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

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 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Genital Warts Warts

U.S. FDA Resources

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 ]

Enrollment:	202
Study Start Date:	August 2007
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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 25 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Elsa Mondou, MD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Elsa Mondou, MD, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00499967 History of Changes
Other Study ID Numbers:	GS-US-197-0101
Study First Received:	July 10, 2007
Last Updated:	April 7, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

genital warts
venereal warts
human papilloma virus

Additional relevant MeSH terms:

Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013