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

November 19, 2009
May 16, 2013
November 2009
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01040039 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, mucosal samples

Probability Sample

Healthy volunteers

  • HIV Infections
  • Hepatitis C Virus
Not Provided
  • HCV+HIV+
  • HCV+HIV-
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01040039
ECH-0675
No
Rockefeller University
Rockefeller University
Not Provided
Principal Investigator: Edgar Charles, MD Rockefeller University
Rockefeller University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP