STUDY CLOSE-OUT FOR THE RANDOMIZED TRIAL TO EVALUATE THE VIROLOGIC RESPONSE AND PHARMACOKINETICS OF TWO DIFFERENT POTENT REGIMENS IN HIV INFECTED WOMEN

评估两种不同有效治疗方案对 HIV 感染女性的病毒学反应和药代动力学的随机试验研究收尾

• 批准号: 10460093
• 负责人: PARBARA DRIVER
• 金额: $ 5.23万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10460093
• 关键词: Anti-Retroviral Agents; Caring; Data; Data Analyses; Data Set; Data Store; Drug Kinetics; HIV; Integrase Inhibitors; Manuscripts; National Institute of Child Health and Human Development; Newborn Infant; Pharmacology; Pregnancy; Pregnant Women; Protocols documentation; Regimen; Reverse Transcriptase Inhibitors; Safety; Sampling; Woman; antiretroviral therapy; randomized trial; repository; response; risk minimization; transmission process; virology

To perform and complete the study close out of the protocol, which is to compare the safety, tolerance, virologic and pharmacologic responses of representatives of these two antiretroviral (ARV) classes in HIV-infected pregnant women presenting late for care. HIV-infected pregnant women presenting for care late in pregnancy need a rapid response and effective ARV therapy to minimize the risk of HIV transmission to their newborn. No data are available comparing the effects of non-nucleotide reverse transcriptase inhibitors (NNRTIs) and Integrase Inhibitors (IIs) in pregnant women. Completion of the close out activities of this protocol will provide the final dataset/information. The study close-out activities include the completion of the manuscript, complete data analysis and store data and samples to the NICHD DASH repository.

执行并完成方案中的研究结束，即比较这两种抗逆转录病毒（ARV）药物在晚到就诊的HIV感染孕妇中的安全性、耐受性、病毒学和药理学应答。感染艾滋病毒的孕妇在怀孕后期就诊时需要快速反应和有效的抗逆转录病毒治疗，以尽量减少艾滋病毒传染给新生儿的风险。没有数据比较非核苷酸逆转录酶抑制剂（NNRTI）和整合酶抑制剂（IIs）在孕妇中的作用。完成本方案的收尾活动将提供最终数据集/信息。研究结束活动包括完成手稿、完成数据分析并将数据和样本存储到NICHD DASH储存库。