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NCT02155985 · ClinicalTrials.gov registry record · Phase 2
Modulation of Immune Activation by Aspirin
A Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
NCT02155985 is a Phase 2 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 121 participants.
The verdict
NCT02155985, a Phase 2 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
Study Summary
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 p
Interventions
- DRUG Placebo
- DRUG Aspirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02155985
The ClinicalTrials.gov registry entry for NCT02155985 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02155985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02155985 about?
NCT02155985 is a clinical study titled "Modulation of Immune Activation by Aspirin". 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 l...
What is the current status of trial NCT02155985?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2014-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02155985?
The interventions under investigation include: Placebo (DRUG), Aspirin (DRUG).
Who is sponsoring clinical trial NCT02155985?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
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