Aspirin and Antiretroviral Therapy in HIV Infected Patients

NCT ID: NCT00783614

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-06-30

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1

Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily

Group Type: ACTIVE_COMPARATOR

Aspirin 325mg

Intervention Type: DRUG

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

Antiretroviral therapy (ART)

Intervention Type: DRUG

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

2

Start antiretroviral therapy (ART) immediately and initiate placebo pill daily

Group Type: PLACEBO_COMPARATOR

Antiretroviral therapy (ART)

Intervention Type: DRUG

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

3

Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily

Group Type: ACTIVE_COMPARATOR

Aspirin 325mg

Intervention Type: DRUG

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

Antiretroviral therapy (ART)

Intervention Type: DRUG

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

4

Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily

Group Type: PLACEBO_COMPARATOR

Antiretroviral therapy (ART)

Intervention Type: DRUG

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

Interventions

Aspirin 325mg

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

Intervention Type: DRUG

Antiretroviral therapy (ART)

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason V Baker, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota; HCMC

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21951596 (View on PubMed)

Other Identifiers

PCC-002

Identifier Type: -

Identifier Source: org_study_id