A5332: REPRIEVE Trial

HIV comorbidities and complications

In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.

HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured. Inflammation may contribute to diseases such as heart disease that have become some of the leading causes of death in people with HIV. HIV medications can lower inflammation somewhat, however sometimes the levels of inflammation can remain higher compared to people who do not have HIV.

Statins (name of the group of medicines that pitavastatin belongs to) are used to lower the levels of cholesterol and triglycerides (fat in the blood) that people make. Studies have shown that statins may have other benefits. For example, heart disease and the levels of inflammation can be lowered by statins.

Pitavastatin is a statin that, along with a diet, has been approved by the US Food and Drug Administration for the treatment of high cholesterol. It also lowers triglyceride levels in the blood.

The main purpose of this clinical trial is to see if pitavastatin can prevent heart disease and heart disease related deaths in people with HIV who are taking HIV medications.

The study coordinator will review all of the criteria necessary to be eligible for the study with you. Listed below are a few key points.

• Persons with HIV who are between the ages of 40 and 75.
• On antiretroviral therapy (ART, medicine to treat HIV) for at least 6 months prior to study entry.
• CD4+ cell count >100. (CD4 cells are a kind of white blood cell that are a measure of the immune system)
• Must not be pregnant or planning to become pregnant.
• No history of cardiovascular disease (history of heart attack or stroke, etc.).
• No history of cancer in the last year.
• Not currently using a statin drug.

Participants will be randomized (like flipping a coin) to take either:

• Pitavastatin 4 mg one pill daily with or without food or
• Placebo for pitavastatin one pill daily with or without food

You will be in this study for about 36 to 96 months depending on when you enroll in the study.