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

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00499967

Purpose

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	Intervention	Phase
Genital Warts	Drug: GS-9191 ointment Drug: GS-9191 Drug: Placebo	Phase I

MedlinePlus related topics: Genital Warts Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental 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.
Cohort 2: Experimental 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.
Cohort 3: Experimental 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.
Cohort 4: Active Comparator 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.
Cohort 5: Active Comparator 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.
Cohorts 1, 2, 3, 4 & 5: Placebo Comparator Placebo in all cohorts	Drug: Placebo Placebo matching GS-9191 ointment

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499967

Show 26 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Elsa Mondou, MD

Gilead Sciences

More Information

Responsible Party:	Gilead Sciences, Inc. ( Elsa Mondou, MD )
Study ID Numbers:	GS-US-197-0101
Study First Received:	July 10, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00499967
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Gilead Sciences:

genital warts
venereal warts
human papilloma virus

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Sexually Transmitted Diseases, Viral
Warts
Skin Diseases
Condyloma acuminatum

Condylomata Acuminata
Sexually Transmitted Diseases
Condyloma
DNA Virus Infections
Papillomavirus Infections
Papilloma

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009