Aspirin and Antiretroviral Therapy in HIV Infected Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Aspirin 325mg; Drug: Antiretroviral therapy (ART)

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily	Drug: Aspirin 325mg; Patients randomized to Aspirin 325mg po daily versus placebo pill daily; Drug: Antiretroviral therapy (ART); Patients randomized to start ART immediately or defer use for 1 month
Placebo Comparator: 2; Start antiretroviral therapy (ART) immediately and initiate placebo pill daily	Drug: Antiretroviral therapy (ART); Patients randomized to start ART immediately or defer use for 1 month
Active Comparator: 3; Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily	Drug: Aspirin 325mg; Patients randomized to Aspirin 325mg po daily versus placebo pill daily; Drug: Antiretroviral therapy (ART); Patients randomized to start ART immediately or defer use for 1 month
Placebo Comparator: 4; Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily	Drug: Antiretroviral therapy (ART); Patients randomized to start ART immediately or defer use for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis		changes from baseline to 6 months

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Investigators: Principal Investigator: Jason V Baker, MD, MS, University of Minnesota; HCMC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 31, 2008
• First Submitted That Met QC Criteria: October 31, 2008
• First Posted (Estimate): November 2, 2008

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Cardiovascular Disease; Endothelial Dysfunction
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Anti-Retroviral Agents
• Other Study ID Numbers: PCC-002