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Aspirin and Antiretroviral Therapy in HIV Infected Patients

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00783614
First received: October 31, 2008
Last updated: October 3, 2012
Last verified: October 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

  • Blood Markers of Inflammation, Endothelial Injury, and Thrombosis [ Time Frame: changes from baseline to 6 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Placebo Comparator: 2
Start 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 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783614

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

No publications provided by Minneapolis Medical Research Foundation

Additional 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, 5 T32 GM12453-03
Study First Received: October 31, 2008
Results First Received: January 16, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014