Clinical trial NCT01040039: Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV
Official title: Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Infections
Hepatitis C Virus
Keywords: HCV
HIV
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

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 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.

Primary outcomes:
measure: Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects
timeFrame: one year
Secondary outcomes:
measure: Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects
timeFrame: 1 year
measure: Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: Edgar Charles, MD
role: PRINCIPAL_INVESTIGATOR
References: