Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention Study
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|ClinicalTrials.gov Identifier: NCT02081638|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2014
Last Update Posted : June 20, 2019
- 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.
- To see how aspirin or statins change immune and clotting systems in people with HIV.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: Aspirin Drug: Lipitor||Phase 2|
Despite dramatic improvements in mortality with antiretroviral therapy (ART), HIV-infected persons remain at risk of developing non-infectious complications, including cardiovascular, renal, and neurological disease. A small subset of the HIV-infected population achieve durable control of HIV virus in the absence of ART. These individuals, termed elite controllers (ECs), remain ART na(SqrRoot) ve, have stable CD4 T cell counts for many years and have no history of opportunistic infections. Despite the lack of AIDS complications, recent evidence suggests ECs may exhibit heightened immune activation that may contribute to a potentially increased risk for non-infectious complications, similar to successfully treated progressors.
In the current 2 group, randomized, open label trial, we intend to study the effects of a lipid lowering agent vs aspirin (ASA) on immune activation in HIV-1 infected participants. One group will consist of ECs who are HIV-1 infected, maintain HIV-RNA levels of less than the LLD of commercially available assays in the absence of ART, have no history of ART or opportunistic infections (OIs) and have stable CD4 T cell counts for greater than 3 years. The second group will enroll HIV-1 infected Treated Progressors (henceforth referred to as ART <50) who have maintained HIV-RNA below the limit of detection in commercially available assays (<40, <48, or <50 copies/mL) for greater than 3 years on ART (treatment duration greater than 4 years). Up to 2 months after the screening and enrollment visit, each group will enter a 3 month observation period (to establish baseline values for biomarkers/cellular markers). After 3 months, participants from each group will be randomized to either ASA, 81 mg PO daily, or atorvastatin (ATV), 40 mg (dose adjusted for subjects on antiretroviral regimens with significant interactions, and will be treated for 9 months, followed by 3 months of a wash out period (see Figure 1). The primary end point will be change of sCD14 after 9 months of study intervention from Month 3 to Month 12 in each treatment arm, with groups combined (EC and ART <50). Secondary objectives will be to compare changes in soluble biomarkers (sCD14, IL-6, D-dimer, hsCRP, sTF, sCD163 and other relevad treatment arms (ASA vs statin and EC vs ART<50 and with groups combined), to evaluate cardiovascular (CV) disease prevalence in EC vs ART<50 and with groups combined), to evaluate cardiovascular (CV) disease prevalence in EC vs ART <50 by MR imaging of carotids, to determine MR measurements and correlations with biomarkers and cellular activation markers, and to investigate changes in plasma viremia as measured by single copy assay over time.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Elite Controller and ART-Treated HIV+ Statin Versus ASA Treatment Intervention Study|
|Study Start Date :||March 5, 2014|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Active Comparator: Elite Controller
HIV infected off ART
Daily Asprin daily
Daily Lipitor daily
Active Comparator: Treated Progressors
HIV infected on ART
Daily Asprin daily
Daily Lipitor daily
- Changes in sCD14 after 9 months of treatment with aspirin or rosuvastatin, in Elite Controller and Treated Progressor (ART <50) groups combined. [ Time Frame: Month 12 ]sCD14 change
- Changes in soluble biomarkers including sCD14, IL-6, D- dimer, hsCRP, sTF, sCD163 and other related markers of inflammation and coagulation in EC and ART <50 groups treated with aspirin orrosuvastatin. [ Time Frame: Month 12 ]changes in multiple biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081638
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Minnesota|
|Hennipen County Medical Center|
|Minneapolis, Minnesota, United States|
|Principal Investigator:||Irini Sereti, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|