HCV Coinfection, Hepatitis C, Chronic, HIV
Conditions
Keywords
HIV, HCV, Hepatitis C, HIV and Hepatitis C coinfection, HIV/HCV
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
University of Cincinnati
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. | One year | 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 |
Countries
United States
Participant flow
Recruitment details
We enrolled all the planned subjects (40) as suggested in our proposal within 15 months from University of Cincinnati outpatient clinic
Pre-assignment details
We excluded patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases including rheumatoid arthritis, and any patients on systemic immunomodulators. Pregnant women were also excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| 10 HIV Mono-infected Subjects 10 subjects infected with HIV only | 10 |
| 10 HCV Mono-infected Subjects 10 subjects infected with HCV only | 10 |
| 10 HIV/HCV Co-infected Subjects 10 subjects infected with both HIV and HCV | 10 |
| 10 Control Subjects 10 subjects without HIV, HCV, or both | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | 10 HCV Mono-infected Subjects | 10 HIV/HCV Co-infected Subjects | 10 HIV Mono-infected Subjects | 10 Control Subjects | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Age, Continuous | 56.8 years STANDARD_DEVIATION 6.5 | 49.1 years STANDARD_DEVIATION 6.2 | 43.5 years STANDARD_DEVIATION 10.7 | 56 years STANDARD_DEVIATION 6.8 | 51.4 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 10 participants | 40 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 10 Participants | 4 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.
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
Time frame: One year
Population: All the samples were analyzed for gene array transcriptions and cytokines profiles
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 HIV Mono-infected Subjects | Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. | 5.8 relative expression levels | Standard Deviation 0.4 |
| 10 HCV Mono-infected Subjects | Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. | 5.84 relative expression levels | Standard Deviation 0.5 |
| 10 HIV/HCV Co-infected Subjects | Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. | 5.84 relative expression levels | Standard Deviation 0.5 |
| 10 Control Subjects | Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. | 6.9 relative expression levels | Standard Deviation 0.6 |