NCT00052897已完成1 期
A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
研究概览
简要总结
Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in preventing anal cancer.
详细描述
OBJECTIVES:
I. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions.
II. Determine clinical response and histologic/cytologic regression in patients treated with this drug.
III. Determine immune response in patients treated with this drug. IV. Determine the effect of this drug on HIV viral load and CD4 level in these patients.
OUTLINE: This is a dose-escalation study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究者
研究点 (2)
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