Mesalamine to Reduce T Cell Activation in HIV Infection
|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
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|