NCT01946009已完成不适用
A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of patients with complete regression of anal intraepithelial neoplasia
研究概览
简要总结
Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.
- •Adult patients (18 years) with documented HIV infection, with high-grade AIN demonstrated by biopsy, and have not received any prior treatment for Anal Intraepithelial Neoplasia in the last 12 weeks.
- •For women of childbearing potential, negative pregnancy test in urine screening visit. All women of childbearing age should continue effective contraception throughout the study treatment.
排除标准
- •Patients who have received previous treatment of Anal Intraepithelial Neoplasia (AIN) in the last 12 weeks.
- •Dermatoses in patients with anogenital area
- •Patients with a history of pre-invasive neoplasia associated with Human Papilloma Virus
- •Patients with a history of previous neoplasm, of any origin and location, in the past 5 years.
- •Patients with a history of hematologic abnormalities, kidney or liver
- •Pregnant or breastfeeding women or women of childbearing age who do not wish to use adequate contraception at the discretion of the investigator.
- •Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.
研究组 & 干预措施
Cidofovir 1%
Experimental
Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
干预措施: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. (Drug)
结局指标
主要结局
Percentage of patients with complete regression of anal intraepithelial neoplasia
时间窗: 8 Weeks
Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN), as confirmed by means of high-resolution anoscopy and biopsy
次要结局
- Time to relapse(8 Weeks)
- Treatment effect(8 Weeks)
- Percentage of adverse events(8 weeks)
- Describe the percentage of patients that reduce the degree of Anal dysplasia(8 weeks)
- Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression(8 Weeks)
- Percentage of patients with clear of Human papillomavirus(8 Weeks)
研究者
研究点 (1)
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