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

PHASE1CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

February 28, 2009

Study Completion Date

March 31, 2009

Conditions
Genital Warts
Interventions
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.

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.

DRUG

Placebo

Placebo matching GS-9191 ointment

Trial Locations (25)

10016

New York

11794

Stony Brook

27612

Raleigh

29605

Greenville

32803

Orlando

33607

Tampa

37404

Chattanooga

46202

Indianapolis

63117

St Louis

74105

Tulsa

75231

Dallas

77058

Houston

78217

San Antonio

78229

San Antonio

84132

Salt Lake City

85710

Tucson

89106

Las Vegas

90211

Beverly Hills

92691

Mission Viejo

94114

San Francisco

94115

San Francisco

94589

Vallejo

95405

Santa Rosa

97239

Portland

98101

Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY