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Aspirin and Antiretroviral Therapy in HIV Infected Patients

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ClinicalTrials.gov Identifier: NCT00783614
Recruitment Status : Terminated (Lack of funding)
First Posted : November 3, 2008
Results First Posted : April 17, 2012
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Aspirin 325mg Drug: Antiretroviral therapy (ART) Phase 2

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study
Study Start Date : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events [ Time Frame: 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

  2. Blood Markers of Inflammation, Endothelial Injury, and Thrombosis [ Time Frame: changes from baseline to 6 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783614


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: Jason V Baker, MD, MS University of Minnesota; HCMC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00783614     History of Changes
Other Study ID Numbers: PCC-002
First Posted: November 3, 2008    Key Record Dates
Results First Posted: April 17, 2012
Last Update Posted: November 21, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics