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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Hepatitis C, Chronic HCV Coinfection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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10 HIV mono-infected subjects

10 subjects infected with HIV only

No interventions assigned to this group

10 HCV mono-infected subjects

10 subjects infected with HCV only

No interventions assigned to this group

10 HIV/HCV co-infected subjects

10 subjects infected with both HIV and HCV

No interventions assigned to this group

10 control subjects

10 subjects without HIV, HCV, or both

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes