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

Genital Warts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499967
• Other study ID #: GS-US-197-0101
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2007
• Last updated: April 7, 2009
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• Warts

Intervention

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.
• 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.
• Placebo
Placebo matching GS-9191 ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.		3 months	No