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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
HIV Hepatitis C, Chronic HCV Coinfection

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.


Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 40 participants
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
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Mohamed Tarek Shata, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01335230     History of Changes
Other Study ID Numbers: UC 10110905
First Posted: April 14, 2011    Key Record Dates
Results First Posted: August 5, 2014
Last Update Posted: September 11, 2015
Last Verified: August 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