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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01040039
• Other study ID #: ECH-0675
• Status: Terminated
• Phase: N/A
• First received: November 19, 2009
• Last updated: May 16, 2013
• Start date: November 2009
• Est. completion date: September 2011

Study information

• Verified date: May 2013
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus
• HIV Infections

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects		one year	No
Secondary	Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects		1 year	No
Secondary	Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects		1 year	No