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

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ClinicalTrials.gov Identifier: NCT01040039
Recruitment Status : Terminated (Investigator left Rockefeller University)
First Posted : December 25, 2009
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV
Study Start Date : November 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Group/Cohort
HCV+HIV+
HCV+HIV-


Outcome Measures
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Primary Outcome Measures :
  1. Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects [ Time Frame: 1 year ]
  2. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01040039     History of Changes
Other Study ID Numbers: ECH-0675
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by Rockefeller University:
HCV
HIV

Additional relevant MeSH terms:
Hepatitis C
HIV Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
 Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases