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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项前瞻性药代动力学研究，旨在评估当前处方的抗逆转录病毒药物的药代动力学以及这些药物在怀孕的HIV感染妇女中的相互作用组合。受试者可以在妊娠> 26周内注册。受试者必须在P1025中注册，目前接受以下抗逆转录病毒药物之一或成人剂量时的相互作用组合：Nevirapine 200 mg B.I.D.，Amprenavir 1200 mg B.I.D.，Abacavir 300毫克bid。 Indinavir/Ritonavir 800/100毫克竞标。在该方案中选择进行研究的药物/组合是PACTG 367数据库中最常用的药物/组合，该数据库在怀孕期间缺乏药代动力学数据。 接受每种药物或组合的25名孕妇将纳入该方案，总招募125名妇女。参加这项研究的孕妇将在怀孕的第三个月和产后6到12周之间进行大量的PK采样。在PK抽样的那天，应安排学习访问开始 早晨，与先前的给药周期结束。每个受试者将收集一个血液样本，然后在诊所中给予下一次剂量的研究药物。 受试者将保留在诊所中，直到在研究日内完成PK采样。