Expired Study
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Cincinnati, Ohio 45267


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.


Study summary:

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.


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


Study is Available At:


Original ID:

UC 10110905


NCT ID:

NCT01335230


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Exploring the Role of Gut-associated TH17 in Microbial Translocation in HIV and HCV/HIV Co-infected Patients


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Cincinnati


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:M. Tarek Shata, MD, PhD
Principal Investigator
University of Cincinnati

Study Dates

Start Date:April 2011
Completion Date:January 2013
Completion Type:Actual
Primary Completion Date:January 2013
Primary Completion Type:Actual
Verification Date:July 2015
Last Changed Date:July 16, 2015
First Received Date:April 12, 2011
First Results Date:June 24, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.
Time Frame:One year
Safety Issues:True
Description: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 expre

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:10 control subjects
Description:10 subjects without HIV, HCV, or both
Study Arm Type:Other
Arm Name:10 HIV/HCV co-infected subjects
Description:10 subjects infected with both HIV and HCV
Study Arm Type:Other
Arm Name:10 HCV mono-infected subjects
Description:10 subjects infected with HCV only
Study Arm Type:Other
Arm Name:10 HIV mono-infected subjects
Description:10 subjects infected with HIV only

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Cincinnati
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck Sharp & Dohme Corp.

Samples and Retentions

Sample Retention:Samples With DNA
Description: Colon tissues
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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation:Shata MT, Abdel-Hameed EA, Hetta HF, Sherman KE. Immune activation in HIV/HCV-infected patients is associated with low-level expression of liver expressed antimicrobial peptide-2 (LEAP-2). J Clin Pathol. 2013 Nov;66(11):967-75. doi: 10.1136/jclinpath-2013-201581. Epub 2013 Aug 12.
PMID:23940131
Reference Type:Results Reference
Citation:Abdel-Hameed EA, Ji H, Sherman KE, Shata MT. Epigenetic modification of FOXP3 in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):19-26. doi: 10.1097/QAI.0b013e3182a1bca4.
PMID:23846566

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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