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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499967
First Posted: July 12, 2007
Last Update Posted: April 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gilead Sciences
July 10, 2007
July 12, 2007
April 9, 2009
August 2007
February 2009   (Final data collection date for primary outcome measure)
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00499967 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Genital Warts
  • Drug: GS-9191 ointment
    GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
  • Drug: GS-9191
    GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
  • Drug: Placebo
    Placebo matching GS-9191 ointment
  • Experimental: Cohort 1
    GS-9191 0.01% ointment
    Intervention: Drug: GS-9191 ointment
  • Experimental: Cohort 2
    GS-9191 0.03% ointment
    Intervention: Drug: GS-9191 ointment
  • Experimental: Cohort 3
    GS-9191 0.1% ointment
    Intervention: Drug: GS-9191 ointment
  • Active Comparator: Cohort 4
    GS-9191 0.3%
    Intervention: Drug: GS-9191
  • Active Comparator: Cohort 5
    GS-9191 1.0%
    Intervention: Drug: GS-9191
  • Placebo Comparator: Cohorts 1, 2, 3, 4 & 5
    Placebo in all cohorts
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
March 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00499967
GS-US-197-0101
No
Not Provided
Not Provided
Elsa Mondou, MD, Gilead Sciences, Inc.
Gilead Sciences
Not Provided
Study Director: Elsa Mondou, MD Gilead Sciences
Gilead Sciences
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP