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Aspirin and Antiretroviral Therapy in HIV Infected Patients

Primary Purpose

HIV Infection

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin 325mg
Antiretroviral therapy (ART)
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV, Cardiovascular Disease, Endothelial Dysfunction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis

Secondary Outcome Measures

Full Information

First Posted
October 31, 2008
Last Updated
October 19, 2017
Sponsor
Hennepin Healthcare Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00783614
Brief Title
Aspirin and Antiretroviral Therapy in HIV Infected Patients
Official Title
The Effect of Aspirin and Antiretroviral Therapy on Cardiovascular Risk in HIV Infected Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, Cardiovascular Disease, Endothelial Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Start antiretroviral therapy (ART) immediately and initiate placebo pill daily
Arm Title
3
Arm Type
Active Comparator
Arm Description
Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily
Intervention Type
Drug
Intervention Name(s)
Aspirin 325mg
Intervention Description
Patients randomized to Aspirin 325mg po daily versus placebo pill daily
Intervention Type
Drug
Intervention Name(s)
Antiretroviral therapy (ART)
Intervention Description
Patients randomized to start ART immediately or defer use for 1 month
Primary Outcome Measure Information:
Title
Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events
Description
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
Time Frame
6 months
Title
Blood Markers of Inflammation, Endothelial Injury, and Thrombosis
Time Frame
changes from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected (by positive HIV Ab or detectable HIV RNA level) No ART for at least previous 3 months Ready to start or re-start ART (regimen pre-chosen by patient and provider) Exclusion Criteria: Age < 18 years, or >60 years Pregnancy Current aspirin use Presence of known atherosclerotic CVD determined by: Previous myocardial infarction Significant coronary atherosclerosis by angiography Coronary revascularization procedure (coronary stent or surgical bypass) Previous cerebral vascular accident (stroke) Ischemic cardiomyopathy Carotid stenosis (>25% narrowing by carotid ultrasound) Aortic aneurysm Symptomatic peripheral vascular disease (claudication) Surgical revascularization procedure of peripheral vessels Hospitalization (within prior 2 weeks of study entry) Concurrent self-limited bacterial infections (does not include chronic viral infections) Clinical or pathologic diagnosis of systemic vasculitis Active drug or alcohol use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason V Baker, MD, MS
Organizational Affiliation
University of Minnesota; HCMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21951596
Citation
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.
Results Reference
derived

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Aspirin and Antiretroviral Therapy in HIV Infected Patients

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