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

Terminated

• Conditions: Hepatitis C Virus; HIV Infections

• Registration Number: NCT01040039
• Lead Sponsor: Rockefeller University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rockefeller University; 🇺🇸 New York, New York, United States