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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00499967

Collaborator

(none)

202

Enrollment

Locations

Arms

Duration (Months)

8.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genital Warts	Drug: GS-9191 ointment Drug: GS-9191 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Tucson	Arizona	United States	85710
2	Beverly Hills	California	United States	90211
3	Mission Viejo	California	United States	92691
4	San Fransisco	California	United States	94114
5	San Fransisco	California	United States	94115
6	Santa Rosa	California	United States	95405
7	Vallejo	California	United States	94589
8	Orlando	Florida	United States	32803
9	Tampa	Florida	United States	33607
10	Indianapolis	Indiana	United States	46202
11	St. Louis	Missouri	United States	63117
12	Las Vegas	Nevada	United States	89106
13	New York	New York	United States	10016
14	Stony Brook	New York	United States	11794
15	Raleigh	North Carolina	United States	27612
16	Tulsa	Oklahoma	United States	74105
17	Portland	Oregon	United States	97239
18	Greenville	South Carolina	United States	29605
19	Chattanooga	Tennessee	United States	37404
20	Dallas	Texas	United States	75231
21	Houston	Texas	United States	77058
22	San Antonio	Texas	United States	78217
23	San Antonio	Texas	United States	78229
24	Salt Lake City	Utah	United States	84132
25	Seattle	Washington	United States	98101