Aspirin and Antiretroviral Therapy in HIV Infected Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Aspirin 325mg
* Drug: Antiretroviral therapy (ART)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected (by positive HIV Ab or detectable HIV RNA level) No ART for at least previous 3 months Ready to start or re-start ART (regimen pre-chosen by patient and provider) Exclusion Criteria: Age < 18 years, or >60 years Pregnancy Current aspirin use Presence of known atherosclerotic CVD determined by: Previous myocardial infarction Significant coronary atherosclerosis by angiography Coronary revascularization procedure (coronary stent or surgical bypass) Previous cerebral vascular accident (stroke) Ischemic cardiomyopathy Carotid stenosis (>25% narrowing by carotid ultrasound) Aortic aneurysm Symptomatic peripheral vascular disease (claudication) Surgical revascularization procedure of peripheral vessels Hospitalization (within prior 2 weeks of study entry) Concurrent self-limited bacterial infections (does not include chronic viral infections) Clinical or pathologic diagnosis of systemic vasculitis Active drug or alcohol use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily | Drug: Aspirin 325mg<br>* Patients randomized to Aspirin 325mg po daily versus placebo pill daily<br>Drug: Antiretroviral therapy (ART)<br>* Patients randomized to start ART immediately or defer use for 1 month<br>|
| Placebo Comparator: 2<br>Start antiretroviral therapy (ART) immediately and initiate placebo pill daily | Drug: Antiretroviral therapy (ART)<br>* Patients randomized to start ART immediately or defer use for 1 month<br>|
| Active Comparator: 3<br>Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily | Drug: Aspirin 325mg<br>* Patients randomized to Aspirin 325mg po daily versus placebo pill daily<br>Drug: Antiretroviral therapy (ART)<br>* Patients randomized to start ART immediately or defer use for 1 month<br>|
| Placebo Comparator: 4<br>Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily | Drug: Antiretroviral therapy (ART)<br>* Patients randomized to start ART immediately or defer use for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Blood Markers of Inflammation, Endothelial Injury, and Thrombosis |  | changes from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Cardiovascular Disease, Endothelial Dysfunction