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