HPVinHIV: Study of Anal HPV Infection in the Setting of HIV Infected Individuals
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in the number of HPV positive anal swabs
研究概览
简要总结
Published studies suggest that oral probiotic intake can promote the clearance of HPV genital infection and HPV related genital dysplasia in HIV negative women. In the present randomized, double blind, placebo controlled study, investigators will evaluate the ability of oral bacterio-therapy to enhance the clearance of anal HPV infection and anal HPV related dysplasia in HIV infected subjects.
Participants will be evaluated for anal HPV infection and anal dysplasia before and after a 6 months course of daily investigational product intake (Viviomixx® or placebo). HPV infection rate and presence of dysplasia at baseline and at the end of the study will be compared.
详细描述
Squamous Cell Carcinoma (SCC) of the anus and the anal canal represents a major concern for the HIV infected population, with incidence rates in the different sub populations (women, men, MSM) that are grater than those observed for other common neoplasms in the same HIV negative sub-populations. Nowadays, screening for anal precancerous dysplasia has been included in most national and international HIV management guidelines; in particular, italian guidelines suggest to screen for the presence of HPV related dysplasia:
- HIV+ MSM
- All individuals with previous or current evidence of ant-genital condyloma
- Women with cytology abnormalities on cervical Pap-smear Since no direct anti-HPV drug is currently available and control or clearance of the infection is possible only trough the effect of immune response, interest is addressed to find strategies to promote spontaneous clearance of infection.
In published studies, oral bacterio-therapy demonstrated the ability to promote HPV clearance and HPV related dysplasia regression in HIV negative women.
In the present randomized, double blind, placebo controlled trial, 40 HIV infected individuals with HPV related anal dysplasia will be enrolled.
At baseline participants will undergo:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected individuals >18 years old
- •stable and effective antiretroviral therapy since at least 12 months
- •HPV associated anal dysplasia
- •patient willing to provide written informed consent
排除标准
- •impossibility to intake the investigational product
- •any contraindication to blood sampling
- •inflammatory bowel disease
- •use of antibiotics during the 3 months prior to the enrollment in the study
- •pregnancy
研究组 & 干预措施
Oral Bacteriotherapy Arm
Individuals in this study arm will undergo 6 months of daily intake of an oral probiotic formulation (Vivomixx: 4 sachets/day, each sachet containing 450 billion live bacteria). Probiotic sachets are indistinguishable from placebo
干预措施: Vivomixx (Dietary Supplement)
Placebo Arm
Individuals in this study arm will undergo 6 months of daily intake of placebo (4 sachets/day). Placebo sachets are indistinguishable from probiotic
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in the number of HPV positive anal swabs
时间窗: Anal swabs for HPV detection and genotyping will be performed at baseline and after the 6 months duration of the intervention
Clearance of anal HPV infection will be defined as: * negative swab at the end of the study in participants with positive swab at baseline * positive swab at the end of the study that shows a different genotype from baseline
Change from baseline in the number of dysplastic lesions
时间窗: Areas of the anal canal that were biopsied at baseline and whom histology showed the presence of dysplasia will undergo a second biopsy after the 6 months duration of the intervention
Clearance of anal dysplasia will be defined as: - normal histology in biopsies repeated at the end of the study on areas that showed the presence of histologically defined dysplasia at baseline.
次要结局
- Comparison between intra-epithelial CD4+ T lymphocytes subpopulation in normal mucosa and dysplastic mucosa(Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention)
- Rate of adverse events(This measure will be assessed after the 6 months duration of the intervention)
- Comparison between intra-epithelial NK lymphocytes subpopulation in normal mucosa and dysplastic mucosa(Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention)
- Comparison between intra-epithelial CD8+ T lymphocytes subpopulation in normal mucosa and dysplastic mucosa(Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention)
研究者
Prof. Gabriella d'Ettorre
Professor
University of Roma La Sapienza