NCT01335230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 5, 2014

Completed
Last Updated

September 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

April 12, 2011

Results QC Date

June 24, 2013

Last Update Submit

August 27, 2015

Conditions

HIVHepatitis C, ChronicHCV Coinfection

Keywords

HIVHCVHepatitis CHIV and Hepatitis C coinfectionHIV/HCV

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (2)

  • 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: 23940131RESULT

  • 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: 23846566RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Colon tissues

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

small number of subjects enrolled in the study (10 subjects in each group). It is cross-sectional study.

Results Point of Contact

Title
Mohamed Tarek M. shata
Organization
University of Cincinnati, Associate Prof., PI.
mohamed.shata@uc.edu
(513) 558-6110

Study Officials

  • M. Tarek Shata, MD, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 14, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

September 11, 2015

Results First Posted

August 5, 2014

Record last verified: 2015-08

Locations

US(1)