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: 6809171
• 负责人: DOROTHY L PATTON
• 金额: $ 23.19万
• 依托单位: STARPHARMA, LTD
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6809171
• 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.

局部微生物是防止人类免疫缺陷病毒（HIV）和性传播疾病（STD）传播的重要策略。希望局部菌心生产产物有效预防HIV和性病感染，同时又不刺激粘膜表面或一次性使用后阴道或直肠的正常植物群。在建议广泛的静脉内或直肠使用的建议之前，必须评估开发局部杀菌产物的体内活性。由于临床试验对于筛查目的过于麻烦且昂贵，因此需要使用动物模型。随着拟议组合的局部杀菌剂配方的发展，我们将使用我们已建立的动物模型来评估直肠和阴道环境中开发制剂的安全性，以进行局部杀微生物剂安全测试。当选择了主要候选候选组合配方时，部分基于这些安全评估，它将发展为初步的临床研究。这些提出的研究在弥合旨在防止HIV/STD传播的实验室和临床研究之间的差距中起着关键作用。