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Modulation of Immune Activation by Aspirin

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ClinicalTrials.gov Identifier: NCT02155985
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : July 7, 2016
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: Aspirin
Drug: Placebo
Enrollment 121
Recruitment Details The first participant enrolled on August 18, 2014. The last participant enrolled on March 6, 2015.
Pre-assignment Details 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.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 40 41 40
Completed 39 41 39
Not Completed 1 0 1
Reason Not Completed
Withdrawal by Subject             0             0             1
Lost to Follow-up             1             0             0
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 40 41 40 121
Hide Baseline Analysis Population Description
121 randomized participants, all of which did initiate study treatment.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 40 participants 121 participants
48
(38 to 54)
50
(46 to 56)
49
(42 to 57)
49
(42 to 55)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 40 participants 121 participants
20 - 29 years 5 1 1 7
30 - 39 years 7 5 7 19
40 - 49 years 10 12 13 35
50 - 59 years 15 18 13 46
60 - 69 years 3 4 5 12
70 - 79 years 0 1 1 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 40 participants 121 participants
Female
8
  20.0%
10
  24.4%
5
  12.5%
23
  19.0%
Male
32
  80.0%
31
  75.6%
35
  87.5%
98
  81.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 40 participants 121 participants
White Non-Hispanic 21 18 21 60
Black Non-Hispanic 11 19 11 41
Hispanic (Regardless of Race) 7 4 8 19
Asian, Pacific Islander 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 41 participants 40 participants 121 participants
40 41 40 121
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 40 participants 121 participants
Never 19 25 26 70
Previously 11 7 6 24
Currently 10 9 8 27
Statin Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 40 participants 121 participants
Off Statins 33 35 34 102
Pravastatin 3 0 3 6
Atorvastatin 3 5 3 11
Rosuvastatin 1 1 0 2
BMI, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 41 participants 40 participants 121 participants
25.9
(23.5 to 28.1)
25.8
(22.8 to 30.2)
27.3
(23.7 to 30.1)
26.0
(23.4 to 29.2)
CD4 Count, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 40 participants 41 participants 40 participants 121 participants
573
(436 to 684)
629
(481 to 856)
642
(436 to 747)
599
(456 to 777)
HIV-1 RNA, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 40 participants 121 participants
<40 copies/mL 40 38 40 118
41 copies/mL 0 1 0 1
45 copies/mL 0 1 0 1
162 copies/mL 0 1 0 1
Platelets, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  10^9/L
Number Analyzed 40 participants 41 participants 40 participants 121 participants
222.5
(192 to 251)
229
(200 to 271)
224.5
(184 to 258.5)
226
(192 to 261)
Hemoglobin, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  g/dL
Number Analyzed 40 participants 41 participants 40 participants 121 participants
14.2
(13.4 to 15.0)
14.1
(13.6 to 15.0)
14.2
(13.4 to 15.4)
14.2
(13.4 to 15.1)
1.Primary Outcome
Title Change in sCD14 From Baseline to Week 11/12
Hide Description

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.

Time Frame Pre-entry and entry to weeks 11 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 38 36
Mean (95% Confidence Interval)
Unit of Measure: fold change
0.99
(0.94 to 1.04)
1.03
(0.98 to 1.08)
0.97
(0.93 to 1.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin 300 mg + Aspirin 100 mg Placebo, Aspirin 300 mg + Aspirin 100 mg Placebos
Comments Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-5.5 to 8.8
Estimation Comments Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) * 100.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aspirin 100 mg + Aspirin 300 mg Placebo, Aspirin 300 mg + Aspirin 100 mg Placebos
Comments Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
-1.7 to 13.3
Estimation Comments Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) * 100.
2.Secondary Outcome
Title Safety
Hide Description

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.

Time Frame After study entry to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 40 41 40
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0
37
  92.5%
37
  90.2%
33
  82.5%
Grade 1
1
   2.5%
1
   2.4%
1
   2.5%
Grade 2
2
   5.0%
2
   4.9%
4
  10.0%
Grade 3
0
   0.0%
1
   2.4%
2
   5.0%
3.Secondary Outcome
Title Tolerability
Hide Description Tolerability was summarized as the number of participants successfully completing the protocol-defined treatment period.
Time Frame Treatment dispensation to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 40 41 40
Measure Type: Count of Participants
Unit of Measure: Participants
38
  95.0%
40
  97.6%
38
  95.0%
4.Secondary Outcome
Title Change in sCD163 From Baseline to Week 11/12
Hide Description

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.

Time Frame Pre-entry and entry to weeks 11 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 38 36
Mean (95% Confidence Interval)
Unit of Measure: fold change
1.12
(1.03 to 1.23)
1.03
(0.94 to 1.13)
0.98
(0.89 to 1.07)
5.Secondary Outcome
Title Change in Expression of CD14dimCD16+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percentage of CD14dimCD16+
0.13
(-0.88 to 1.14)
0.27
(-0.74 to 1.28)
0.15
(-0.86 to 1.16)
6.Secondary Outcome
Title Change in Expression of CD69+ on CD14dimCD16+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percent of CD14dimCD16+ expressing CD69+
-0.12
(-4.52 to 4.29)
-2.22
(-6.62 to 2.19)
1.82
(-2.58 to 6.23)
7.Secondary Outcome
Title Change in Expression of CD14+CD16- From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percentage of CD14+CD16-
7.71
(1.52 to 13.89)
-0.48
(-6.66 to 5.71)
2.62
(-3.56 to 8.81)
8.Secondary Outcome
Title Change in Expression of CD69+ on CD14+CD16- From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percent of CD14+CD16- expressing CD69+
4.16
(-2.18 to 10.49)
-0.27
(-6.60 to 6.07)
3.33
(-3.01 to 9.66)
9.Secondary Outcome
Title Change in Expression of CD14+CD16+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percentage of CD14+CD16+
-7.86
(-14.24 to -1.47)
0.19
(-6.19 to 6.58)
-2.88
(-9.26 to 3.51)
10.Secondary Outcome
Title Change in Expression of CD69+ on CD14+CD16+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percent of CD14+CD16+ expressing CD69+
1.07
(-5.29 to 7.43)
-3.48
(-9.83 to 2.88)
2.12
(-4.24 to 8.48)
11.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD4+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percent of CD4+ expressing CD38+HLA-DR+
-1.46
(-2.98 to 0.05)
-0.94
(-2.45 to 0.58)
-0.03
(-1.56 to 1.51)
12.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD8+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percent of CD8+ expressing CD38+HLA-DR+
-1.16
(-2.85 to 0.54)
-1.47
(-3.17 to 0.23)
-0.48
(-2.21 to 1.24)
13.Secondary Outcome
Title Change in Expression of PD-1+ on CD4+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percentage of CD4+ expressing PD-1+
-0.46
(-1.81 to 0.88)
-0.19
(-1.53 to 1.16)
-0.75
(-2.11 to 0.62)
14.Secondary Outcome
Title Change in Expression of PD-1+ on CD8+ From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 35 35 33
Mean (95% Confidence Interval)
Unit of Measure: percentage of CD8+ expressing PD-1+
-0.18
(-1.54 to 1.18)
-0.07
(-1.44 to 1.29)
-0.74
(-2.13 to 0.64)
15.Secondary Outcome
Title Change in IL-6 From Baseline to Week 11/12
Hide Description

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.

Time Frame Pre-entry and entry to weeks 11 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 38 36
Mean (95% Confidence Interval)
Unit of Measure: fold change
1.03
(0.87 to 1.21)
1.13
(0.96 to 1.33)
0.92
(0.78 to 1.09)
16.Secondary Outcome
Title Change in D-dimer From Baseline to Week 11/12
Hide Description

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.

Time Frame Pre-entry and entry to weeks 11 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 38 35
Mean (95% Confidence Interval)
Unit of Measure: fold change
1.08
(0.97 to 1.19)
0.99
(0.89 to 1.10)
1.02
(0.91 to 1.13)
17.Secondary Outcome
Title Change in Kynurenine to Tryptophan Ratio From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 37 35
Mean (95% Confidence Interval)
Unit of Measure: 1000 ng/ml kynurenine : ng/ml tryptophan
0.45
(-1.78 to 2.69)
-2.60
(-4.90 to -0.30)
-1.26
(-3.59 to 1.07)
18.Secondary Outcome
Title Change in Serum Thromboxane B2 From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 36 33
Mean (95% Confidence Interval)
Unit of Measure: fold change
0.28
(0.20 to 0.38)
0.20
(0.15 to 0.28)
1.21
(0.86 to 1.69)
19.Secondary Outcome
Title Change in Urine Thromboxane Per Creatinine From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 38 37 33
Mean (95% Confidence Interval)
Unit of Measure: fold change
0.25
(0.19 to 0.32)
0.23
(0.18 to 0.30)
0.96
(0.71 to 1.30)
20.Secondary Outcome
Title Change in Brachial Artery Flow-mediated Dilation (FMD) From Entry to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at entry.
Time Frame Entry to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used the per-protocol population as in the primary analyses.
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 34 33 32
Mean (95% Confidence Interval)
Unit of Measure: percentage of brachial artery diameter
-0.32
(-1.17 to 0.54)
-0.98
(-1.85 to -0.11)
-0.20
(-1.08 to 0.69)
Time Frame From baseline to Week 16.
Adverse Event Reporting Description 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.
 
Arm/Group Title Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/41 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/41 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin 300 mg + Aspirin 100 mg Placebo Aspirin 100 mg + Aspirin 300 mg Placebo Aspirin 300 mg + Aspirin 100 mg Placebos
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   1/41 (2.44%)   6/40 (15.00%) 
Infections and infestations       
Acute sinusitis  1  0/40 (0.00%)  0/41 (0.00%)  2/40 (5.00%) 
Investigations       
Neutrophil count decreased  1  0/40 (0.00%)  1/41 (2.44%)  4/40 (10.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02155985     History of Changes
Other Study ID Numbers: ACTG A5331
UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: June 3, 2014
First Posted: June 4, 2014
Results First Submitted: May 27, 2016
Results First Posted: July 7, 2016
Last Update Posted: June 12, 2017