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Lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily |
|
| 2 | Placebo Comparator | Start antiretroviral therapy (ART) immediately and initiate placebo pill daily |
|
| 3 | Active Comparator | Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily |
|
| 4 | Placebo Comparator | Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 325mg | Drug | Patients randomized to Aspirin 325mg po daily versus placebo pill daily |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Age < 18 years, or >60 years
Pregnancy
Current aspirin use
Presence of known atherosclerotic CVD determined by:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jason V Baker, MD, MS | University of Minnesota; HCMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21951596 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ART and Aspirin | Start ART immediately and initiate aspirin 325mg po daily |
| FG001 | ART and Placebo | Start ART immediately and initiate placebo pill daily |
| FG002 | Defer and Aspirin | Defer ART for 1 month and immediately initiate aspirin 325mg po daily |
| FG003 | Defer and Placebo | Defer ART for 1 month and immediately initiate placebo pill daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ART and Aspirin | Start ART immediately and initiate aspirin 325mg po daily |
| BG001 | ART and Placebo | Start ART immediately and initiate placebo pill daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The number of participants with adverse events or reporting side effects | Posted | Number | participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ART and Aspirin | Start ART immediately and initiate aspirin 325mg po daily |
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Early termination leading to small number of subjects analyzed. Study recruitment difficulty due to inclusion of ART deferral component.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Baker | Minneapolis Medical Foundation | 612-873-2705 | baker459@umn.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Antiretroviral therapy (ART) | Drug | Patients randomized to start ART immediately or defer use for 1 month |
|
| BG002 | Defer and Aspirin | Defer ART for 1 month and immediately initiate aspirin 325mg po daily |
| BG003 | Defer and Placebo | Defer ART for 1 month and immediately initiate placebo pill daily |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Defer and Aspirin | Defer ART for 1 month and immediately initiate aspirin 325mg po daily |
| OG003 | Defer and Placebo | Defer ART for 1 month and immediately initiate placebo pill daily |
|
|
| Primary | Blood Markers of Inflammation, Endothelial Injury, and Thrombosis | Data measurements not obtained, as study terminated early due to poor enrollment | Posted | changes from baseline to 6 months |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | ART and Placebo | Start ART immediately and initiate placebo pill daily | 0 | 6 | 0 | 6 |
| EG002 | Defer and Aspirin | Defer ART for 1 month and immediately initiate aspirin 325mg po daily | 0 | 5 | 0 | 5 |
| EG003 | Defer and Placebo | Defer ART for 1 month and immediately initiate placebo pill daily | 0 | 5 | 0 | 5 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |