Mesalamine to Reduce T Cell Activation in HIV Infection

This study has been completed.
Sponsor:
Collaborators:
California HIV/AIDS Research Program
Salix Pharmaceuticals
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01090102
First received: March 17, 2010
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: May 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infections
Sexually Transmitted Diseases
Immune System Diseases
Lentivirus Infections
Acquired Immunodeficiency Syndrome
Interventions: Drug: Mesalamine (5-aminosalicylic acid, Apriso)
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mesalamine Then Placebo Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
Placebo Then Mesalamine Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).

Participant Flow for 2 periods

Period 1:   First 12 Weeks
    Mesalamine Then Placebo     Placebo Then Mesalamine  
STARTED     15     18  
COMPLETED     11     16  
NOT COMPLETED     4     2  
Withdrawal by Subject                 1                 1  
Adverse Event                 2                 0  
Death                 1                 1  

Period 2:   Second 12 Weeks
    Mesalamine Then Placebo     Placebo Then Mesalamine  
STARTED     11     16  
COMPLETED     11     15  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  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
Mesalamine Then Placebo Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
Placebo Then Mesalamine Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
Total Total of all reporting groups

Baseline Measures
    Mesalamine Then Placebo     Placebo Then Mesalamine     Total  
Number of Participants  
[units: participants]
  15     18     33  
Age  
[units: years]
Median ( Inter-Quartile Range )
  53  
  ( 49 to 62 )  
  60  
  ( 49 to 62 )  
  55  
  ( 49 to 62 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     15     18     33  
Region of Enrollment  
[units: participants]
     
United States     15     18     33  



  Outcome Measures
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1.  Primary:   Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study   [ Time Frame: Week 0, Week 12 ]

2.  Secondary:   Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover   [ Time Frame: Week 12, Week 24 ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ma Somsouk
Organization: University of California, San Francisco
phone: 415-206-6480
e-mail: somsoukma@medsfgh.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01090102     History of Changes
Other Study ID Numbers: 164320
Study First Received: March 17, 2010
Results First Received: May 20, 2014
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board