Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00499967 | Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts | PHASE1 | COMPLETED | 202 | — | — | Aug 1, 2007 | Mar 1, 2009 | Apr 9, 2009 | 25 | United States |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
| 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 |
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 treat...