The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
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|ClinicalTrials.gov Identifier: NCT01335230|
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : August 5, 2014
Last Update Posted : September 11, 2015
|Condition or disease|
|HIV Hepatitis C, Chronic HCV Coinfection|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Observational Model:||Case Control|
|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|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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
- Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. [ Time Frame: One year ]We measure gene transcription of the colon tissues (relative expression fold changes of gene transcription compared to control). No preselected criteria were used to assess the participants. Data were analyzed and compared among each group. Relative expression levels of LEAP-2 (Liver expressed anti-microbial peptide-2) in the four groups were shown in the table below. Detailed of other genes had been published in Shata MT, et al, J. Clin Pathology 2013, Nov 66(11):967-75. PMID 23940131, and Abdel-Hameed et al, J. Acquir Immune Defic Syndr. 2013 Jul 10 PMID: 23846566
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335230
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||M. Tarek Shata, MD, PhD||University of Cincinnati|