PACTG P1026S: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUG DURING PREGNANCY

PACTG P1026S：妊娠期间抗逆转录病毒药物的药代动力学特性

• 批准号: 7605082
• 负责人: Elizabeth Jane McFarland
• 金额: $ 4.49万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/7605082
• 关键词: Adult; Anti-Retroviral Agents; Atazanavir; Blood specimen; Computer Retrieval of Information on Scientific Projects Database; Didanosine; Dose; Drug Combinations; Drug Kinetics; Enrollment; Evaluation; Funding; Grant; Institution; Lopinavir/Ritonavir; Pharmaceutical Preparations; Population; Postpartum Period; Pregnancy; Pregnant Women; Property; Research; Research Personnel; Resources; Ritonavir; Sample Size; Sampling; Source; Tenofovir; Third Pregnancy Trimester; Time; Treatment Protocols; United States Food and Drug Administration; United States National Institutes of Health; Week; Weight; abacavir; design; emtricitabine; fosamprenavir; intrapartum; peripheral blood; 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. DESIGN: Prospective pharmacokinetic substudy for subjects enrolled in PACTG P1025 SAMPLE SIZE: The sample size will be 25 subjects per drug/drug combination or a total of 125 subjects. POPULATION: Subjects can enroll at = 20 weeks gestation. Subjects must be enrolled in P1025 and currently receiving one of the following antiretroviral drugs or interacting combinations at adult dosing: " abacavir (300 mg b.i.d.) " lopinavir/ritonavir (Kaletra¿) (400/100 mg b.i.d. until 30 weeks gestation, then 533/133 mg b.i.d. until results of postpartum PK evaluation are available) " fosamprenavir/ritonavir (700/100 mg b.i.d.) " atazanavir/ritonavir (300/100 mg q.d.) " ddI delayed release (Videx¿ EC) (400 mg q.d. if weight > 60 kg; 250 mg q.d. if weight < 60 kg) " emtricitabine (200 mg q.d.) " tenofovir (300 mg q.d.) " tenofovir/atazanavir/ritonavir (300/300/100 mg q.d.) REGIMEN: Pregnant women will continue on antiretroviral medications prescribed by their clinicians. Pharmacokinetic evaluations: Antepartum: peripheral blood specimen during third trimester (30-36 weeks); time of sampling will vary by antiretroviral regimen. Intrapartum: maternal peripheral blood specimen at time cord is clamped and cord blood specimen. Postpartum: peripheral blood specimen at 6-12 weeks postpartum; time of sampling will vary by antiretroviral regimen. Note: If it is found that drug levels are not adequate, dose adjustments may be made. The new dose may be higher than the current FDA approved dose.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 设计：纳入受试者的前瞻性药物动力学亚研究 PACTG P1025 样本量：每个药物/药物组合的样本量为25名受试者，或总计125名受试者。 人口：受试者可以在妊娠=20周时登记。受试者必须参加P1025，并且目前在成人剂量下接受以下抗逆转录病毒药物或相互作用的组合之一： 阿巴卡韦(300 mg，b.i.d) “Lopinavir/ritonavir(Kaletra？)(400/100 mg b.i.d直到妊娠30周，然后533/133 mg b.i.d直到产后PK评估结果出来) “福沙普利那韦/利托那韦(700/100 mg b.i.d)” “阿扎那韦/利托那韦(300/100 mg q.d.) “DDI延迟释放(视频)(400 mg q.d，如果重量为60 kg；250 mg q.d，如果重量为60 kg) “恩曲他滨(200 mg qd.) 替诺福韦(300 mg q.d.) “替诺福韦/阿扎那韦/利托那韦(300/300/100 mg q.d)” 治疗方案：孕妇将继续服用临床医生开出的抗逆转录病毒药物。 药代动力学评价： 产前：妊娠晚期(30-36周)的外周血样；取样时间因抗逆转录病毒疗法而异。 分娩时：母体外周血标本脐带夹闭和脐带血标本。 产后：产后6-12周的外周血标本；采样时间因抗逆转录病毒方案的不同而异。 注：如果发现药物水平不足，可能会进行剂量调整。新的剂量可能高于目前FDA批准的剂量。