Aspirin and Antiretroviral Therapy in HIV Infected Patients

Phase 2

Terminated

• Conditions: HIV Infection
• Interventions: Drug: Antiretroviral therapy (ART); Drug: Aspirin 325mg

• Registration Number: NCT00783614
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-31
• Study First Submitted QC: 2008-10-31
• Study First Posted: 2008-11-02
• Primary Completion: 2010-01
• Study Completion: 2010-06
• Results First Submitted: 2012-01-16
• Results First Submitted QC: 2012-03-23
• Results First Posted: 2012-04-17
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Antiretroviral therapy (ART)	Start antiretroviral therapy (ART) immediately and initiate placebo pill daily
3	Antiretroviral therapy (ART)	Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily
1	Antiretroviral therapy (ART)	Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily
3	Aspirin 325mg	Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily
4	Antiretroviral therapy (ART)	Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily
1	Aspirin 325mg	Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily

Primary Outcome Measures

Name	Time	Method
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis	changes from baseline to 6 months
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events	6 months	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

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States