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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499967
First Posted: July 12, 2007
Last Update Posted: April 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gilead Sciences
  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
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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499967


  Show 25 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Elsa Mondou, MD Gilead Sciences
  More Information

Responsible Party: Elsa Mondou, MD, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00499967     History of Changes
Other Study ID Numbers: GS-US-197-0101
First Submitted: July 10, 2007
First Posted: July 12, 2007
Last Update Posted: April 9, 2009
Last Verified: April 2009

Keywords provided by Gilead Sciences:
genital warts
venereal warts
human papilloma virus

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases