International Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network

国际孕产妇、青少年和儿科治疗临床试验网络

• 批准号: 9986166
• 负责人: Grace M Aldrovandi
• 金额: $ 354.89万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9986166
• 关键词: Address; Adolescent; Affect; Anti-Retroviral Agents; Area; Biological Assay; Blood Volume; Caring; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Collaborations; Consultations; Development; Diagnosis; Disease remission; Drug resistance; Ensure; Epidemic; Evaluation; Formulation; Genetic; Goals; Guidelines; HIV; HIV/TB; Immune response; Infant; Infection; Infrastructure; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Interruption; Intervention; Knowledge; Label; Laboratories; Laboratory Research; Laboratory Study; Leadership; Licensure; Measurement; Methodology; Monitor; Multi-Drug Resistance; Pathogenesis; Pharmacology; Populations at Risk; Pregnant Women; Prevention; Reproducibility; Research; Research Personnel; Research Priority; Resources; Specimen; Technology; Testing; Therapeutic Clinical Trial; Total Quality Management; Training Programs; Tuberculosis; United States National Institutes of Health; Vertical Disease Transmission; Viral Load result; Vision; Vulnerable Populations; Work; antiretroviral therapy; assay development; base; clinical care; co-infection; comorbidity; data management; design; high standard; improved; innovation; interest; laboratory experience; laboratory experiment; novel; novel strategies; operation; programs; reconstruction; stem; study population; success; transmission process

ABSTRACT The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network has significantly advanced efforts to stem the global HIV epidemic among pregnant women, infants, children and adolescents through the conduct of high-quality clinical trials. The IMPAACT vision and overall goal is to end the worldwide HIV epidemic among these vulnerable populations. To achieve this goal, IMPAACT will evaluate novel and durable treatments for both HIV and TB, to establish strategies for antiretroviral treatment (ART)-free remission, and to address the complications, co-morbidities, and co-infections affecting these HIV-infected and at-risk populations of interest. The results of our studies have contributed to licensure or labeling changes for new antiretrovirals/formulations for use in HIV-infected pregnant women, infants and children and influenced international and US guidelines for clinical care in these vulnerable populations. In addition to generating concrete evidence in these areas, IMPAACT's work has served to build much needed research and laboratory capacity in resource-limited settings, where burden of the HIV epidemic remains the greatest. The IMPAACT Laboratory Center has been integral to the Network's success in defining the standards of care for HIV infected pregnant women, children and adolescents. Many of the mechanistic underpinnings that explain the success of IMPAACT clinical trials are managed and discovered by IMPAACT Laboratory Center investigators. In this competitive renewal of the IMPAACT Laboratory Center, we propose a work closely the Operations Center and the Statistical and Data Management Center to develop, implement and evaluate the laboratory activities necessary to accomplish IMPAACT's research agenda. Further, the Laboratory Center will ensure that there are relevant state-of-the-art expertise and technologies and to oversee all laboratory operations confirming that all laboratory results are consistent, reproducible and can support study reconstruction.

抽象的 国际孕产妇青少年艾滋病临床试验（Impaact）网络已显着 在孕妇，婴儿，儿童和青少年中阻止全球艾滋病毒流行的高级努力 通过进行高质量的临床试验。无情的愿景和整体目标是结束全球 这些脆弱人群中的艾滋病毒流行。为了实现这一目标，Impaact将评估小说和 艾滋病毒和结核病的耐用处理，以建立抗逆转录病毒治疗策略（ART） 缓解，并解决影响这些HIV感染的并发症和共同感染的 感兴趣的高危人群。我们的研究结果有助于许可或标签更改 用于HIV感染的孕妇，婴儿和儿童的新型抗逆转录病毒/配方，并受到影响 这些脆弱人群中的国际和美国临床护理指南。除了生成 在这些领域的具体证据，Impaact的工作已经建立了急需的研究和实验室 在资源有限的环境中，艾滋病毒流行负担仍然是最大的能力。不可能的 实验室中心一直是该网络成功定义艾滋病毒感染的护理标准不可或缺的一部分 孕妇，儿童和青少年。许多机械基础，解释了成功的成功 不可行的临床试验是由Inbaact Laboratoral Center研究人员管理和发现的。在这个 竞争性更新的竞争性实验室中心，我们紧密地提出了一项操作中心的工作， 统计和数据管理中心开发，实施和评估实验室活动 完成Immaact的研究议程所必需的。此外，实验室中心将确保 是相关的最先进的专业知识和技术，并监督所有实验室运营，以证实 所有实验室结果都是一致的，可复制的，并且可以支持研究重建。