NL-OMON44810已完成4 期
Quadrivalent HPV vaccination after effective treatment of Anal Intraepithelial Neoplasia in HIV+ men (VACCAIN-P) - HPV vaccination after treatment of anal intraepithelial neoplasia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent
- •HIV+ males having sex with males (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
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 carcinoma
研究者
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