Study Name
Elite Controller and ART-Treated HIV+ Statin versus ASA Treatment Intervention Study
Study Number
14-I-0039
Goal of Study
The National Institutes of Health (NIH) is conducting a study that will look at changes in the body’s immune and clotting system markers. The immune system is made up of cells and substances that protect the body from infection and foreign matter. The activation of the immune system (or inflammation) can sometimes be harmful. Similarly, the clotting system is what makes the blood clot and protects us from bleeding but can be sometimes harmful if it is inappropriately activated. In chronic HIV infection, there is increased inflammation and coagulation (clotting) that may put people at higher risk for cardiovascular diseases such as stroke or heart attacks. Our goal is to study how immune and clotting system markers may change in people infected with HIV after receiving nine months of a daily dose of aspirin (a medication that decreases clotting and inflammation) or atorvastatin (a medication which lowers blood cholesterol and decreases inflammation). As part of the study we will also examine your carotid vessels (the major blood vessels that supply blood to the neck and head) by magnetic tomography to look at the thickness of the vessel wall.
Study Regimen
A total of 80 people will be enrolled in the study. There will be 40 volunteers in each category. Half of the volunteers in each category will be randomized (process similar to the toss of the coin) to either a once daily dose of aspirin or a once daily dose of atorvastatin. Each group will receive nine months of the medication. Volunteers in each group will have a three-month observation period before and after treatment. The total duration of the study for each volunteer will be 15 months. Volunteers will be compensated.
Eligibility Criteria
- 18 years or older with documented HIV infection
- Either an "elite controller" (a.k.a. "long term non-progressor") who has never taken 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 four years, with an undetectable viral load for the past three years or more
- Not pregnant, breast-feeding, or plan to get pregnant in the near future
- Never been diagnosed with heart disease or high cholesterol
- Has not taken a statin or daily aspirin therapy in the past six months
- Able to commit to about seven separate visits to NIH in a 15-month period
- Agrees to take either Lipitor or aspirin daily for nine months while on study (decision as to which medication PRV will be given will be at random)