IMPAACT Leadership Group

国际母婴青少年艾滋病临床试验（IMPAACT）的超额目标 该网络旨在确定安全、可接受、可行和有效的干预措施，以结束艾滋病毒/艾滋病 在全世界婴儿、儿童、青少年以及孕妇和产后妇女中流行。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， 无抗逆转录病毒治疗（ART）缓解策略并解决并发症、合并症和 影响这些人群的合并感染。该网络的具体科学目标是：1）推进抗逆转录病毒治疗 治疗感染艾滋病毒的孕妇和产后妇女，以优化孕产妇和儿童健康 结果，并加速评估（药代动力学（PK），安全性，抗病毒疗效），许可证和 孕妇、婴儿、儿童和青少年最佳使用强效和持久的抗逆转录病毒药物 艾滋病毒; 2）通过旨在预防的治疗干预，评估无ART缓解的潜力， 在感染艾滋病毒的婴儿、儿童和青少年中清除艾滋病毒储存库并进行治疗后控制; 3） 评估孕妇和产后妇女结核病预防、诊断和治疗的新方法， 感染和未感染艾滋病毒的婴儿、儿童和青少年，这将导致最佳剂量、方案、许可证和 改善治疗结果; 4）确定预防和治疗的最佳和可行方法， 艾滋病毒感染并发症和合并感染的管理及其在婴儿、儿童、 青少年和孕妇及产后妇女。该网络将确定和评价最有希望的 以及我们关注人群的相关药物和干预措施，基于有利的安全性，可接受性， 在非妊娠成人中的持久性和有效性特征，用于I-IV期临床研究的评价 研究，遵循序贯药物开发模型。还将进行战略研究， 干预和人口。该网络将酌情采用创新的研究设计， 在保持科学严谨性的同时，最先进的社会行为和药物计量学方法将 纳入IMPAACT研究，以确保对可能影响结果的因素进行适当评估 感兴趣在适当的时候，该网络将对婴儿的药剂/干预措施进行早期评价， 儿童、青少年和孕妇，与其他研究人员进行的研究平行， 在非妊娠成人中使用相同的药物/干预措施。IMPAACT研究预计将在 在非洲、亚洲和美洲有经验的临床研究中心。该网络的研究将得到发展， 并在各级社区投入下进行，并与其他临床试验网络合作， 研究团体、制药行业和其他合作伙伴。具有最高科学价值的研究， 对公共卫生影响潜力最大的项目将优先予以开发和实施。

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.