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Aspirin and Antiretroviral Therapy in HIV Infected Patients
This study is currently recruiting participants.
Verified by Minneapolis Medical Research Foundation, October 2008
Sponsors and Collaborators: Minneapolis Medical Research Foundation
University of Minnesota
National Institutes of Health (NIH)
Information provided by: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00783614
  Purpose

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.


Condition Intervention Phase
HIV Infection
 Drug: Aspirin 325mg
Drug: Antiretroviral therapy (ART)
 Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Acetylsalicylic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study

Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Large and Small Arterial Elasticity (LAE and SAE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood markers of inflammation, endothelial injury, and thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Start 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
2: Placebo Comparator
Start ART immediately and initiate placebo pill daily
Drug: Antiretroviral therapy (ART)
Patients randomized to start ART immediately or defer use for 1 month
3: Active Comparator
Defer 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
4: Placebo Comparator
Defer 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783614

Contacts
Contact: PCC Research 612-873-2297
Contact: Rachel Prosser, NP 612-873-2877 Rachel.Prosser@hcmed.org

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: PCC Research     612-873-2297        
Contact: Rachel Prosser, NP     612-873-2877     rachel.prosser@hcmed.org    
Principal Investigator: Jason V Baker, MD, MS            
Sub-Investigator: Keith Henry, MD            
Sponsors and Collaborators
Minneapolis Medical Research Foundation
University of Minnesota
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jason V Baker, MD, MS University of Minnesota; HCMC
  More Information

Responsible Party: MMRF ( Jason Baker )
Study ID Numbers: PCC-002, 5 T32 GM12453-03
Study First Received: October 31, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00783614  
Health Authority: United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:
HIV
Cardiovascular Disease
Endothelial Dysfunction

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Aspirin
HIV Infections
 Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Inflammatory Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Infection
 Pharmacologic Actions
Fibrin Modulating Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009



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