- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499967
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
April 7, 2009 updated by: Gilead Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
202
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85710
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California
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Beverly Hills, California, United States, 90211
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Mission Viejo, California, United States, 92691
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San Fransisco, California, United States, 94115
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San Fransisco, California, United States, 94114
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Santa Rosa, California, United States, 95405
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Vallejo, California, United States, 94589
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Florida
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Orlando, Florida, United States, 32803
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Tampa, Florida, United States, 33607
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Indiana
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Indianapolis, Indiana, United States, 46202
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Missouri
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St. Louis, Missouri, United States, 63117
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Nevada
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Las Vegas, Nevada, United States, 89106
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New York
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New York, New York, United States, 10016
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Stony Brook, New York, United States, 11794
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North Carolina
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Raleigh, North Carolina, United States, 27612
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Oklahoma
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Tulsa, Oklahoma, United States, 74105
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Oregon
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Portland, Oregon, United States, 97239
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South Carolina
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Greenville, South Carolina, United States, 29605
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Texas
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77058
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78217
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Utah
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Salt Lake City, Utah, United States, 84132
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Washington
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Seattle, Washington, United States, 98101
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort 1
GS-9191 0.01% ointment
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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
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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
|
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%
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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%
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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
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Placebo matching GS-9191 ointment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
July 10, 2007
First Submitted That Met QC Criteria
July 10, 2007
First Posted (Estimate)
July 12, 2007
Study Record Updates
Last Update Posted (Estimate)
April 9, 2009
Last Update Submitted That Met QC Criteria
April 7, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-197-0101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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