Trial Outcomes & Findings for Mesalamine to Reduce T Cell Activation in HIV Infection (NCT NCT01090102)

NCT ID: NCT01090102

Last Updated: 2014-08-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: Week 0, Week 12
• Results posted on: 2014-08-13

Participant Flow

Participant milestones

Measure	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).
First 12 Weeks STARTED	15	18
First 12 Weeks COMPLETED	11	16
First 12 Weeks NOT COMPLETED	4	2
Second 12 Weeks STARTED	11	16
Second 12 Weeks COMPLETED	11	15
Second 12 Weeks NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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).
First 12 Weeks Withdrawal by Subject	1	1
First 12 Weeks Adverse Event	2	0
First 12 Weeks Death	1	1
Second 12 Weeks Withdrawal by Subject	0	1

Baseline Characteristics

Mesalamine to Reduce T Cell Activation in HIV Infection

Baseline characteristics by cohort

Measure	Mesalamine Then Placebo n=15 Participants 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 n=18 Participants 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 n=33 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	60 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	18 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0, Week 12

Population: 1 participant assigned to first receive Mesalamine was excluded from analysis due to having withdrawn participation without receiving the allocated intervention

Outcome measures

Measure	Mesalamine Then Placebo n=14 Participants 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 n=18 Participants 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).
Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study	0.03 Log10(percentage of T cells) Interval -0.14 to 0.2	-0.01 Log10(percentage of T cells) Interval -0.1 to 0.07

SECONDARY outcome

Timeframe: Week 12, Week 24

Log(10) change in the percentage of activated T cells during the second 12 weeks of the study

Outcome measures

Measure	Mesalamine Then Placebo n=11 Participants 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 n=16 Participants 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).
Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover	0.003 Log10(percentage of T cells) Interval -0.19 to 0.19	-0.03 Log10(percentage of T cells) Interval -0.15 to 0.08

Adverse Events

Mesalamine

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mesalamine n=31 participants at risk Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).	Placebo n=29 participants at risk Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
General disorders Death	3.2% 1/31 • 24 weeks	3.4% 1/29 • 24 weeks

Other adverse events

Measure	Mesalamine n=31 participants at risk Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).	Placebo n=29 participants at risk Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
Hepatobiliary disorders Liver Cirrhosis	3.2% 1/31 • 24 weeks	0.00% 0/29 • 24 weeks
General disorders Drug relapse	3.2% 1/31 • 24 weeks	0.00% 0/29 • 24 weeks

Additional Information

Dr. Ma Somsouk

University of California, San Francisco

Phone: 415-206-6480

Email: somsoukma@medsfgh.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place