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Trial record 39 of 39 for:    " February 17, 2010":" March 19, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
Sponsor:
Collaborators:
California HIV/AIDS Research Program
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, 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
Enrollment 33

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mesalamine Then Placebo Placebo Then Mesalamine
Hide Arm/Group Description 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: 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).
Period Title: First 12 Weeks
Started 15 18
Completed 11 16
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             2             0
Death             1             1
Period Title: Second 12 Weeks
Started 11 16
Completed 11 15
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Mesalamine Then Placebo Placebo Then Mesalamine Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 15 18 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants 18 participants 33 participants
53
(49 to 62)
60
(49 to 62)
55
(49 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
15
 100.0%
18
 100.0%
33
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 18 participants 33 participants
15 18 33
1.Primary Outcome
Title Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study
Hide Description [Not Specified]
Time Frame Week 0, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 participant assigned to first receive Mesalamine was excluded from analysis due to having withdrawn participation without receiving the allocated intervention
Arm/Group Title Mesalamine Then Placebo Placebo Then Mesalamine
Hide Arm/Group Description:
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: 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).
Overall Number of Participants Analyzed 14 18
Mean (95% Confidence Interval)
Unit of Measure: Log10(percentage of T cells)
0.03
(-0.14 to 0.20)
-0.01
(-0.10 to 0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mesalamine Then Placebo, Placebo Then Mesalamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover
Hide Description Log(10) change in the percentage of activated T cells during the second 12 weeks of the study
Time Frame Week 12, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mesalamine Then Placebo Placebo Then Mesalamine
Hide Arm/Group Description:
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: 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).
Overall Number of Participants Analyzed 11 16
Mean (95% Confidence Interval)
Unit of Measure: Log10(percentage of T cells)
0.003
(-0.19 to 0.19)
-0.03
(-0.15 to 0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mesalamine Then Placebo, Placebo Then Mesalamine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mesalamine Placebo
Hide Arm/Group Description Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth). Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
All-Cause Mortality
Mesalamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mesalamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/31 (3.23%)   1/29 (3.45%) 
General disorders     
Death *  1/31 (3.23%)  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Mesalamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/31 (6.45%)   0/29 (0.00%) 
General disorders     
Drug relapse *  1/31 (3.23%)  0/29 (0.00%) 
Hepatobiliary disorders     
Liver Cirrhosis *  1/31 (3.23%)  0/29 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01090102     History of Changes
Other Study ID Numbers: 164320
First Submitted: March 17, 2010
First Posted: March 19, 2010
Results First Submitted: May 20, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 13, 2014