The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
Recruitment status was Active, not recruiting
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.
HIV and Hepatitis C Coinfection
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Exploring the Role of Gut-associated TH17 in Microbial Translocation in HIV and HCV/HIV Co-infected Patients|
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
10 HIV mono-infected subjects
10 subjects infected with HIV only
10 HCV mono-infected subjects
10 subjects infected with HCV only
10 HIV/HCV co-infected subjects
10 subjects infected with both HIV and HCV
10 control subjects
10 subjects without HIV, HCV, or both
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335230
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||M. Tarek Shata, MD, PhD||University of Cincinnati|