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

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00499967
First received: July 10, 2007
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Genital Warts
Drug: GS-9191 ointment
Drug: GS-9191
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
GS-9191 0.01% ointment
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.
Experimental: Cohort 2
GS-9191 0.03% ointment
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.
Experimental: Cohort 3
GS-9191 0.1% ointment
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.
Active Comparator: Cohort 4
GS-9191 0.3%
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.
Active Comparator: Cohort 5
GS-9191 1.0%
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.
Placebo Comparator: Cohorts 1, 2, 3, 4 & 5
Placebo in all cohorts
Drug: Placebo
Placebo matching GS-9191 ointment

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499967

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85710
United States, California
Beverly Hills, California, United States, 90211
Mission Viejo, California, United States, 92691
San Fransisco, California, United States, 94115
San Fransisco, California, United States, 94114
Santa Rosa, California, United States, 95405
Vallejo, California, United States, 94589
United States, Florida
Orlando, Florida, United States, 32803
Tampa, Florida, United States, 33607
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Missouri
St. Louis, Missouri, United States, 63117
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New York
New York, New York, United States, 10016
Stony Brook, New York, United States, 11794
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Tulsa, Oklahoma, United States, 74105
United States, Oregon
Portland, Oregon, United States, 97239
United States, South Carolina
Greenville, South Carolina, United States, 29605
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
United States, Texas
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77058
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78217
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Elsa Mondou, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Elsa Mondou, MD, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00499967     History of Changes
Other Study ID Numbers: GS-US-197-0101
Study First Received: July 10, 2007
Last Updated: April 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
genital warts
venereal warts
human papilloma virus

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on September 30, 2014