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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00499967
Other study ID # GS-US-197-0101
Secondary ID
Status Completed
Phase Phase 1
First received July 10, 2007
Last updated April 7, 2009
Start date August 2007
Est. completion date March 2009

Study information

Verified date April 2009
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date March 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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
Placebo matching GS-9191 ointment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. 3 months No
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