Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-03 @ 1:59 AM
Study NCT ID:
NCT00499967
Status:
COMPLETED
Last Update Posted:
2009-04-09
First Post:
2007-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543852', 'term': 'GS-9191'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-07', 'studyFirstSubmitDate': '2007-07-10', 'studyFirstSubmitQcDate': '2007-07-10', 'lastUpdatePostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genital warts', 'venereal warts', 'human papilloma virus'], 'conditions': ['Genital Warts']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have 2 or more genital warts of prespecified sizes on external surfaces of the body.\n* If HIV positive, have HIV RNA \\< 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen\n\nExclusion Criteria:\n\n* Prior genital wart treatment within 8 weeks\n* Pregnancy or breast-feeding\n* Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis)\n* Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months\n* Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area'}, 'identificationModule': {'nctId': 'NCT00499967', 'briefTitle': 'Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GS-US-197-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'GS-9191 0.01% ointment', 'interventionNames': ['Drug: GS-9191 ointment']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'GS-9191 0.03% ointment', 'interventionNames': ['Drug: GS-9191 ointment']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'GS-9191 0.1% ointment', 'interventionNames': ['Drug: GS-9191 ointment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 4', 'description': 'GS-9191 0.3%', 'interventionNames': ['Drug: GS-9191']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 5', 'description': 'GS-9191 1.0%', 'interventionNames': ['Drug: GS-9191']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohorts 1, 2, 3, 4 & 5', 'description': 'Placebo in all cohorts', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GS-9191 ointment', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'GS-9191', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 4', 'Cohort 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching GS-9191 ointment', 'armGroupLabels': ['Cohorts 1, 2, 3, 4 & 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '74105', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Elsa Mondou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elsa Mondou, MD', 'oldOrganization': 'Gilead Sciences, Inc.'}}}}