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
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 do not affect the vital prognostic of a patient, but 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) are not completely efficient, show 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 pathologies caused by HPV
infection.
Main
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment
6 weeks
No
Olivier Chosidow, MD, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
AP611074.CT3
NCT01532102
January 2012
December 2013
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