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
Phase 1
18 Years
50 Years
18 Years
50 Years
Not Enrolling
Both
Genital Warts
Both
Genital Warts
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Elsa Mondou, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gilead Sciences
Authority:
United States: Food and Drug Administration
Study ID:
GS-US-197-0101
NCT ID:
NCT00499967
Start Date:
August 2007
Completion Date:
March 2009
Related Keywords:
- Genital Warts
- genital warts
- venereal warts
- human papilloma virus
- Condylomata Acuminata
- Warts
- Papillomavirus Infections
Name | Location |
|---|---|
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Las Vegas, Nevada 89109 | |
| Salt Lake City, Utah 84112 |
