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The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients

University of Cincinnati logo

University of Cincinnati

Status

Completed

Conditions

Hepatitis C, Chronic
HIV
HCV Coinfection

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01335230
UC 10110905

Details and patient eligibility

About

The purpose of this research study is to explore what role immune cells within the gut (the sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or HCV/ HIV co-infection.

Full description

Objective 1: Characterization of the Gut Associated Lymphocytes (GALT) in HIV, HCV and coinfected patients regarding the role of Th17 and cytokine profiles.

Hypothesis 1a: HIV and HCV/HIV coinfection is associated with changes in Th17 numbers and functions in GALT.

Hypothesis 1b: HIV and HCV/HIV coinfection is associated with changes in cytokine profiles in intestinal mucosa.

Objective 2: Identify the relationship between changes in Gut Associated Lymphocytes (GALT) in HIV, HCV and coinfected patients and markers of microbial translocation.

Hypothesis 2a: Changes in GALT are associated with increase in microbial translocation in HIV, HCV and coinfected patients.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • are at least age 18, but not older than 70 years old
  • have HIV, HCV or both
  • do not have HIV, HCV or both, and are having a screening colonoscopy or flexible sigmoidoscopy for abdominal pain or colon cancer screening (control subject)

Exclusion criteria

  • have a history of inflammatory bowel diseases (IBD) or suspected IBD
  • have a history of autoimmune diseases including rheumatoid arthritis
  • are taking systemic immunomodulators
  • are pregnant

Trial design

40 participants in 4 patient groups

10 HIV mono-infected subjects
Description:
10 subjects infected with HIV only
10 HCV mono-infected subjects
Description:
10 subjects infected with HCV only
10 HIV/HCV co-infected subjects
Description:
10 subjects infected with both HIV and HCV
10 control subjects
Description:
10 subjects without HIV, HCV, or both

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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