NL-OMON41467已完成2 期
Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men - Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •HIV+, CD4 count > 350/ul,
- •Biopsy-proven intra-anal high-grade AIN caused by HPV16, resistant to, or recurring after previous treatment with cauterization, 5FU or imiquimod. A patient is considered resistant to cauterization if after 2 cauterization sessions still lesions are found. A patient is considered resistant to 5FU or imiquimod if after 4 months of weekly (multiple day) application still lesions are found.
- •Good performance status (a Karnofsky performance score of >=60 [on a scale of 0 to 100, with higher scores indicating better performance status])
- •Normal pretreatment laboratory blood values as described previously
排除标准
- •Immunosuppressive medication or other diseases associated with immunodeficiency
- •Life expectancy < 1 year
- •History of anal carcinoma
- •IFN-a criteria (see SmPC): severe cardiac, thyroid, hepatic or central nervous system disease, including severe depression in the past.
研究者
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