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临床试验/NCT01040039
NCT01040039终止不适用

Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV

Rockefeller University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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