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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
Not Enrolling
Both
Genital Warts

Thank you

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