HIVNCT01335230
The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
An observational study of HIV and Hepatitis C, Chronic, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Hepatitis C, Chronic, HCV Coinfection
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Role of Gut-associated TH17 in Microbial Translocation in HIV and HCV/HIV Co-infected Patients
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.
Read the 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.
- Conditions
- HIV, Hepatitis C, Chronic, HCV Coinfection
- Keywords
- HIV, HCV, Hepatitis C, HIV and Hepatitis C coinfection, HIV/HCV
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mohamed Tarek Shata, University of Cincinnati
- Investigators
- M. Tarek Shata, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335230
- Sponsor's protocol ID
- UC 10110905
- Status last verified
- Aug 2015
- First submitted
- 12 Apr 2011
- Last updated
- 11 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23940131Abdel-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.
PubMed 23846566
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Gut-associated TH17 in Microbial Translocation in HIV and HCV/HIV Co-infected Patients
- ClinicalTrials.gov ID
- NCT01335230
- Acronym / sponsor ID
- UC 10110905
- Conditions
- HIV, Hepatitis C, Chronic, HCV Coinfection
- Keywords
- HIV, HCV, Hepatitis C, HIV and Hepatitis C coinfection, HIV/HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 5 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23940131Shata 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.
- Results publication: PubMed 23846566Abdel-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Tarek Shata, MD, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis C, Chronic, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.