Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

Human Papillomavirus Infection Clinical Trial

Official title: A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).

Clinical Trial Description

Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in > 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection. ;

Related Conditions & MeSH terms

• Anogenital Warts
• Condylomata Acuminata
• Human Papillomavirus Infection
• Papillomavirus Infections
• Warts

• NCT number: NCT01532102
• Study type: Interventional
• Source: Vaxart
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 28, 2012
• Completion date: May 6, 2013