The REPRIEVE (A5332) trial is the first-ever, large scale clinical trial to test a strategy to prevent heart disease among people living with HIV. Participants in this trial will be contributing meaningfully to the pursuit of new medical knowledge.
- What is the purpose of the REPRIEVE trial?
- What are statins?
- How will this trial work?
- How many people will participate in the REPRIEVE trial?
- How long will it take to finish the REPRIEVE trial?
- Where will the REPRIEVE trial be conducted?
- Is there a substudy as part of the REPRIEVE trial?
- Who funds the REPRIEVE trial?
1. What is the purpose of the REPRIEVE trial?
Previous studies have shown that HIV-infected individuals are at higher risk for heart disease than individuals without HIV. The REPRIEVE trial is testing a strategy to reduce the risk of heart disease –including heart attack and stroke – among people living with HIV. In people with HIV, cardiovascular disease risk is thought to be influenced by traditional risk factors – such as cigarette smoking, high blood pressure, diabetes, and high cholesterol – and also by factors unique to HIV, such as chronic inflammation.
2. What are statins?
Statins are medications that lower cholesterol levels in the blood, and have also been shown to have anti-inflammatory effects. Statins have already been shown to reduce the risk of heart disease in the general population among individuals at high risk for heart disease based on traditional risk factors. At the conclusion of REPRIEVE, we will know whether statins reduce the risk of heart disease among HIV-infected individuals with low to moderate traditional risk scores.
3. How will this trial work?
Participants were randomized (like flipping a coin) to take either:
- Pitavastatin Calcium (Livalo) 4 mg, one pill daily
- Placebo for Pitavastatin Calcium (Livalo), one pill daily
Pitavastatin Calcium (Livalo) is a statin that has been approved by the US Food and Drug Administration for the treatment of high cholesterol, even though not all participants in the trial have high levels of cholesterol, as per the trial design. Advice on healthy diet and exercise is given to all participants in the trial. Pitavastatin Calcium (Livalo) has been shown to be safe in individuals taking antiretroviral (ART) medications.
4. How many people are participating in the REPRIEVE trial?
REPRIEVE has enrolled over 7500 people with HIV into the trial.
5. How long will it take to finish the REPRIEVE trial?
Participants have visits approximately every 4 months during the trial. Trial participation for individual participants will be on average 6 years.
6. Where is the REPRIEVE trial being conducted?
The REPRIEVE trial is being conducted primarily at research sites in United States, Canada, Thailand, South Africa, Brazil, Peru, Haiti, and India. Over 100 research sites enrolled participants into REPRIEVE. A map is posted providing links to participating sites, as well as contact information for the participating sites.
7. Are there any substudies that are a part of the REPRIEVE trial?
There are 4 substudies that are part of the REPRIEVE trial, including 2 additional study objectives included in REPRIEVE, they are:
- The REPRIEVE Mechanistic Substudy (ACTG A5333s)
- Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE) (ACTG #A5361s)
- Sex-Specific Mechanisms of Cardiovascular Disease Risk and Risk Reduction
- Evaluate the Effect of Pitavastatin on Kidney Function in HIV-infected Persons
The Mechanistic Substudy of REPRIEVE (ACTG A5333s) is trying to understand ways in which statin therapy may achieve this goal. Some possible ways include:
1) lowering cholesterol levels
2) lowering the degree of inflammation
3) stabilizing fatty plaques in the blood vessels surrounding the heart, preventing these plaques from rupturing.
800 REPRIEVE participants are participating in the REPRIEVE substudy. Substudy participants undergo some additional tests and monitoring, including CT scans of the heart’s blood vessels.
PREPARE is an observational study of muscle strength and function among HIV-infected adults who are receiving pitavastatin or placebo as part of the REPRIEVE study (A5332) and are also enrolled in the Mechanistic substudy (A5333s). 600 REPRIEVE participants are also participating in the PREPARE substudy.
Sex-Specific Mechanisms of Cardiovascular Disease Risk and Risk Reduction
This objective is exploring among participants in REPRIEVE, differences in immune activation in relation to heart disease events. Another important part of this objective is to assure increased participation among women in REPRIEVE.
Evaluation of the Effects of Pitavastatin on Kidney Function in HIV-infected Persons
To evaluate the effects of pitavastatin on clinically relevant parameters of kidney function among REPRIEVE participants.
8. Who funds the REPRIEVE trial?
REPRIEVE is funded by the National Heart Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH), with significant support and collaboration from the National Institute of Allergy and Infectious Diseases (NIAID) through its Division of AIDS (DAIDS). In addition, Kowa Pharmaceuticals America, Inc. is donating pitavastatin and providing support for the study.
The REPRIEVE trial is a collaboration of government agencies, academic centers, research institutes and industry support working in partnership to determine if pitavastatin can reduce the risk of cardiovascular disease in people with HIV infection who are taking HIV medications.