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

Gilead Sciences202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

202

Conditions

Genital Warts

Interventions

GS-9191 ointmentDRUG

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-9191DRUG

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.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (25)

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Beverly Hills, California, United States

Outcomes

Primary Outcomes

Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.

Time frame: 3 months

Data from ClinicalTrials.gov

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