Text Size

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
  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
HIV and Hepatitis C 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:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 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
Genders Eligible for Study:   Both
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
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
Investigators
Principal Investigator: M. Tarek Shata, MD, PhD University of Cincinnati
  More Information

No publications provided

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
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
HIV
HCV
Hepatitis C
HIV and Hepatitis C coinfection
HIV/HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on March 03, 2013