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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| M. Tarek Shata, MD, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23940131 | Result | 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. | |
| 23846566 | Result | 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. |
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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.
We enrolled all the planned subjects (40) as suggested in our proposal within 15 months from University of Cincinnati outpatient clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 HIV Mono-infected Subjects | 10 subjects infected with HIV only |
| FG001 | 10 HCV Mono-infected Subjects | 10 subjects infected with HCV only |
| FG002 | 10 HIV/HCV Co-infected Subjects | 10 subjects infected with both HIV and HCV |
| FG003 | 10 Control Subjects | 10 subjects without HIV, HCV, or both |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 HIV Mono-infected Subjects | 10 subjects infected with HIV only |
| BG001 | 10 HCV Mono-infected Subjects | 10 subjects infected with HCV only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All the samples were analyzed for gene array transcriptions and cytokines profiles | Posted | Mean | Standard Deviation | relative expression levels | One year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 HIV Mono-infected Subjects | 10 subjects infected with HIV only |
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small number of subjects enrolled in the study (10 subjects in each group). It is cross-sectional study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Tarek M. shata | University of Cincinnati, Associate Prof., PI. | (513) 558-6110 | mohamed.shata@uc.edu |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Colon tissues
| BG002 | 10 HIV/HCV Co-infected Subjects | 10 subjects infected with both HIV and HCV |
| BG003 | 10 Control Subjects | 10 subjects without HIV, HCV, or both |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 10 HCV Mono-infected Subjects | 10 subjects infected with HCV only |
| OG002 | 10 HIV/HCV Co-infected Subjects | 10 subjects infected with both HIV and HCV |
| OG003 | 10 Control Subjects | 10 subjects without HIV, HCV, or both |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 10 HCV Mono-infected Subjects | 10 subjects infected with HCV only | 0 | 10 | 0 | 10 |
| EG002 | 10 HIV/HCV Co-infected Subjects | 10 subjects infected with both HIV and HCV | 0 | 10 | 0 | 10 |
| EG003 | 10 Control Subjects | 10 subjects without HIV, HCV, or both | 0 | 10 | 0 | 10 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |