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
1 other identifier
interventional
202
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2007
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedApril 9, 2009
April 1, 2009
1.5 years
July 10, 2007
April 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
3 months
Study Arms (6)
Cohort 1
EXPERIMENTALGS-9191 0.01% ointment
Cohort 2
EXPERIMENTALGS-9191 0.03% ointment
Cohort 3
EXPERIMENTALGS-9191 0.1% ointment
Cohort 4
ACTIVE COMPARATORGS-9191 0.3%
Cohort 5
ACTIVE COMPARATORGS-9191 1.0%
Cohorts 1, 2, 3, 4 & 5
PLACEBO COMPARATORPlacebo in all cohorts
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (25)
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
San Francisco, California, 94114, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Santa Rosa, California, 95405, United States
Unknown Facility
Vallejo, California, 94589, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Tampa, Florida, 33607, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
St Louis, Missouri, 63117, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Stony Brook, New York, 11794, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Tulsa, Oklahoma, 74105, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Greenville, South Carolina, 29605, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77058, United States
Unknown Facility
San Antonio, Texas, 78217, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elsa Mondou, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 12, 2007
Study Start
August 1, 2007
Primary Completion
February 1, 2009
Study Completion
March 1, 2009
Last Updated
April 9, 2009
Record last verified: 2009-04