IMPAACT Leadership Group

国际母儿青少年艾滋病临床试验(IMPAACT)的总体目标 网络是确定安全、可接受、可行和有效的干预措施，将导致结束艾滋病毒 在世界各地的婴儿、儿童、青少年以及孕妇和产后妇女中流行。要实现 为了实现这一目标，该网络将评估艾滋病毒和结核病(TB)的新的和更持久的治疗方法，并 抗逆转录病毒治疗(ART)的策略--无缓解并解决并发症、合并症和 影响这些人群的混合感染。该网络的科学具体目标是1)推动抗逆转录病毒 治疗孕妇和产后感染艾滋病毒的妇女，旨在优化母婴健康 结果，并加快评价(药代动力学(PK)、安全性、抗病毒疗效)、许可证和 最佳使用有效和持久的抗逆转录病毒药物治疗孕妇、婴儿、儿童和青少年 艾滋病毒；2)评估通过旨在预防的治疗干预措施实现无抗逆转录病毒药物缓解的可能性， 对婴儿、儿童和青少年艾滋病毒携带者的艾滋病毒宿主清除和治疗后控制；3)至 评估孕妇和产后妇女结核病预防、诊断和治疗的新方法 感染和不感染艾滋病毒的婴儿、儿童和青少年，将导致最佳剂量、方案、许可和 改善治疗结果；以及4)确定最佳和可行的预防和治疗方法 婴幼儿HIV感染的并发症和合并感染的处理及治疗 青少年、孕妇和产后妇女。该网络将确定和评估最有希望的 以及对我们感兴趣的人群的相关代理和干预，基于良好的安全性、可接受性、 I-IV期临床研究中用于评估的非妊娠成人的耐受性和有效性 研究，遵循序贯药物开发模式。还将进行战略研究，以便有针对性地 干预措施和人口。该网络将在适当的时候采用创新的研究设计，以加强 在保持科学严谨的同时提高效率。最先进的社会行为和药物计量方法将 纳入综合方案的研究，以确保适当评估可能影响结果的因素 感兴趣的人。在适当情况下，该网络将对婴儿的制剂/干预措施进行早期阶段评估， 儿童、青少年和孕妇与其他研究人员正在进行的研究同时进行 在未怀孕的成年人中使用相同的药物/干预措施。IMPAACT研究预计将在#年进行 在非洲、亚洲和美洲的经验丰富的临床研究地点。该网络的研究将得到发展 并在每个层面上与社区投入并与其他临床试验网络合作进行， 研究小组、制药行业等合作伙伴。具有最高科学价值的研究和 将优先制定和实施对公共卫生影响最大的潜在影响。

The over-arching goal of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is to identify safe, acceptable, feasible and effective interventions that will lead to the end of the HIV epidemic among infants, children, adolescents and pregnant and postpartum women worldwide. To achieve this goal, the Network will evaluate new and longer-lasting treatments for both HIV and tuberculosis (TB) and strategies for antiretroviral treatment (ART)-free remission and address the complications, co-morbidities, and co-infections affecting these populations. The Network’s scientific specific aims are 1) to advance antiretroviral treatment of pregnant and postpartum women with HIV, aiming to optimize maternal and child health outcomes, and to accelerate the evaluation (pharmacokinetics (PK), safety, antiviral efficacy), licensure and optimal use of potent and durable antiretrovirals for pregnant women, infants, children and adolescents with HIV; 2) to evaluate the potential for ART-free remission through therapeutic interventions aimed at prevention, clearance and post-treatment control of HIV reservoirs in infants, children, and adolescents with HIV; 3) to evaluate novel approaches for TB prevention, diagnosis and treatment in pregnant and postpartum women and infants, children and adolescents with and without HIV that will lead to optimal dosing, regimens, licensing and improved treatment outcomes; and 4) to determine optimal and feasible methods for the prevention and management of complications and co-infections of HIV infection and its treatment in infants, children, adolescents and pregnant and postpartum women. The Network will identify and evaluate the most promising and relevant agents and interventions for our populations of interest, based on favorable safety, acceptability, durability and efficacy profiles among non-pregnant adults, for evaluation in phase I-IV clinical research studies, following the sequential drug development model. Strategy studies will also be pursued for targeted interventions and populations. The Network will employ innovative study designs when appropriate to enhance efficiency while maintaining scientific rigor. State-of-the-art socio-behavioral and pharmacometric methods will be integrated into IMPAACT studies to ensure appropriate assessment of factors that may influence outcomes of interest. When appropriate, the Network will pursue early phase evaluation of agents/interventions in infants, children, adolescents and pregnant women in parallel with studies being conducted by other researchers with the same agents/interventions in non-pregnant adults. IMPAACT studies are expected to be conducted at experienced clinical research sites in Africa, Asia, and the Americas. The Network’s research will be developed and conducted with community input at every level and in collaboration with other clinical trials networks, research groups, pharmaceutical industry and other partners. Studies with the highest scientific merit and greatest potential for public health impact will be prioritized for development and implementation.