A Phase 1, Randomized, Double-Blind, Placebo-Controlled Assessment of the Safety, Tolerability, and Activity of GS-9191 Ointment for the Treatment of External Genital and Perianal Warts Caused by Human Papilloma Virus Infection

Gilead Sciences0 sites202 target enrollmentAugust 2007

ConditionsGenital Warts

InterventionsGS-9191 ointment GS-9191 Placebo

DrugsGS-9191 ointment GS-9191 Placebo

Overview

Phase: Phase 1
Intervention: GS-9191 ointment
Conditions: Genital Warts
Sponsor: Gilead Sciences
Enrollment: 202
Primary Endpoint: Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

March 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gilead Sciences

Eligibility Criteria

Inclusion Criteria

•Have 2 or more genital warts of prespecified sizes on external surfaces of the body.
•If HIV positive, have HIV RNA \< 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen

Exclusion Criteria

•Prior genital wart treatment within 8 weeks
•Pregnancy or breast-feeding
•Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis)
•Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months
•Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area