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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Genital Warts

Treatments: Drug: GS-9191; Drug: Placebo; Drug: GS-9191 ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499967

GS-US-197-0101

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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202 participants in 6 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

GS-9191 0.01% ointment

Treatment:

Drug: GS-9191 ointment

Cohort 2

Experimental group

Description:

GS-9191 0.03% ointment

Treatment:

Drug: GS-9191 ointment

Cohort 3

Experimental group

Description:

GS-9191 0.1% ointment

Treatment:

Drug: GS-9191 ointment

Cohort 4

Active Comparator group

Description:

GS-9191 0.3%

Treatment:

Drug: GS-9191

Cohort 5

Active Comparator group

Description:

GS-9191 1.0%

Treatment:

Drug: GS-9191

Cohorts 1, 2, 3, 4 & 5

Placebo Comparator group

Description:

Placebo in all cohorts

Treatment:

Drug: Placebo