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

This study has been completed.
Sponsor:
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: July 8, 2014
Last verified: July 2014

April 12, 2011
July 8, 2014
April 2011
January 2013   (final data collection date for primary outcome measure)
Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
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
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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
Not Provided
Retention:   Samples With DNA
Description:

Colon tissues

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, Chronic
  • HCV 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2013
January 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 Sharp & Dohme Corp.
Principal Investigator: M. Tarek Shata, MD, PhD University of Cincinnati
University of Cincinnati
July 2014

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