Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts

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

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.

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