Clinical trial NCT00783614: Aspirin and Antiretroviral Therapy in HIV Infected Patients
Official title: The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infection
Keywords: HIV
Cardiovascular Disease
Endothelial Dysfunction
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events
timeFrame: 6 months
measure: Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
timeFrame: changes from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota; HCMC
name: Jason V Baker, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x. No abstract available.