Aspirin and Antiretroviral Therapy in HIV Infected Patients

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00783614
• Other study ID #: PCC-002
• Status: Terminated
• Phase: Phase 2
• First received: October 31, 2008
• Last updated: October 19, 2017
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2017
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Aspirin 325mg
Patients randomized to Aspirin 325mg po daily versus placebo pill daily
• Antiretroviral therapy (ART)
Patients randomized to start ART immediately or defer use for 1 month

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Blood Markers of Inflammation, Endothelial Injury, and Thrombosis		changes from baseline to 6 months