Core--Dendrimer Combo - Macaque Safety Studies

核心--树枝状聚合物组合 - 猕猴安全研究

• 批准号: 7112308
• 负责人: DOROTHY L PATTON
• 金额: $ 21.55万
• 依托单位: STARPHARMA, LTD
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7112308
• 关键词: HIV infections; Macaca nemestrina; antiinfective agents; bacteria characteristic; biological models; biomedical facility; buffers; chemoprevention; cooperative study; cytotoxicity; drug adverse effect; drug screening /evaluation; epithelium; gel; optical tomography; polymers; rectum /anus; sexually transmitted diseases; spermicide; topical drug application; vagina

Topical microbicides represent an important potential strategy for preventing the transmission of human immunodeficiency virus (HIV) and sexually transmitted diseases (STD). It is desirable that a topical microbicide product be effective in preventing HIV and STD infections while not irritating the mucosal surface or adversely affecting normal flora of the vagina or rectum, after single and repeated use. It is essential that the in vivo activity of developing topical microbicide products be evaluated prior to recommendations for widespread intravaginal or rectal use. Because clinical trials are too cumbersome and expensive for screening purposes, animal models need to be used. As the proposed combination topical microbicide formulations evolve, we will assess safety of developing formulations in the rectal and vaginal environments using our established animal models for topical microbicide safety testing. When the lead candidate combination formulation has been selected, based partially on these safety evaluations, it will progress to preliminary clinical studies. These proposed studies play a key role in bridging the gap between laboratory and clinical studies aimed at preventing the spread of HIV/STD.

外用杀菌剂是预防人类免疫缺陷病毒（HIV）和性传播疾病（STD）传播的重要潜在策略。期望局部杀微生物剂产品在单次和重复使用后能够有效预防HIV和STD感染，同时不会刺激粘膜表面或对阴道或直肠的正常菌群产生不利影响。在建议广泛阴道内或直肠使用之前，必须评估开发的外用杀菌剂产品的体内活性。由于临床试验对于筛选目的来说过于繁琐且昂贵，因此需要使用动物模型。随着拟议的组合外用杀菌剂制剂的发展，我们将使用我们建立的外用杀菌剂安全测试动物模型来评估开发制剂在直肠和阴道环境中的安全性。当部分基于这些安全性评估选择主要候选组合制剂后，它将进入初步临床研究。这些拟议的研究在弥合旨在预防艾滋病毒/性病传播的实验室和临床研究之间的差距方面发挥着关键作用。