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

Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected 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.

Study Overview

• Status: Terminated
• Conditions: HIV Infections; Hepatitis C Virus

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HCV+HIV+
HCV+HIV-

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Edgar Charles, MD, Rockefeller University

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: November 19, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 25, 2009

Study Record Updates

• Last Update Posted (Estimate): May 17, 2013
• Last Update Submitted That Met QC Criteria: May 16, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: HIV; HCV
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: ECH-0675

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No