NCT01532102

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Anaconda Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Anogenital Warts
• Condylomata Acuminata
• Human Papillomavirus Infection

Interventions

Type	Name	Description
DRUG	AP611074
DRUG	Placebo	Placebo gel manufactured to appear identical to AP611074 5% gel

Timeline

• Start date: 2012-02-28
• Primary completion: 2013-05-06
• Completion: 2013-05-06
• First posted: 2012-02-14
• Last updated: 2018-05-30

Locations

4 sites across 2 countries: Argentina, France