Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | GS-9191 0.01% ointment |
|
| Cohort 2 | Experimental | GS-9191 0.03% ointment |
|
| Cohort 3 | Experimental | GS-9191 0.1% ointment |
|
| Cohort 4 | Active Comparator | GS-9191 0.3% |
|
| Cohort 5 | Active Comparator | GS-9191 1.0% |
|
| Cohorts 1, 2, 3, 4 & 5 | Placebo Comparator | Placebo in all cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9191 ointment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elsa Mondou, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85710 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
|
| GS-9191 | Drug | 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 | Drug | Placebo matching GS-9191 ointment |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Mission Viejo | California | 92691 | United States |
| San Francisco | California | 94114 | United States |
| San Francisco | California | 94115 | United States |
| Santa Rosa | California | 95405 | United States |
| Vallejo | California | 94589 | United States |
| Orlando | Florida | 32803 | United States |
| Tampa | Florida | 33607 | United States |
| Indianapolis | Indiana | 46202 | United States |
| St Louis | Missouri | 63117 | United States |
| Las Vegas | Nevada | 89106 | United States |
| New York | New York | 10016 | United States |
| Stony Brook | New York | 11794 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Tulsa | Oklahoma | 74105 | United States |
| Portland | Oregon | 97239 | United States |
| Greenville | South Carolina | 29605 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77058 | United States |
| San Antonio | Texas | 78217 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Seattle | Washington | 98101 | United States |
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C543852 | GS-9191 |
Not provided
Not provided
Not provided