Aspirin and Antiretroviral Therapy in HIV Infected Patients

Phase 2TerminatedNCT00783614

Hennepin Healthcare Research Institute22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

HIV Infection

Interventions

Aspirin 325mgDRUG

Patients randomized to Aspirin 325mg po daily versus placebo pill daily

Antiretroviral therapy (ART)DRUG

Patients randomized to start ART immediately or defer use for 1 month

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Blood Markers of Inflammation, Endothelial Injury, and Thrombosis

Time frame: changes from baseline to 6 months

Data from ClinicalTrials.gov

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