Aspirin and Antiretroviral Therapy in HIV Infected Patients

Hennepin Healthcare

Status and phase: Terminated; Phase 2

Conditions: HIV Infection

Treatments: Drug: Antiretroviral therapy (ART); Drug: Aspirin 325mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00783614

PCC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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22 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily

Treatment:

Drug: Antiretroviral therapy (ART)

Drug: Aspirin 325mg

2

Placebo Comparator group

Description:

Start antiretroviral therapy (ART) immediately and initiate placebo pill daily

Treatment:

Drug: Antiretroviral therapy (ART)

3

Active Comparator group

Description:

Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily

Treatment:

Drug: Antiretroviral therapy (ART)

Drug: Aspirin 325mg

4

Placebo Comparator group

Description:

Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily

Treatment:

Drug: Antiretroviral therapy (ART)