Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV
( Investigator left Rockefeller University )
Information provided by (Responsible Party)
First received: November 19, 2009
Last updated: May 16, 2013
Last Verified: May 2013
History of Changes
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
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 ]
- 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
|Study Start Date:||November 2009|
|Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
Study PopulationHealthy volunteers
- Between 18 and 75 years of age.
- Ability to give informed consent.
- Platelets greater than 70,000/mm3.
- Hb at least 9.5 g/dl.
- INR < 1.5.
- Decompensated cirrhosis.
- Serious uncontrolled medical illness.
- Ingestion of Aspirin within 72 hours of sigmoidoscopy
- Ingestion of non aspirin NSAIDS within 8 hours of sigmoidoscopy
- Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide.
- Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Medical illness requiring prescribed Aspirin or NSAIDs.
Contacts and LocationsChoosing 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 Show More
|United States, New York|
|New York, New York, United States, 10065|
Sponsors and CollaboratorsRockefeller University
|Principal Investigator:||Edgar Charles, MD||Rockefeller University|
|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
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.