Overview

Aspirin and Antiretroviral Therapy in HIV Infected Patients

Status:
Terminated

Trial end date:
2010-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hennepin Healthcare Research Institute
Minneapolis Medical Research Foundation

Collaborators:

National Institutes of Health (NIH)
University of Minnesota - Clinical and Translational Science Institute

Treatments:

Anti-Retroviral Agents
Aspirin

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