Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV
Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV
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.
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.
Inclusion Criteria:

 1. Between 18 and 75 years of age.

 2. Ability to give informed consent.

 3. Platelets greater than 70,000/mm3.

 4. Hb at least 9.5 g/dl.

 5. INR < 1.5.

 Exclusion Criteria:

 1. Decompensated cirrhosis.

 2. Serious uncontrolled medical illness.

 3. Ingestion of Aspirin within 72 hours of sigmoidoscopy

 4. Ingestion of non aspirin NSAIDS within 8 hours of sigmoidoscopy

 5. Receipt of immune modulators or suppressors within 30 days prior to study entry,
 including, but not limited to, interferons and thalidomide.

 6. Psychiatric illness or social condition that, in the opinion of the investigator,
 would interfere with adherence to study requirements.

 7. Alcohol or drug use or dependence that, in the opinion of the investigator, would
 interfere with adherence to study requirements.

 8. Medical illness requiring prescribed Aspirin or NSAIDs.