Clinical trial NCT01335230: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Hepatitis C, Chronic
HCV Coinfection
Keywords: HIV
HCV
Hepatitis C
HIV and Hepatitis C coinfection
HIV/HCV
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
measure: Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: M. Tarek Shata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.