PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL THERAPY DURING PREGNANCY

妊娠期间抗逆转录病毒治疗的药代动力学特性

• 批准号: 7606170
• 负责人: MARGARET A KELLER
• 金额: $ 0.74万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606170
• 关键词: Amprenavir; Anti-Retroviral Agents; Back; Blood; Blood specimen; Caring; Clinic; Computer Retrieval of Information on Scientific Projects Database; Consent; Consultations; Dose; Drug Kinetics; Enrollment; Funding; Grant; HIV; Heparin; Indinavir; Institution; Laboratories; Lopinavir/Ritonavir; Measures; Medicine; Nevirapine; Patient currently pregnant; Patients; Perinatal; Pharmaceutical Preparations; Placenta; Pregnancy; Pregnant Women; Property; Protocols documentation; Purpose; Reporting; Research; Research Personnel; Resources; Risk; Ritonavir; Sampling; Site; Source; Standards of Weights and Measures; Testing; Time; Umbilical cord structure; United States National Institutes of Health; Upper arm; Visit; Week; Woman; abacavir; antiretroviral therapy; day

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 substudy of P1025 "Perinatal Core Protocol" study and will enroll a total of 125 women, about 4-5 at this site. The purpose of this study is to find the appropriate dose of selected antiretroviral medications for pregnant women as compared to women who are not pregnant. Women who are taking the following antiretroviral medications: Nevirapine 200 mg 2 times a day, Indinavir/Ritonavir 800/100 mg 2 times a day, Kaletra 400/100 mg 2 times a day, Amprenavir 1200 mg 2 times a day, Abacavir 300 mg 2 times a day, will be included in this study. The patient will be seen two times at the GCRC, once during the last three months of pregnancy and again at 6-12 weeks after delivery, for pharmacokinetics. At each visit, a heparin lock will be placed in the patient's arm and at least five, but no more than eight sample (1-2 teaspoons) of blood will be drawn, depending on the medicines the patient is taking. The total amount of blood that will be drawn at each visit will be about 6-9 teaspoons. At the time of delivery, about two teaspoons of blood will be drawn for routine laboratory tests and to measure the amount of aniretroviral medicine in the patient's blood. A blood sample, about two teaspoons, will also be drawn from the umbilical cord that is attached to the placenta. These samples will be in addition to what will be drawn in P1025. The level of HIV antiretroviral medications will be reported back to the patient and her doctor as soon as possible to help decide, in consultation with the patient's doctors, to increase the amount of medicines. The patient has an option of having the amount of medicine measured in the new dose. The benefit of this substudy is to find the correct amount (dose) of antiretroviral medications in pregnancy which will not be done as a standard of care. The risks are associated with blood drawing and the need to be admitted to GCRC for a day (two times) for the pharmacokinetics. Consent will be obtained in the OB clinic during one of the patient's visits.

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。 这是P1025“围产期核心方案”研究的一项子研究，将共入组125名女性，该研究中心约4-5名。本研究的目的是与未怀孕的女性相比，找到适合孕妇的选定抗逆转录病毒药物的适当剂量。正在服用以下抗逆转录病毒药物的女性：奈韦拉平200 mg每日2次、茚地那韦/利托那韦800/100 mg每日2次、Kaletra 400/100 mg每日2次、安普那韦1200 mg每日2次、阿巴卡韦300 mg每日2次，将被纳入本研究。患者将在GCRC接受两次药代动力学检查，一次在妊娠最后3个月，另一次在分娩后6-12周。每次访视时，将在患者手臂上放置肝素锁，根据患者正在服用的药物，将抽取至少五份但不超过八份血液样本（1-2茶匙）。每次访视时抽取的血液总量约为6-9茶匙。在分娩时，将抽取大约两茶匙的血液进行常规实验室检查，并测量患者血液中抗逆转录病毒药物的含量。血液样本，约两茶匙，也将从脐带是连接到胎盘。这些样本将作为P1025中抽取样本的补充。艾滋病毒抗逆转录病毒药物的数量将尽快报告给病人及其医生，以便与病人的医生协商，帮助决定增加药物的数量。患者可以选择在新剂量中测量药物的量。这项子研究的好处是找到正确的量（剂量）的抗逆转录病毒药物在怀孕，这将不会作为一个标准的护理。风险与抽血和需要进入GCRC一天（两次）进行药代动力学研究有关。将在患者的一次访视期间在OB诊所获得知情同意。