案中选择用于研究的药物/组合属于 PACTG 367 数据库中最常用的药物/组合，但缺乏妊娠期间的药代动力学数据。 接受每种药物或组合治疗的 25 名孕妇将被纳入该方案，总共 125 名女性。参与该研究的孕妇将在妊娠晚期以及产后 6 至 12 周期间进行密集 PK 采样。在 PK 采样当天，研究访问应安排在 早上并与上一个给药周期结束一致。每个受试者都会采集血样，然后在诊所接受下一剂研究药物。 受试者将留在诊所直至研究日完成 PK 采样。