EUCTR2012-005466-34-NL进行中（未招募）不适用
Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men
Academic Medical Center0 个研究点开始时间: 2013年5月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Written informed consent
- •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 3 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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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