ANTIRETROVIRAL DRUGS DURING PREGNANCY, SUBSTUDY OF PACTG P1025

妊娠期间的抗逆转录病毒药物，PACTG P1025 的子研究

• 批准号: 7606233
• 负责人: MARK H MIROCHNICK
• 金额: $ 0.22万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606233
• 关键词: Adult; Amprenavir; Anti-Retroviral Agents; Caring; Clinical; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Cytochrome P450 3A4; Data; Dose; Drug Combinations; Drug Exposure; Drug Kinetics; Enrollment; Funding; Glucocorticoids; Grant; Hydrocortisone; Indinavir; Institution; Label; Lopinavir/Ritonavir; Measurement; Metabolism; Nevirapine; Patient currently pregnant; Pharmaceutical Preparations; Plasma; Postpartum Period; Pregnancy; Pregnant Women; Protocols documentation; Research; Research Personnel; Resources; Ritonavir; Sampling; Source; Therapeutic; Third Pregnancy Trimester; Time; Treatment Protocols; Umbilical Cord Blood; United States National Institutes of Health; Urine; 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 pharmacokinetics (PK) study to evaluate the pharmacokinetics of currently prescribed antiretroviral (ARV) drugs and interacting combinations of these drugs in pregnant HIV-infected women. Subjects can enroll at or equal to 26 weeks gestation. Subjects must be enrolled in PACTG protocol 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 b.i.d., lopinavir/ritonavir 400/100 mg b.i.d., or the off-label dosing combination of indinavir/ritonavir 800/100 mg b.i.d. The study objectives are: -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 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. -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. 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. Glucocorticoid metabolism will be evaluated in each subject on each PK sampling day by measurement of urine concentrations of 6B-hydroxycortisol and cortisol. Subjects will continue to take their prescribed medications throughout their pregnancy.

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。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项前瞻性药代动力学 (PK) 研究，旨在评估当前处方的抗逆转录病毒 (ARV) 药物以及这些药物在 HIV 感染孕妇中的相互作用组合的药代动力学。受试者可以在妊娠 26 周或等于 26 周时入组。受试者必须参加 PACTG 方案 P1025，并且目前正在接受以下一种抗逆转录病毒药物或成人剂量的相互作用组合：奈韦拉平 200 mg b.i.d.、安普那韦 1200 mg b.i.d.、阿巴卡韦 300 mg b.i.d.、洛匹那韦/利托那韦 400/100 mg b.i.d.，或标签外茚地那韦/利托那韦 800/100 mg b.i.d. 的给药组合 研究目标是： - 描述目前用于 HIV 感染孕妇临床护理的选定抗逆转录病毒药物在怀孕期间的 PK 参数，并确定这些抗逆转录病毒药物的治疗剂量方案是否在怀孕期间产生足够的药物暴露，与 a) 历史数据相比- 怀孕的成年人； b) 产后期研究队列中的相同女性。 -比较脐带血血浆中的抗逆转录病毒药物浓度与分娩时母体血浆中的抗逆转录病毒药物浓度。 -通过测定尿液中6B-羟基皮质醇与皮质醇的比率来间接评估细胞色素P450 3A4的诱导。 参与该研究的孕妇将在妊娠晚期以及产后 6 至 12 周期间进行密集 PK 采样。将在每个 PK 采样日通过测量 6B-羟基皮质醇和皮质醇的尿液浓度来评估每个受试者的糖皮质激素代谢。受试者在整个怀孕期间将继续服用处方药物。