Trial Outcomes & Findings for Aspirin and Antiretroviral Therapy in HIV Infected Patients (NCT NCT00783614)

Results Overview

At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

6 months

Results posted on

2017-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	ART and Aspirin Start ART immediately and initiate aspirin 325mg po daily	ART and Placebo Start ART immediately and initiate placebo pill daily	Defer and Aspirin Defer ART for 1 month and immediately initiate aspirin 325mg po daily	Defer and Placebo Defer ART for 1 month and immediately initiate placebo pill daily
Overall Study STARTED	6	6	5	5
Overall Study COMPLETED	6	6	5	5
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin and Antiretroviral Therapy in HIV Infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ART and Placebo n=6 Participants Start ART immediately and initiate placebo pill daily	Defer and Aspirin n=5 Participants Defer ART for 1 month and immediately initiate aspirin 325mg po daily	Defer and Placebo n=5 Participants Defer ART for 1 month and immediately initiate placebo pill daily	ART and Aspirin n=6 Participants Start ART immediately and initiate aspirin 325mg po daily	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=5 Participants	22 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=21 Participants
Age, Continuous	38.4 years STANDARD_DEVIATION 10.6 • n=7 Participants	36.0 years STANDARD_DEVIATION 9.3 • n=5 Participants	37.5 years STANDARD_DEVIATION 11.1 • n=4 Participants	36.7 years STANDARD_DEVIATION 9.0 • n=5 Participants	37.6 years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=5 Participants	4 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=5 Participants	18 Participants n=21 Participants
Region of Enrollment United States	6 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	6 participants n=5 Participants	22 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The number of participants with adverse events or reporting side effects

At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication

Outcome measures

Outcome measures
Measure	ART and Aspirin n=6 Participants Start ART immediately and initiate aspirin 325mg po daily	ART and Placebo n=6 Participants Start ART immediately and initiate placebo pill daily	Defer and Aspirin n=5 Participants Defer ART for 1 month and immediately initiate aspirin 325mg po daily	Defer and Placebo n=5 Participants Defer ART for 1 month and immediately initiate placebo pill daily
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events	1 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: changes from baseline to 6 months

Population: Data measurements not obtained, as study terminated early due to poor enrollment

Outcome measures

Outcome data not reported

Adverse Events

ART and Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ART and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Defer and Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Defer and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Baker

Minneapolis Medical Foundation

Phone: 612-873-2705

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place