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Trial record 44 of 217 for:    heart disease AND stroke AND California

Modulation of Immune Activation by Aspirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first participant enrolled on August 18, 2014. The last participant enrolled on March 6, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Aspirin 300 mg + Aspirin 100 mg Placebo   Aspirin 100 mg + Aspirin 300 mg Placebo   Aspirin 300 mg + Aspirin 100 mg Placebos
STARTED   40   41   40 
COMPLETED   39   41   39 
NOT COMPLETED   1   0   1 
Withdrawal by Subject                0                0                1 
Lost to Follow-up                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
121 randomized participants, all of which did initiate study treatment.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Aspirin 300 mg + Aspirin 100 mg Placebo   Aspirin 100 mg + Aspirin 300 mg Placebo   Aspirin 300 mg + Aspirin 100 mg Placebos   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   41   40   121 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 48 
 (38 to 54) 
 50 
 (46 to 56) 
 49 
 (42 to 57) 
 49 
 (42 to 55) 
Age, Customized 
[Units: 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 
[Units: Participants]
Count of 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 
[Units: 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 
[Units: Participants]
       
United States   40   41   40   121 
Smoking Status 
[Units: Participants]
       
Never   19   25   26   70 
Previously   11   7   6   24 
Currently   10   9   8   27 
Statin Use 
[Units: Participants]
       
Off Statins   33   35   34   102 
Pravastatin   3   0   3   6 
Atorvastatin   3   5   3   11 
Rosuvastatin   1   1   0   2 
BMI, Continuous 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 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 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 573 
 (436 to 684) 
 629 
 (481 to 856) 
 642 
 (436 to 747) 
 599 
 (456 to 777) 
HIV-1 RNA, Categorical 
[Units: 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 
[Units: 10^9/L]
Median (Inter-Quartile Range)
 222.5 
 (192 to 251) 
 229 
 (200 to 271) 
 224.5 
 (184 to 258.5) 
 226 
 (192 to 261) 
Hemoglobin, Continuous 
[Units: g/dL]
Median (Inter-Quartile Range)
 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) 


  Outcome Measures

1.  Primary:   Change in sCD14 From Baseline to Week 11/12   [ Time Frame: Pre-entry and entry to weeks 11 and 12 ]

2.  Secondary:   Safety   [ Time Frame: After study entry to Week 16 ]

3.  Secondary:   Tolerability   [ Time Frame: Treatment dispensation to Week 12 ]

4.  Secondary:   Change in sCD163 From Baseline to Week 11/12   [ Time Frame: Pre-entry and entry to weeks 11 and 12 ]

5.  Secondary:   Change in Expression of CD14dimCD16+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

6.  Secondary:   Change in Expression of CD69+ on CD14dimCD16+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

7.  Secondary:   Change in Expression of CD14+CD16- From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

8.  Secondary:   Change in Expression of CD69+ on CD14+CD16- From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

9.  Secondary:   Change in Expression of CD14+CD16+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

10.  Secondary:   Change in Expression of CD69+ on CD14+CD16+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

11.  Secondary:   Change in Expression of CD38+HLA-DR+ on CD4+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

12.  Secondary:   Change in Expression of CD38+HLA-DR+ on CD8+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

13.  Secondary:   Change in Expression of PD-1+ on CD4+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

14.  Secondary:   Change in Expression of PD-1+ on CD8+ From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

15.  Secondary:   Change in IL-6 From Baseline to Week 11/12   [ Time Frame: Pre-entry and entry to weeks 11 and 12 ]

16.  Secondary:   Change in D-dimer From Baseline to Week 11/12   [ Time Frame: Pre-entry and entry to weeks 11 and 12 ]

17.  Secondary:   Change in Kynurenine to Tryptophan Ratio From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

18.  Secondary:   Change in Serum Thromboxane B2 From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

19.  Secondary:   Change in Urine Thromboxane Per Creatinine From Entry to Week 12   [ Time Frame: Entry to Week 12 ]

20.  Secondary:   Change in Brachial Artery Flow-mediated Dilation (FMD) From Entry to Week 12   [ Time Frame: Entry to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: ACTGCT.Gov@s-3.com



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