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

This study has been terminated.
(Investigator left Rockefeller University)
Sponsor:
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

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, mucosal samples
Estimated Enrollment: 20
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
HCV
HIV

ClinicalTrials.gov processed this record on March 03, 2015