CLINICAL TRIAL: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS DURING PREGNA

临床试验：妊娠期间抗逆转录病毒药物的药代动力学特性

• 批准号: 8167068
• 负责人: Yvonne J. Bryson
• 金额: $ 0.15万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167068
• 关键词: Adult; Anti-Retroviral Agents; Clinical Trials; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Cytochrome P450 3A4; Data; Dose; Drug Exposure; Drug Kinetics; Funding; Grant; Hydrocortisone; Institution; Pharmaceutical Preparations; Plasma; Postpartum Period; Pregnancy; Property; Regimen; Research; Research Personnel; Resources; Source; Therapeutic; Time; Umbilical Cord Blood; United States National Institutes of Health; Urine; Woman; clinical care; pregnant

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. SPECIFIC AIMS: PRIMARY: To describe the PK parameters during pregnancy of selected antiretroviral drugs currently used in the clinical care of pregnant HIV-infected women, and to determine if standard therapeutic dosing regimens of these antiretroviral drugs produce adequate drug exposure during pregnancy compared to a) historical data from non-pregnant adults; and b) the same women in the study cohorts during the postpartum period. SECONDARY: To compare antiretroviral drug concentrations in plasma from cord blood with those in maternal plasma at the time of delivery. To indirectly assess the induction of cytochrome P450 3A4 by determining the ratio in urine of 6b-hydroxycortisol to cortisol.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 具体目标： 主要：描述目前用于妊娠HIV感染女性临床护理的选定抗逆转录病毒药物在妊娠期间的PK参数，并确定这些抗逆转录病毒药物的标准治疗给药方案是否在妊娠期间产生足够的药物暴露，与a）非妊娠成人的历史数据;和B）研究队列中相同女性在产后期间的药物暴露进行比较。 次要目的：比较分娩时脐带血血浆与母体血浆中的抗逆转录病毒药物浓度。 通过测定尿液中6 b-羟基皮质醇与皮质醇的比值，间接评估细胞色素P450 3A 4的诱导作用。