Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
NCT ID: NCT00499967
Last Updated: 2009-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
202 participants
INTERVENTIONAL
2007-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
GS-9191 0.01% ointment
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.
Cohort 2
GS-9191 0.03% ointment
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.
Cohort 3
GS-9191 0.1% ointment
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.
Cohort 4
GS-9191 0.3%
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.
Cohort 5
GS-9191 1.0%
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.
Cohorts 1, 2, 3, 4 & 5
Placebo in all cohorts
Placebo
Placebo matching GS-9191 ointment
Interventions
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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.
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
Placebo matching GS-9191 ointment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences, Inc.
Principal Investigators
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Elsa Mondou, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Tucson, Arizona, United States
Beverly Hills, California, United States
Mission Viejo, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Vallejo, California, United States
Orlando, Florida, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
New York, New York, United States
Stony Brook, New York, United States
Raleigh, North Carolina, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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GS-US-197-0101
Identifier Type: -
Identifier Source: org_study_id
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