Our long-term objective is the approval of a new drug application (NDA) for civamide as a topical treatment for herpes simplex virus (HSV) infections. In the United States, genital HSV affects more than 25 million people and oral-facial HSV effects up to 100 million individuals. The enormous number of affected individuals makes this an outstanding commercial opportunity. In previous preclinical studies using the guinea pig model of HSV-type II infection, civamide reduced the severity of both primary and recurrent herpes simplex infections. Most importantly, civamide treatment during primary infection appeared to reduce the severity of subsequent recurrences. This phase I proposal will use this model to further define the mechanism of action of civamide in this disease prior to clinical studies in phase II. Quantitative PCR techniques will be used to determine whether application of civamide is interfering with latency. In addition, by using a vanilloid receptor antagonist, we will determine whether binding of this receptor by civamide is necessary for its efficacy.National Institute of Allergy and Infectious Diseases (NIAID)
