Preclinical User Accptability Studies Long Acting Vaginal Gels, Intravaginal Ring

长效阴道凝胶、阴道环的临床前用户可接受性研究

基本信息

批准号：
7418070
负责人：
Kate M Guthrie
金额：
$ 12.95万
依托单位：
IMQUEST BIOSCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-06-27 至 2013-05-31
项目状态：
已结题

项目摘要

The development of safe, effective and acceptable microbicides is imperative in the fight against HIV/AIDS. The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into formulations or devices that successfully deliver those compounds to target tissues, fluids and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, productrelated and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability depends strongly upon delivery systems with biophysical functions and /or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to impact the public health crisis of HIV/AIDS will be largely limited. Project 3 will integrate and extend our growing knowledge and methodologies in preclinical microbicide formulation and delivery device sciences, with their counterpart in early human studies of acceptability. It will extend current behavioral strategies for studying gel acceptability in preclinical frameworks, and expand those strategies to intravaginal ring (IVR) applications. Project 3 will first modify existing behavioral tools that measure topical gel acceptability dimensions for preclinical formulation development; the new tools will incorporate expanded acceptability dimensions to account for the use of long-acting gels and IVR devices developed in this U19. We will then extend our current preclinical in vivo human studies methodology, integrating imaging experiments with behavioral assessment. This will enable joint determination of two critical components of microbicide success: user acceptability and gel functionality. Further, we will use the expanded measures to analyze the correspondence between behavioral measures and biophysical measures, creating a statistical framework enabling prediction of user ratings of long-acting gel experiences from gel performance measures. Finally, we will examine user ratings of acceptability dimensions associated with these delivery systems, and propose initial preclinical standards of acceptability for long-acting gels and IVRs.

在与艾滋病毒/艾滋病的斗争中，必须开发安全，有效且可接受的杀菌剂。微生物剂产品的成功将源自其生物功能和用户的协同作用可接受性。生物功能是安全有效的抗HIV化合物的综合结果将成功输送到靶组织，流体的配方或设备中纳入配方或设备和病原体。可接受性是一种多因素现象，说明个人，二元，生产相关和社会环境增强了妇女使用菌心的决定。可接受性在很大程度上取决于具有生物物理功能和 /或机械和材料的输送系统最有利于人类使用的特性。没有两者，微生物影响公众的潜力艾滋病毒/艾滋病的健康危机将在很大程度上受到限制。项目3将整合并扩展我们不断增长的知识以及临床前微生物配方和输送装置科学的方法论，其对应物在人类早期的可接受性研究中。它将扩展当前研究凝胶的行为策略在临床前框架中的可接受性，并将这些策略扩展到阴道内环（IVR）应用。项目3将首先修改现有的行为工具，以测量局部凝胶可接受性维度临床前制剂的发展；新工具将将扩展的可接受性维度结合到解释了在U19中开发的长效凝胶和IVR设备的使用。然后我们将扩展我们的当前的临床前体内人类研究方法论，将成像实验与行为的整合评估。这将使杀菌剂成功的两个关键组成部分的联合确定：用户可接受性和凝胶功能。此外，我们将使用扩展的措施来分析行为度量与生物物理措施之间的对应关系，创建一个统计框架从凝胶性能度量中对长效凝胶体验的用户评分进行预测。最后，我们将检查与这些交付系统相关的可接受性维度的用户评分，以及提出了长效凝胶和IVR的可接受性的初始临床前标准。