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.

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。 具体目的： 主要：描述当前用于孕妇感染HIV妇女临床护理的选定抗逆转录病毒药物的PK参数，并确定这些抗逆转录病毒药物的标准治疗药物治疗方案是否与非孕妇的A）历史数据相比，在怀孕期间产生充分的药物暴露； b）研究期间研究中的同一妇女。 次要：将脐带血中血浆中血浆中的抗逆转录病毒药物浓度与送达时血浆中的抗逆转录病毒药物浓度进行比较。 通过确定6b-羟基甲状溶胶与皮质醇的尿液的比例间接评估细胞色素P450 3A4的诱导。