Long-Acting/Extended Release Antiretroviral Resource Program (LEAP)

 描述(由申请人提供)：不完全坚持每日口服抗逆转录病毒制剂是艾滋病毒治疗和暴露前预防(PrEP)有效性的主要障碍。解决这一问题的一个重要而新颖的解决方案是长效/缓释可注射抗逆转录病毒药物(LA/ER ARV)，可以在临床环境中定期给药，消除与服药相关的服药疲劳、健忘、错过剂量和隐私问题。这一战略对弱势群体尤其重要，包括儿童、青少年、孕妇、静脉注射吸毒者，以及当艾滋病毒披露与耻辱和/或暴力风险有关时。由于这些产品的开发是如此复杂和具有挑战性，长效/缓释抗逆转录病毒资源计划(LEAP)将通过利用最佳可用的技术和监管战略确定常见问题的解决方案，帮助研究这些新方法的调查人员。该计划将提供集中的资源，以：1)通过向研究人员提供接触科学、制药、监管和艾滋病毒感染社区的专家来促进创新；2)开发一个基于网络的门户网站，通过创建重要的实验室和临床信息和结果储存库，作为研究人员的通信和数据中心；以及3)提供最先进的基于计算机的建模和模拟服务，将指导新产品的配方、剂量和给药路线的选择。由于LA/ER抗逆转录病毒药物的开发目前存在重大的科学和金融风险，该领域进展缓慢，这样的资源对于促进新化合物和现有化合物的开发是必要的。该计划的预期成果包括更有效地将基于实验室的研究转化为临床试验和最终的药物批准，临床前和临床开发阶段的新产品和配方，为研究人员提供的监管对话和指导，以及印刷和基于网络的出版物，包括对可作为未来产品开发基础的共享数据的系统审查。

 DESCRIPTION (provided by applicant): Imperfect adherence to daily oral antiretroviral formulations is a major obstacle to the effectiveness of HIV therapy and pre-exposure prophylaxis (PrEP). An important and novel solution to this problem is long-acting/extended-release injectable antiretrovirals (LA/ER ARV's) that can be administered periodically in a clinic setting, eliminating the problems of pill fatigue, forgetfulness, missed doses, and privacy concerns related to pill taking. This strategy is especially important for vulnerable populations, including children, adolescents, pregnant women, intravenous drug users, and when HIV disclosure is associated with risk of stigma and/or violence. Because the development of these products is so complex and challenging, the Long Acting/Extended Release Antiretroviral Resource Program (LEAP) will assist investigators working on these new approaches by identifying solutions to common problems that take advantage of the best available technological and regulatory strategies. This program will provide a centralized resource to: 1) facilitate innovation by providing investigators with access to experts from the scientific, pharmaceutical, regulatory, and HIV-affected communities, 2) develop a web-based portal that will serve as a communications and data hub for researchers by creating a repository for important laboratory and clinical information and results, and 3) provide a state-of-the-art computer based modeling and simulation service that will guide selection of formulation, dose, and route of administration for new products. Because development of LA/ER ARV's currently entails significant scientific and financial risks, the field is moving slowly and resources such a these are necessary to facilitate development of new and existing compounds. Expected outcomes of this Program include more efficient translation of laboratory-based research into clinical trials and eventual drug approval, new products and formulations in preclinical and clinical stages of development, regulatory dialog and guidance for investigators, and print and web-based publications including systematic reviews of shared data that can serve as the basis for future product development.