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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

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