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.

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。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 中心，不一定是研究者的机构。 设计：对纳入受试者的前瞻性药代动力学亚研究 PACTG P1025 样本量：每种药物/药物组合的样本量为 25 名受试者，或总共 125 名受试者。 人群：受试者可以在妊娠 20 周时入组。受试者必须在 P1025 中入组，并且目前正在接受成人剂量的以下抗逆转录病毒药物之一或相互作用的组合： “阿巴卡韦（300 毫克，每日两次） 洛匹那韦/利托那韦 (Kaletra¿)（400/100 mg b.i.d.，直至妊娠 30 周，然后 533/133 mg b.i.d.，直至获得产后 PK 评估结果） “福沙那韦/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 (Videx¿ EC)（如果体重 > 60 kg，则每日 400 mg；如果体重 < 60 kg，则每日 250 mg） “恩曲他滨（200 mg q.d.） “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：孕妇将继续服用上级规定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）的外周血样本；采样时间因抗逆转录病毒治疗方案而异。 产时：脐带被夹住时的母亲外周血标本和脐带血标本。 产后：产后6-12周的外周血样本；采样时间因抗逆转录病毒治疗方案而异。 注意：如果发现药物水平不够，则可能会进行剂量调整，新剂量可能高于当前 FDA 批准的剂量。