EUCTR2013-002009-70-NL进行中（未招募）1 期
Quadrivalent HPV vaccination after effective treatment of Anal Intraepithelial Neoplasia in HIV+ men - VACCAIN-P
Academic Medical Center0 个研究点目标入组 125 人开始时间: 2013年9月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
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
入选标准
- •Written informed consent
- •HIV+ MSM, CD4 count > 350/ul.
- •Biopsy-proven intra-anal high-grade AIN successfully treated in the past year with cauterization, cryotherapy, Efudix, imiquimod or another form of local treatment. Lesions with regression from HG to Low grade (LG) AIN will also be eligible.
- •Lesion (still) in remission at the moment of first vaccination (a maximum interval of 6 weeks between last HRA and first vaccination is allowed).
- •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
- •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 120
- •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 less than one year
- •Previous vaccination with the bivalent or quadrivalent HPV vaccine
- •History of anal cancer
研究者
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