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

Primary Purpose

Genital Warts

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GS-9191 ointment
GS-9191
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Warts focused on measuring genital warts, venereal warts, human papilloma virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohorts 1, 2, 3, 4 & 5

Arm Description

GS-9191 0.01% ointment

GS-9191 0.03% ointment

GS-9191 0.1% ointment

GS-9191 0.3%

GS-9191 1.0%

Placebo in all cohorts

Outcomes

Primary Outcome Measures

Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2007
Last Updated
April 7, 2009
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00499967
Brief Title
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts
Keywords
genital warts, venereal warts, human papilloma virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
GS-9191 0.01% ointment
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
GS-9191 0.03% ointment
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
GS-9191 0.1% ointment
Arm Title
Cohort 4
Arm Type
Active Comparator
Arm Description
GS-9191 0.3%
Arm Title
Cohort 5
Arm Type
Active Comparator
Arm Description
GS-9191 1.0%
Arm Title
Cohorts 1, 2, 3, 4 & 5
Arm Type
Placebo Comparator
Arm Description
Placebo in all cohorts
Intervention Type
Drug
Intervention Name(s)
GS-9191 ointment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GS-9191
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching GS-9191 ointment
Primary Outcome Measure Information:
Title
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsa Mondou, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
San Fransisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
City
San Fransisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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

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