Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects
研究概览
简要总结
This pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV- volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy.
详细描述
Hepatitis C virus (HCV) infects approximately 170 million people worldwide and is the leading indication of liver transplantation in the United States. HCV is primarily a blood-borne infection, and heterosexual transmission is rare. However, acute HCV infection is increasingly being reported among HIV-positive men who have sex with men (MSM) with no risk factors for parenteral HCV transmission, suggestive of a possible mucosal route of infection in these individuals. While it is possible that HCV may be transmitted into the bloodstream via mucosal tears induced by sexual activity, is also possible that a mucosal immune defect predisposes HIV+ persons to mucosal HCV transmission. Our pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV- volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy. We will isolate peripheral and mucosal mononuclear cells and we will perform HCV-specific ELISPOT and single B cell immunoglobulin (Ig) RT-PCR to assess volunteers' gut B cell repertoire. If successful, we would like to expand the study so as to better assess Ig repertoire differences among HCV+HIV+ and HCV+HIV- individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 75 years of age.
- •Ability to give informed consent.
- •Platelets greater than 70,000/mm
- •Hb at least 9.5 g/dl.
- •INR < 1.5.
排除标准
- •Decompensated cirrhosis.
- •Serious uncontrolled medical illness.
- •Ingestion of Aspirin within 72 hours of sigmoidoscopy
- •Ingestion of non aspirin NSAIDS within 8 hours of sigmoidoscopy
- •Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide.
- •Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
- •Alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- •Medical illness requiring prescribed Aspirin or NSAIDs.
结局指标
主要结局
Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects
时间窗: one year
次要结局
- Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects(1 year)
- Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects(1 year)
