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
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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:
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Healthy volunteers
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Locations
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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
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
| 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 |
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 |
ClinicalTrials.gov processed this record on September 23, 2016