Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of HPV subtypes in HIV-positive patients
研究概览
简要总结
The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures)
- •Referred for high-resolution anoscopy
排除标准
- •Documented AIN (treated or untreated)
- •Local anal inflammation (proctitis) and/or acute fissure
研究组 & 干预措施
HPV genotyping
干预措施: HPV genotyping (Diagnostic Test)
结局指标
主要结局
Incidence of HPV subtypes in HIV-positive patients
时间窗: 1 minute
Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment
次要结局
- Correlation between high-resolution anoscopy findings and quantitative HPV genotyping(30 minutes up to 10 days)
研究者
prof. dr. Philip Roelandt
Assistant head of clinic Gastroenterology
Universitaire Ziekenhuizen KU Leuven