CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Aspirin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02081638
NCT02081638Phase 2Completed

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 7, 2014·Updated Dec 29, 2020

In Brief

A Phase 2 clinical trial evaluating Aspirin and Atorvastatin for Human Immunodeficiency Virus. Completed, enrolled 53 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 7, 2014
Enrollment StartApr 18, 2014
Primary CompletionOct 16, 2019
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 12.3 years ago

Interventions

Aspirindrug

Daily Asprin daily

Atorvastatindrug

Daily Atorvastatin Daily