The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01335230
First received: April 12, 2011
Last updated: July 8, 2014
Last verified: July 2014
Results First Received: June 24, 2013  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Cross-Sectional
Conditions: HIV
Hepatitis C, Chronic
HCV Coinfection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We enrolled all the planned subjects (40) as suggested in our proposal within 15 months from University of Cincinnati outpatient clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    10 HIV Mono-infected Subjects     10 HCV Mono-infected Subjects     10 HIV/HCV Co-infected Subjects     10 Control Subjects  
STARTED     10 [1]   10 [1]   10 [1]   10 [1]
COMPLETED     10 [1]   10 [1]   10 [1]   10 [1]
NOT COMPLETED     0     0     0     0  
[1] subjects



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    10 HIV Mono-infected Subjects     10 HCV Mono-infected Subjects     10 HIV/HCV Co-infected Subjects     10 Control Subjects     Total  
Number of Participants  
[units: participants]
  10     10     10     10     40  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     10     10     10     10     40  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.5  ± 10.7     56.8  ± 6.5     49.1  ± 6.2     56  ± 6.8     51.4  ± 9.3  
Gender  
[units: participants]
         
Female     0     3     3     6     12  
Male     10     7     7     4     28  
Region of Enrollment  
[units: participants]
         
United States     10     10     10     10     40  



  Outcome Measures

1.  Primary:   Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small number of subjects enrolled in the study (10 subjects in each group). It is cross-sectional study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mohamed Tarek M. shata
Organization: University of Cincinnati, Associate Prof., PI.
phone: (513) 558-6110
e-mail: mohamed.shata@uc.edu


Publications of Results:

Responsible Party: Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01335230     History of Changes
Other Study ID Numbers: UC 10110905
Study First Received: April 12, 2011
Results First Received: June 24, 2013
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board