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The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01335230
First received: April 12, 2011
Last updated: August 27, 2015
Last verified: August 2015
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Purpose
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.
| Condition |
|---|
| HIV Hepatitis C, Chronic HCV Coinfection |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mohamed Tarek Shata, University of Cincinnati:
Primary Outcome Measures:
- 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
Colon tissues
| Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The investigators plan to enroll 40 human subjects including 10 HIV mono-infected, 10 HCV mono-infected, 10 HIV/HCV co-infected patients, and 10 control subjects from the outpatient clinic at the University of Cincinnati College of Medicine.
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01335230
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335230
Locations
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
Sponsors and Collaborators
University of Cincinnati
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | M. Tarek Shata, MD, PhD | University of Cincinnati |
More Information
Publications:
| Responsible Party: | Mohamed Tarek Shata, Principal Investigator, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01335230 History of Changes |
| Other Study ID Numbers: |
UC 10110905 |
| Study First Received: | April 12, 2011 |
| Results First Received: | June 24, 2013 |
| Last Updated: | August 27, 2015 |
Keywords provided by Mohamed Tarek Shata, University of Cincinnati:
|
HIV HCV Hepatitis C HIV and Hepatitis C coinfection HIV/HCV |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis C Hepatitis C, Chronic Coinfection Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis, Chronic Infection Parasitic Diseases |
ClinicalTrials.gov processed this record on August 18, 2017