What is the ECSTATIN Study?
People with HIV are at increased risk for non-infectious complications, including cardiovascular disease. The purpose of the ECSTATIN study is to see how aspirin (a medicine to decrease clotting) or statins (medications given to lower cholesterol and reduce inflammation) affect inflammation and clotting in people with HIV.
What does the study involve?
Volunteers will attend one screening visit to provide a medical history, complete a physical examination, and undergo laboratory tests to determine eligibility to participate in the study. Participants will then return to the study center 7 times over the course of 15 months to receive the study medication and/or undergo study-related tests and procedures.
Where is the study taking place?
Screening visits will take place at either the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, or the Hennepin County Medical Center in Minneapolis, Minnesota. All other study visits will take place at NIH. The NIH campus is accessible by car and public transportation.
Who can participate?
You may be eligible for the study if you
- Are HIV-positive and at least 18 years of age
- Are either an "elite controller" (a.k.a. "long term non-progressor") who is not taking HIV medications, with a stable CD4 count for the past five years and undetectable viral load OR a person who has taken HIV medications continuously for the past five years, with an undetectable viral load for the past three years or more
- Have not taken a statin or daily aspirin therapy for the past six months
- Have never been diagnosed with heart disease or high cholesterol
How much does it cost?
There is no charge to participate in this research study. All study-related medical care, including clinic visits and procedures, are provided free of charge.
Will I receive payment of some kind?
Yes, you will be compensated for your participation in the study. Transportation and other expenses may also be covered according to government travel rules.
How do I find out more or volunteer?
To learn more about this study (trial ID NCT02081638), visit ClinicalTrials.gov.