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） 进一步努力遏制艾滋病毒在孕妇、婴儿、儿童和青少年中的全球流行 进行高质量的临床试验。IMPAACT的愿景和总体目标是结束全球范围内的 艾滋病毒在这些弱势群体中流行。为了实现这一目标，IMPAACT将评估新的和 艾滋病毒和结核病的持久治疗，以建立无抗逆转录病毒治疗的战略 缓解，并解决影响这些艾滋病毒感染者和 关注的高危人群。我们的研究结果有助于许可证或标签变更， 新的抗逆转录病毒药物/制剂，用于感染艾滋病毒的孕妇、婴儿和儿童， 国际和美国的临床护理指南在这些弱势群体。除了生成 在这些领域的具体证据，IMPAACT的工作已经有助于建立急需的研究和实验室 在资源有限的环境中，艾滋病毒流行病的负担仍然是最大的。影响 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成功不可或缺的一部分。 孕妇、儿童和青少年。许多机械基础，解释了成功的， IMPAACT临床试验由IMPAACT实验室中心研究者管理和发现。在这 IMPAACT实验室中心的竞争性更新，我们建议密切合作的运营中心， 统计和数据管理中心制定、实施和评估实验室活动 完成IMPAACT的研究议程。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，并监督所有实验室操作，确认 所有实验室结果一致、可重现，并可支持研究重建。

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.