Docosanol and Acyclovir for Treating Genital Herpes

二十二烷醇和阿昔洛韦治疗生殖器疱疹

• 批准号: 6626020
• 负责人: LAURA E POPE
• 金额: $ 50.74万
• 依托单位: AVANIR PHARMACEUTICALS
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-03-01 至 2005-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6626020
• 关键词: Alphaherpesvirinae; Herpes simplex disease; acyclovir; alcohols; antiviral agents; combination chemotherapy; dosage forms; drug design /synthesis /production; drug screening /evaluation; guinea pigs; nonhuman therapy evaluation; topical drug application

DESCRIPTION (Provided by applicant): There is a substantial need for a safe, effective topical treatment for genital herpes simplex (HSV) disease. The proposed research aims to evaluate feasibility of continued development of docosanol as a topical treatment for recurrent genital herpes simplex infections. In order to achieve this objective, we have developed the following specific aims: Aim 1: Develop a new formulation optimized for application to genital areas. Aim 2: Establish efficacy of the new formulation in an animal model of genital herpes. Aim 3: Test selected formulation for safety and tolerability in toxicology studies that meet FDA requirements. Phase II will expand on the Phase I outcome which showed that formulations containing both docosanol and acyclovir provided maximal inhibition of HSV disease in a cutaneous guinea pig model when compared to formulations containing either docosanol or acyclovir alone. Upon successful completion of the aims and establishment of safety and efficacy in the nonclinical models, the applicant intends to initiate Phase 2 and 3 clinical studies of the efficacy of topical docosanol formulations in the treatment of recurrent episodes of genital herpes. If proven safe and effective, it would provide a new single agent treatment as well as allow concurrent use with acyclovir. PROPOSED COMMERCIAL APPLICATION: Topical treatment for recurrent genital herpes infections.

描述（由申请人提供）：非常需要安全， 生殖器疱疹（HSV）疾病的有效局部治疗。这 拟议的研究旨在评估持续发展的可行性 Docosanol作为复发性生殖器疱疹的局部治疗 感染。为了实现这一目标，我们已经开发了以下内容 具体目的： 目标1：开发一种针对生殖区域应用的新配方。 目标2：在生殖器动物模型中确立新配方的功效 疱疹。 AIM 3：测试选定的毒理学安全性和耐受性的配方 满足FDA要求的研究。 第二阶段将扩展I期结果，该结果表明该配方 含有二十醇和acyclovir提供了HSV的最大抑制作用 与配方相比，皮肤豚鼠模型中的疾病 单独包含二战或acyclovir。 成功完成目标并建立安全与功效后 在非临床模型中，申请人打算启动第2阶段和第3阶段 局部二战配方在疗效中的临床研究 生殖疱疹复发发作的处理。如果被证明是安全的，并且 有效，它将提供新的单一代理处理，并允许 同时与Acyclovir一起使用。 拟议的商业应用：复发生殖器疱疹感染的局部治疗。