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

Completed · Phase 1 · Has a placebo group

Conditions studied: Genital Warts

In brief

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.

Key facts

Study ID

NCT00499967

Run by

Gilead Sciences

People needed

202

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2009-04-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Mission Viejo, California, United States
• Study site — San Francisco, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Vallejo, California, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Greenville, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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