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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01040039

Enrollment

Registered

2009-12-25

Start date

2009-11-30

Completion date

2011-09-30

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus, HIV Infections

Keywords

HCV, HIV

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results