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MainTitle

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

This study has been terminated
( Investigator left Rockefeller University )

Sponsor
Rockefeller University


Information provided by (Responsible Party)
Rockefeller University
ClinicalTrials.gov Identifier
NCT01040039

First received: November 19, 2009
Last updated: May 16, 2013
Last Verified: May 2013
History of Changes
Purpose

Purpose

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.

Condition
HIV Infections
Hepatitis C Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV

Further study details as provided by Rockefeller University:

Primary Outcome Measures

  • Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects [ Time Frame: one year ]
Secondary Outcome Measures:
  • Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects [ Time Frame: 1 year ]
  • Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects [ Time Frame: 1 year ]

Biospecimen Retention: Samples With DNA
whole blood, mucosal samples

Estimated Enrollment: 20
Study Start Date: November 2009
Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Arms
HCV+HIV+

HCV+HIV-

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Probability Sample  

Study Population

Healthy volunteers

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040039

Locations

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

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator: Edgar Charles, MD Rockefeller University
More Information

More Information


Responsible Party: Rockefeller University  
ClinicalTrials.gov Identifier: NCT01040039   History of Changes  
Other Study ID Numbers: ECH-0675  
Study First Received: November 19, 2009  
Last Updated: May 16, 2013  

Keywords provided by Rockefeller University:

HCV
HIV

Additional relevant MeSH terms:
Hepatitis C
HIV Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.