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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00499967 |
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.
Condition | Intervention | Phase |
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Genital Warts |
Drug: GS-9191 ointment Drug: GS-9191 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 200 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 1: Experimental
GS-9191 0.01% ointment
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Drug: 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.
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Cohort 2: Experimental
GS-9191 0.03% ointment
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Drug: 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.
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Cohort 3: Experimental
GS-9191 0.1% ointment
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Drug: 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.
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Cohort 4: Active Comparator
GS-9191 0.3%
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Drug: 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.
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Cohort 5: Active Comparator
GS-9191 1.0%
|
Drug: 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.
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Cohorts 1, 2, 3, 4 & 5: Placebo Comparator
Placebo in all cohorts
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Drug: Placebo
Placebo matching GS-9191 ointment
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Elsa Mondou, MD | Gilead Sciences |
Responsible Party: | Gilead Sciences, Inc. ( Elsa Mondou, MD ) |
Study ID Numbers: | GS-US-197-0101 |
Study First Received: | July 10, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00499967 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
genital warts venereal warts human papilloma virus |
Virus Diseases Skin Diseases, Infectious Sexually Transmitted Diseases, Viral Warts Skin Diseases Condyloma acuminatum |
Condylomata Acuminata Sexually Transmitted Diseases Condyloma DNA Virus Infections Papillomavirus Infections Papilloma |
Skin Diseases, Viral Neoplasms Tumor Virus Infections |