Clinical trial NCT00499967: Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Genital Warts
Keywords: genital warts
venereal warts
human papilloma virus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: San Fransisco
country: United States
state: California
city: San Fransisco
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Greenville
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Gilead Sciences
name: Elsa Mondou, MD
role: STUDY_DIRECTOR
References: