Since people started taking HIV medications, illness from AIDS has decreased, but other
serious diseases like heart disease, cancer, and kidney, and liver disease have increased.
HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured
by blood. Inflammation can lead to diseases that have become some of the leading causes of
death in people with HIV. HIV therapy can partially lower levels of inflammation measured in
blood, however, levels of inflammation in people who have HIV may remain high compared with
people not infected with HIV.
Aspirin is a drug that is commonly used for pain relief but is also approved by the Food and
Drug Administration (FDA) for preventing heart attacks and stroke in those who are at
increased risk for heart attack and stroke. Aspirin also is used (but is not approved by the
FDA) to decrease the risk of some cancers in people who are at increased risk. Aspirin is
thought to decrease risk of heart attack and stroke because it blocks the activation of
platelets and prevents blood clots from clogging narrowed blood vessels, a disease called
atherosclerosis. It is unknown how aspirin might decrease the chance of developing cancer in
some people at higher risk, but aspirin has been shown to modulate (or change) the immune
system. In HIV-infected people who have been taking antiretroviral therapy and have an
undetectable HIV viral load it was recently shown that low-dose aspirin 81 mg (baby aspirin),
given for one week, lowers platelet activation and reduces blood markers of inflammation
which may improve the function of the immune system.
The purpose of this study was to evaluate whether aspirin improves inflammation and immune
activation when compared to a placebo (inactive medication like a dummy pill) and to
determine if 12 weeks of aspirin 300 mg and aspirin 100 mg is safe for HIV-infected persons
on antiretroviral therapy. Additionally, it studied whether a higher dose and longer duration
of aspirin provides further anti-inflammatory and immune-modulating benefit. This was done
using blood and urine tests that measure inflammation and also with a test that uses
ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation (FMD)
of the brachial artery (BART). This is a painless test that bounces sound waves off of a
blood vessel in your arm.
Phase:
Phase 2
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)