TOPICAL MICROBICIDE SAFETY AND EFFICACY EVALUATION

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 这些研究的目的是利用我们建立的局部杀微生物剂安全性和有效性评价模型，通过在非人灵长类动物（NHP）中进行临床前试验，进一步开发旨在预防和控制性传播感染（STI）的局部杀微生物剂。本实验室目前可使用沙眼衣原体和阴道毛滴虫的猕猴模型进行疗效研究。NIAID提供的所有试验产品将首先通过重复阴道内或直肠内产品应用完成安全性评价。具有可接受的安全性特征的产品可入组（经NIAID批准）涉及一种或多种STI的疗效研究。安全性指标包括微生物学和pH值评估以及通过阴道镜评价或直肠灌洗评估证明的粘膜组织反应记录。有效性取决于产品预防挑战病原体感染的能力。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objective of these studies is to further the development of topical microbicides aimed at the prevention and control of sexually transmitted infections (STIs) through preclinical testing in nonhuman primates (NHP), utilizing our established models for topical microbicide safety and efficacy evaluations. Macaque models of Chlamydia trachomatis and Trichomonas vaginalis are currently available for efficacy studies in this laboratory. All test products, provided by NIAID, will first complete safety evaluation with repeated intravaginal or intrarectal product application. Products with acceptable safety profiles may be enrolled (with NIAID approval) to efficacy studies involving one or more STI. Safety measures include microbiologic and pH assessments and documentation of mucosal tissue responses as evidenced by colposcopic evaluation or rectal lavage assessment. Efficacy is determined by a product's ability to prevent infection by the challenge pathogen.