International Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network

摘要 国际母婴青少年艾滋病临床试验网络(IMPAACT)显著地 进一步努力遏制全球艾滋病毒在孕妇、婴儿、儿童和青少年中的流行 通过进行高质量的临床试验。IMPAACT的愿景和总体目标是结束全球 艾滋病毒在这些脆弱人群中流行。为了实现这一目标，IMPAACT将评估小说和 艾滋病毒和结核病的持久治疗，以建立不含抗逆转录病毒治疗(ART)的战略 缓解，并解决影响这些艾滋病毒感染者和患者的并发症、并存和联合感染 感兴趣的高危人群。我们的研究结果有助于对以下产品进行许可或标签更改 用于感染艾滋病毒的孕妇、婴儿和儿童的新的抗逆转录病毒药物/制剂及其影响 国际和美国针对这些脆弱人群的临床护理指南。除了生成 在这些领域的具体证据，IMPAACT的工作有助于建立亟需的研究和实验室 在资源有限的情况下，艾滋病毒流行病的负担仍然是最大的。IMPAACT 实验室中心是该网络在确定艾滋病毒感染者护理标准方面取得的成功不可或缺的一部分 孕妇、儿童和青少年。许多解释成功的机械论基础 IMPAACT临床试验由IMPAACT实验室中心的研究人员管理和发现。在这 为了竞争性地更新IMPAACT实验室中心，我们建议与运营中心和 统计和数据管理中心负责制定、实施和评估实验室活动 这是完成IMPAACT研究议程所必需的。此外，实验室中心将确保 是否有相关的最先进的专业知识和技术，并监督所有实验室的运作，以确认 所有实验室结果都是一致的，可重复性的，可以支持研究重建。

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.