Mesalamine to Reduce T Cell Activation in HIV Infection
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|ClinicalTrials.gov Identifier: NCT01090102|
Recruitment Status : Completed
First Posted : March 19, 2010
Results First Posted : August 11, 2014
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Sexually Transmitted Diseases Immune System Diseases Lentivirus Infections Acquired Immunodeficiency Syndrome||Drug: Mesalamine (5-aminosalicylic acid, Apriso) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mesalamine to Reduce T Cell Activation in HIV Infection|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Drug: Mesalamine (5-aminosalicylic acid, Apriso)
Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth).
Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
|Placebo Comparator: Placebo||
Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth).
Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
- Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study [ Time Frame: Week 0, Week 12 ]
- Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover [ Time Frame: Week 12, Week 24 ]Log(10) change in the percentage of activated T cells during the second 12 weeks of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090102
|United States, California|
|University of California, San Francisco-San Francisco General Hospital|
|San Francisco, California, United States, 94110|