TOPICAL MICROBICIDE SAFETY AND EFFICACY EVALUATION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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估模型，通过在非人类灵长类动物(NHP)中的临床前试验，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。沙眼衣原体和阴道毛滴虫的猕猴模型目前可用于本实验室的疗效研究。由NIAID提供的所有测试产品将首先通过反复使用阴道内或直肠内产品完成安全性评估。安全性可接受的产品可以(在NIAID批准的情况下)参加涉及一种或多种STI的疗效研究。安全措施包括微生物和pH评估，以及镜评估或直肠灌洗评估所证明的粘膜组织反应的记录。疗效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.