Aspirin and Antiretroviral Therapy in HIV Infected Patients

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.

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