NCT00499967已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 202
- 主要终点
- Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1
Experimental
GS-9191 0.01% ointment
干预措施: GS-9191 ointment (Drug)
Cohort 2
Experimental
GS-9191 0.03% ointment
干预措施: GS-9191 ointment (Drug)
Cohort 3
Experimental
GS-9191 0.1% ointment
干预措施: GS-9191 ointment (Drug)
Cohort 4
Active Comparator
GS-9191 0.3%
干预措施: GS-9191 (Drug)
Cohort 5
Active Comparator
GS-9191 1.0%
干预措施: GS-9191 (Drug)
Cohorts 1, 2, 3, 4 & 5
Placebo Comparator
Placebo in all cohorts
干预措施: Placebo (Drug)
结局指标
主要结局
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
时间窗: 3 months
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male VolunteersMucociliary ClearanceAirway HydrationCystic FibrosisNCT00951522Gilead Sciences15
已完成
1 期
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy VolunteersMucociliary ClearanceAirway HydrationCystic FibrosisNCT00999531Gilead Sciences24
撤回
1 期
GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy SubjectsCOVID-19NCT06274853National Center for Advancing Translational Sciences (NCATS)70
撤回
1 期
A Phase 1 Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF)Cystic FibrosisMucociliary ClearanceNCT01025713Gilead Sciences
已完成
1 期
Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002Colitis, UlcerativeNCT01984047GlaxoSmithKline49