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NCT02081638 · ClinicalTrials.gov registry record · Phase 2

Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention Study

A Phase 2 study of Human Immunodeficiency Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
53
Enrollment target
2
Study locations

NCT02081638 is a Phase 2 study of Human Immunodeficiency Virus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 53 participants, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT02081638, a Phase 2 study of Human Immunodeficiency Virus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target
2
Study locations

Study Summary

Background: \- The immune system protects the body from infection. But it can also cause harm. For example, the clotting system makes blood clot and protects from bleeding. But blood clots are sometimes harmful. People with human immunodeficiency virus (HIV) infection have increased inflammation and clotting. This may increase their risk for diseases like stroke or heart attack. Researchers want to know how aspirin or HMG-CoA reductase inhibitors (so-called statin medications) affect the immune and clotting systems of people with HIV. Aspirin is a medicine to decrease clotting. Statins are medications given to lower cholesterol and decrease inflammation. Objectives: \- To see how aspirin or statins change immune and clotting systems in people with HIV. Eligibility: \- Adults 18 and older with HIV and a low viral load, not on aspirin or a statin medication. They must also have either: (1) never taken anti-HIV medications (ARVs), have a suppressed viral load, have stable CD4 counts, and never had an opportunistic infection; or (2) been taking ARVs for 5 continuous years and have a suppressed viral load for more than 3 years. Design: * Participants will be screened with medical history, physical exam, and blood and lab tests. * Participants will repeat screening tests and have an MRI. An MRI is a way to visualize blood vessels in the neck and head. Participants will lie on a table that slides in and out of a cylinder surrounded by a magnetic field. * Participants will take either study drug once daily for 9 months. * Participants will have a blood procedure twice. Blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The blood, minus white blood cells, is returned through a needle in the other arm. * All participants will be observed for 3 months before and after treatment.

Conditions Studied

Human Immunodeficiency Virus

Interventions

  • DRUG Aspirin
  • DRUG Atorvastatin

Study Locations (2)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Minnesota

  • Hennipen County Medical Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2014-04-18
Est. Completion 2019-10-16
Phase Phase 2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT02081638

The ClinicalTrials.gov registry entry for NCT02081638 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (71% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 2 interventions - of which Aspirin is the first listed.

NCT02081638 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Minnesota.

Frequently Asked Questions

What is clinical trial NCT02081638 about?

NCT02081638 is a clinical study titled "Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention Study". Background: \- The immune system protects the body from infection. But it can also cause harm. For example, the clotting system makes blood clot and protects from bleeding. But blood clots are sometimes harmful. People with human immunodeficiency virus (HIV) infection have increased inflammation an...

What is the current status of trial NCT02081638?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2014-04-18. Estimated completion is 2019-10-16.

What conditions does trial NCT02081638 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus.

What interventions are being tested in trial NCT02081638?

The interventions under investigation include: Aspirin (DRUG), Atorvastatin (DRUG).

Who is sponsoring clinical trial NCT02081638?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02081638 being conducted?

This trial has 2 study locations across Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.