Trial Outcomes & Findings for Modulation of Immune Activation by Aspirin (NCT NCT02155985)
NCT ID: NCT02155985
Last Updated: 2017-06-12
Results Overview
Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded. Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. Differences between arms are expressed as the percent difference between mean fold changes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Pre-entry and entry to weeks 11 and 12
Results posted on
2017-06-12
Participant Flow
The first participant enrolled on August 18, 2014. The last participant enrolled on March 6, 2015.
Participants were randomized to the three study arms using a 1:1:1 allocation ratio with permuted blocks of size 6 and without institutional balancing. There was no stratification.
Participant milestones
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
40
|
|
Overall Study
COMPLETED
|
39
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Modulation of Immune Activation by Aspirin
Baseline characteristics by cohort
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=40 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=41 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=40 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
50 years
n=7 Participants
|
49 years
n=5 Participants
|
49 years
n=4 Participants
|
|
Age, Customized
20 - 29 years
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Age, Customized
30 - 39 years
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Age, Customized
40 - 49 years
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Age, Customized
50 - 59 years
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
13 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Age, Customized
60 - 69 years
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Age, Customized
70 - 79 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
21 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
11 participants
n=5 Participants
|
19 participants
n=7 Participants
|
11 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
40 participants
n=5 Participants
|
121 participants
n=4 Participants
|
|
Smoking Status
Never
|
19 participants
n=5 Participants
|
25 participants
n=7 Participants
|
26 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Smoking Status
Previously
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Smoking Status
Currently
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Statin Use
Off Statins
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
34 participants
n=5 Participants
|
102 participants
n=4 Participants
|
|
Statin Use
Pravastatin
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Statin Use
Atorvastatin
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Statin Use
Rosuvastatin
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
BMI, Continuous
|
25.9 kg/m^2
n=5 Participants
|
25.8 kg/m^2
n=7 Participants
|
27.3 kg/m^2
n=5 Participants
|
26.0 kg/m^2
n=4 Participants
|
|
CD4 Count, Continuous
|
573 cells/mm^3
n=5 Participants
|
629 cells/mm^3
n=7 Participants
|
642 cells/mm^3
n=5 Participants
|
599 cells/mm^3
n=4 Participants
|
|
HIV-1 RNA, Categorical
<40 copies/mL
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
40 participants
n=5 Participants
|
118 participants
n=4 Participants
|
|
HIV-1 RNA, Categorical
41 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
HIV-1 RNA, Categorical
45 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
HIV-1 RNA, Categorical
162 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Platelets, Continuous
|
222.5 10^9/L
n=5 Participants
|
229 10^9/L
n=7 Participants
|
224.5 10^9/L
n=5 Participants
|
226 10^9/L
n=4 Participants
|
|
Hemoglobin, Continuous
|
14.2 g/dL
n=5 Participants
|
14.1 g/dL
n=7 Participants
|
14.2 g/dL
n=5 Participants
|
14.2 g/dL
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-entry and entry to weeks 11 and 12Population: Analysis used the per-protocol population. Participants 1) without baseline AND week 11/12 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) with a serious bacterial infection while on treatment, or 4) with \<70% self-reported adherence (based on all available days of recall) to study treatment were excluded.
Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded. Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. Differences between arms are expressed as the percent difference between mean fold changes.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=38 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=36 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in sCD14 From Baseline to Week 11/12
|
0.99 fold change
Interval 0.94 to 1.04
|
1.03 fold change
Interval 0.98 to 1.08
|
0.97 fold change
Interval 0.93 to 1.02
|
SECONDARY outcome
Timeframe: After study entry to Week 16Population: All randomized participants.
Safety was summarized as the highest grade sign/symptom, laboratory event, or diagnosis per participant. Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=40 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=41 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=40 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Safety
Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety
Grade 0
|
37 Participants
|
37 Participants
|
33 Participants
|
|
Safety
Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety
Grade 2
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Treatment dispensation to Week 12Population: All randomized participants.
Tolerability was summarized as the number of participants successfully completing the protocol-defined treatment period.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=40 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=41 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=40 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Tolerability
|
38 Participants
|
40 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Pre-entry and entry to weeks 11 and 12Population: Analysis used the per-protocol population as in the primary analyses.
Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded. Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=38 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=36 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in sCD163 From Baseline to Week 11/12
|
1.12 fold change
Interval 1.03 to 1.23
|
1.03 fold change
Interval 0.94 to 1.13
|
0.98 fold change
Interval 0.89 to 1.07
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD14dimCD16+ From Entry to Week 12
|
0.13 percentage of CD14dimCD16+
Interval -0.88 to 1.14
|
0.27 percentage of CD14dimCD16+
Interval -0.74 to 1.28
|
0.15 percentage of CD14dimCD16+
Interval -0.86 to 1.16
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD69+ on CD14dimCD16+ From Entry to Week 12
|
-0.12 percent of CD14dimCD16+ expressing CD69+
Interval -4.52 to 4.29
|
-2.22 percent of CD14dimCD16+ expressing CD69+
Interval -6.62 to 2.19
|
1.82 percent of CD14dimCD16+ expressing CD69+
Interval -2.58 to 6.23
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD14+CD16- From Entry to Week 12
|
7.71 percentage of CD14+CD16-
Interval 1.52 to 13.89
|
-0.48 percentage of CD14+CD16-
Interval -6.66 to 5.71
|
2.62 percentage of CD14+CD16-
Interval -3.56 to 8.81
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD69+ on CD14+CD16- From Entry to Week 12
|
4.16 percent of CD14+CD16- expressing CD69+
Interval -2.18 to 10.49
|
-0.27 percent of CD14+CD16- expressing CD69+
Interval -6.6 to 6.07
|
3.33 percent of CD14+CD16- expressing CD69+
Interval -3.01 to 9.66
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD14+CD16+ From Entry to Week 12
|
-7.86 percentage of CD14+CD16+
Interval -14.24 to -1.47
|
0.19 percentage of CD14+CD16+
Interval -6.19 to 6.58
|
-2.88 percentage of CD14+CD16+
Interval -9.26 to 3.51
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD69+ on CD14+CD16+ From Entry to Week 12
|
1.07 percent of CD14+CD16+ expressing CD69+
Interval -5.29 to 7.43
|
-3.48 percent of CD14+CD16+ expressing CD69+
Interval -9.83 to 2.88
|
2.12 percent of CD14+CD16+ expressing CD69+
Interval -4.24 to 8.48
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD38+HLA-DR+ on CD4+ From Entry to Week 12
|
-1.46 percent of CD4+ expressing CD38+HLA-DR+
Interval -2.98 to 0.05
|
-0.94 percent of CD4+ expressing CD38+HLA-DR+
Interval -2.45 to 0.58
|
-0.03 percent of CD4+ expressing CD38+HLA-DR+
Interval -1.56 to 1.51
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of CD38+HLA-DR+ on CD8+ From Entry to Week 12
|
-1.16 percent of CD8+ expressing CD38+HLA-DR+
Interval -2.85 to 0.54
|
-1.47 percent of CD8+ expressing CD38+HLA-DR+
Interval -3.17 to 0.23
|
-0.48 percent of CD8+ expressing CD38+HLA-DR+
Interval -2.21 to 1.24
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of PD-1+ on CD4+ From Entry to Week 12
|
-0.46 percentage of CD4+ expressing PD-1+
Interval -1.81 to 0.88
|
-0.19 percentage of CD4+ expressing PD-1+
Interval -1.53 to 1.16
|
-0.75 percentage of CD4+ expressing PD-1+
Interval -2.11 to 0.62
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=35 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Expression of PD-1+ on CD8+ From Entry to Week 12
|
-0.18 percentage of CD8+ expressing PD-1+
Interval -1.54 to 1.18
|
-0.07 percentage of CD8+ expressing PD-1+
Interval -1.44 to 1.29
|
-0.74 percentage of CD8+ expressing PD-1+
Interval -2.13 to 0.64
|
SECONDARY outcome
Timeframe: Pre-entry and entry to weeks 11 and 12Population: Analysis used the per-protocol population as in the primary analyses.
Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded. Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=38 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=36 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in IL-6 From Baseline to Week 11/12
|
1.03 fold change
Interval 0.87 to 1.21
|
1.13 fold change
Interval 0.96 to 1.33
|
0.92 fold change
Interval 0.78 to 1.09
|
SECONDARY outcome
Timeframe: Pre-entry and entry to weeks 11 and 12Population: Analysis used the per-protocol population as in the primary analyses.
Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded. Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=38 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in D-dimer From Baseline to Week 11/12
|
1.08 fold change
Interval 0.97 to 1.19
|
0.99 fold change
Interval 0.89 to 1.1
|
1.02 fold change
Interval 0.91 to 1.13
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=37 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=35 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Kynurenine to Tryptophan Ratio From Entry to Week 12
|
0.45 1000 ng/ml kynurenine : ng/ml tryptophan
Interval -1.78 to 2.69
|
-2.60 1000 ng/ml kynurenine : ng/ml tryptophan
Interval -4.9 to -0.3
|
-1.26 1000 ng/ml kynurenine : ng/ml tryptophan
Interval -3.59 to 1.07
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=36 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Serum Thromboxane B2 From Entry to Week 12
|
0.28 fold change
Interval 0.2 to 0.38
|
0.20 fold change
Interval 0.15 to 0.28
|
1.21 fold change
Interval 0.86 to 1.69
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=38 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=37 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Urine Thromboxane Per Creatinine From Entry to Week 12
|
0.25 fold change
Interval 0.19 to 0.32
|
0.23 fold change
Interval 0.18 to 0.3
|
0.96 fold change
Interval 0.71 to 1.3
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: Analysis used the per-protocol population as in the primary analyses.
Absolute change was calculated as the value at week 12 minus the value at entry.
Outcome measures
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=34 Participants
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=33 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=32 Participants
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Change in Brachial Artery Flow-mediated Dilation (FMD) From Entry to Week 12
|
-0.32 percentage of brachial artery diameter
Interval -1.17 to 0.54
|
-0.98 percentage of brachial artery diameter
Interval -1.85 to -0.11
|
-0.20 percentage of brachial artery diameter
Interval -1.08 to 0.69
|
Adverse Events
Aspirin 300 mg + Aspirin 100 mg Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin 100 mg + Aspirin 300 mg Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Aspirin 300 mg + Aspirin 100 mg Placebos
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aspirin 300 mg + Aspirin 100 mg Placebo
n=40 participants at risk
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 100 mg + Aspirin 300 mg Placebo
n=41 participants at risk
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin
|
Aspirin 300 mg + Aspirin 100 mg Placebos
n=40 participants at risk
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin
|
|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/40 • From baseline to Week 16.
Protocol required reporting: post-entry signs/symptoms \>=Grade 3, laboratory results \>=Grade 2, new diagnoses and events that led to a change in treatment, regardless of grade. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V1.0, December 2004 (Clarification, August, 2009)) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/41 • From baseline to Week 16.
Protocol required reporting: post-entry signs/symptoms \>=Grade 3, laboratory results \>=Grade 2, new diagnoses and events that led to a change in treatment, regardless of grade. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V1.0, December 2004 (Clarification, August, 2009)) and Expedited AE Manual (V2.0) were used.
|
5.0%
2/40 • From baseline to Week 16.
Protocol required reporting: post-entry signs/symptoms \>=Grade 3, laboratory results \>=Grade 2, new diagnoses and events that led to a change in treatment, regardless of grade. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V1.0, December 2004 (Clarification, August, 2009)) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • From baseline to Week 16.
Protocol required reporting: post-entry signs/symptoms \>=Grade 3, laboratory results \>=Grade 2, new diagnoses and events that led to a change in treatment, regardless of grade. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V1.0, December 2004 (Clarification, August, 2009)) and Expedited AE Manual (V2.0) were used.
|
2.4%
1/41 • From baseline to Week 16.
Protocol required reporting: post-entry signs/symptoms \>=Grade 3, laboratory results \>=Grade 2, new diagnoses and events that led to a change in treatment, regardless of grade. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V1.0, December 2004 (Clarification, August, 2009)) and Expedited AE Manual (V2.0) were used.
|
10.0%
4/40 • From baseline to Week 16.
Protocol required reporting: post-entry signs/symptoms \>=Grade 3, laboratory results \>=Grade 2, new diagnoses and events that led to a change in treatment, regardless of grade. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V1.0, December 2004 (Clarification, August, 2009)) and Expedited AE Manual (V2.0) were used.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60