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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01335230
First received: April 12, 2011
Last updated: July 20, 2012
Last verified: July 2012
History of Changes

April 12, 2011
July 20, 2012
April 2011
April 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01335230 on ClinicalTrials.gov Archive Site
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The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
Exploring the Role of Gut-associated TH17 in Microbial Translocation in HIV and HCV/HIV Co-infected Patients

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.
  • HIV
  • Hepatitis C
  • HIV and Hepatitis C Coinfection
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01335230
UC 10110905
No
Mohamed Tarek Shata, University of Cincinnati
University of Cincinnati
Merck
Principal Investigator: M. Tarek Shata, MD, PhD University of Cincinnati
University of Cincinnati
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP