HIV Infection
Conditions
Keywords
HIV, Cardiovascular Disease, Endothelial Dysfunction
Brief summary
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.
Detailed description
Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.
Interventions
DRUGAspirin 325mg
Patients randomized to Aspirin 325mg po daily versus placebo pill daily
Patients randomized to start ART immediately or defer use for 1 month
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. HIV-infected (by positive HIV Ab or detectable HIV RNA level) 2. No ART for at least previous 3 months 3. Ready to start or re-start ART (regimen pre-chosen by patient and provider)
Exclusion criteria
1. Age \< 18 years, or \>60 years 2. Pregnancy 3. Current aspirin use 4. Presence of known atherosclerotic CVD determined by: 1. Previous myocardial infarction 2. Significant coronary atherosclerosis by angiography 3. Coronary revascularization procedure (coronary stent or surgical bypass) 4. Previous cerebral vascular accident (stroke) 5. Ischemic cardiomyopathy 6. Carotid stenosis (\>25% narrowing by carotid ultrasound) 7. Aortic aneurysm 8. Symptomatic peripheral vascular disease (claudication) 9. Surgical revascularization procedure of peripheral vessels 5. Hospitalization (within prior 2 weeks of study entry) 6. Concurrent self-limited bacterial infections (does not include chronic viral infections) 7. Clinical or pathologic diagnosis of systemic vasculitis 8. Active drug or alcohol use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events | 6 months | 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 |
| Blood Markers of Inflammation, Endothelial Injury, and Thrombosis | changes from baseline to 6 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ART and Aspirin Start ART immediately and initiate aspirin 325mg po daily | 6 |
| ART and Placebo Start ART immediately and initiate placebo pill daily | 6 |
| Defer and Aspirin Defer ART for 1 month and immediately initiate aspirin 325mg po daily | 5 |
| Defer and Placebo Defer ART for 1 month and immediately initiate placebo pill daily | 5 |
| Total | 22 |
Baseline characteristics
| Characteristic | ART and Placebo | Defer and Aspirin | ART and Aspirin | Defer and Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 22 Participants |
| Age, Continuous | 38.4 years STANDARD_DEVIATION 10.6 | 36.0 years STANDARD_DEVIATION 9.3 | 36.7 years STANDARD_DEVIATION 9 | 37.5 years STANDARD_DEVIATION 11.1 | 37.6 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 6 participants | 5 participants | 6 participants | 5 participants | 22 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 6 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
Time frame: changes from baseline to 6 months
Population: Data measurements not obtained, as study terminated early due to poor enrollment
Primary
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events
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
Time frame: 6 months
Population: The number of participants with adverse events or reporting side effects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART and Aspirin | Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events | 1 participants |
| ART and Placebo | Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events | 0 participants |
| Defer and Aspirin | Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events | 1 participants |
| Defer and Placebo | Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events | 0 participants |