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

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.