Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
Phase 1
Completed
- Conditions
- Genital Warts
- Interventions
- Registration Number
- NCT00499967
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 5 GS-9191 GS-9191 1.0% Cohort 1 GS-9191 ointment GS-9191 0.01% ointment Cohort 2 GS-9191 ointment GS-9191 0.03% ointment Cohort 3 GS-9191 ointment GS-9191 0.1% ointment Cohorts 1, 2, 3, 4 & 5 Placebo Placebo in all cohorts Cohort 4 GS-9191 GS-9191 0.3%
- Primary Outcome Measures
Name Time Method Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. 3 months
- Secondary Outcome Measures
Name Time Method