Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Genital Warts

Intervention / Treatment
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* Drug: GS-9191 ointment
* Drug: GS-9191
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>GS-9191 0.01% ointment | Drug: GS-9191 ointment<br>* 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.<br>|
| Experimental: Cohort 2<br>GS-9191 0.03% ointment | Drug: GS-9191 ointment<br>* 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.<br>|
| Experimental: Cohort 3<br>GS-9191 0.1% ointment | Drug: GS-9191 ointment<br>* 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.<br>|
| Active Comparator: Cohort 4<br>GS-9191 0.3% | Drug: GS-9191<br>* 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.<br>|
| Active Comparator: Cohort 5<br>GS-9191 1.0% | Drug: GS-9191<br>* 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.<br>|
| Placebo Comparator: Cohorts 1, 2, 3, 4 & 5<br>Placebo in all cohorts | Drug: Placebo<br>* Placebo matching GS-9191 ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genital warts, venereal warts, human papilloma virus