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Clinical trialNCT02155985CompletedPhase 2Interventional

Modulation of Immune Activation by Aspirin

SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsEnrollment121HIV-1 Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 601 University of California, Los Angeles Care Center Crs

    Los Angeles, California, United States

  • 701 University of California, San Diego Antiviral Research Center Crs

    San Diego, California, United States

  • Ucsf Aids Crs (801)

    San Francisco, California, United States

  • Harbor-Ucla Med. Ctr. Crs (603)

    Torrance, California, United States

  • University of Colorado Hospital Crs (6101)

    Aurora, Colorado, United States

  • 2701 Northwestern University Crs

    Chicago, Illinois, United States

  • Rush Univ. Med. Ctr. Actg Crs (2702)

    Chicago, Illinois, United States

  • Brigham and Women'S Hosp. Actg Crs (107)

    Boston, Massachusetts, United States

  • Massachusetts General Hospital Actg Crs (101)

    Boston, Massachusetts, United States

  • 3201 Chapel Hill Crs

    Chapel Hill, North Carolina, United States

  • Greensboro Crs (3203)

    Greensboro, North Carolina, United States

  • Univ. of Cincinnati Crs (2401)

    Cincinnati, Ohio, United States

  • Case Crs (2501)

    Cleveland, Ohio, United States

  • 3652 Vanderbilt Therapeutics (vt) Crs

    Nashville, Tennessee, United States

  • Houston Aids Research Team Crs (31473)

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2014
Primary completion
30 Jun 2015
Completion
31 Jul 2015
Last update posted
12 Jun 2017
Registered enrollment
121
Registry id
NCT02155985

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.