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?
- Who can participate in REPRIEVE?
- 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?
- How can I learn more about the REPRIEVE trial?
- 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 will test a strategy to reduce the risk of heart disease –including heart attack and stroke – among people living with HIV. Among HIV-infected individuals, 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. Who can participate in REPRIEVE?
You may be eligible if you are:
- HIV positive and between the ages of 40 and 75
- On antiretroviral therapy (ART) for at least 6 months prior to study entry
- No history of heart disease (including heart attack or stroke)
- Must not be currently using a statin drug
- Low to moderate risk for developing heart disease
4. How will this trial work?
Participants will be randomized (like flipping a coin) to take either:
- Pitavastatin 4 mg, one pill daily
- Placebo for pitavastatin, one pill daily
Pitavastatin 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 will have high levels of cholesterol, as per the trial design. Advice on healthy diet and exercise will be given to all participants in the trial. Pitavastatin has been shown to be safe in individuals taking antiretroviral (ART) medications.
5. How many people will participate in the REPRIEVE trial?
The REPRIEVE trial expects to enroll 6500 participants into the trial.
6. How long will it take to finish the REPRIEVE trial?
Participants will have visits approximately every 4 months during the trial. Trial participation for individual participants will be on average 4 years.
7. Where will the REPRIEVE trial be conducted?
The REPRIEVE trial will be conducted primarily at research sites in United States, Canada, Thailand, South Africa, Brazil, Peru, Haiti, and India. Over 100 research sites are currently enrolling participants. A map is posted providing links to participating sites, as well as contact information for the participating sites.
8. How can I learn more about the REPRIEVE trial?
More information regarding REPRIEVE can be found on the ClinicalTrials.gov website. See the map of sites which includes contact information for sites recruiting, or call 1-877-29-HEART (1-877-29-43278).
9. Are there any substudies that are a part of the REPRIEVE trial?
There are 2 substudies enrolling REPRIEVE participants and 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) will try 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 will also participate in the REPRIEVE substudy. Substudy participants will 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 will also participate in the PREPARE substudy.
Sex-Specific Mechanisms of Cardiovascular Disease Risk and Risk Reduction
This objective will explore 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, click here to read more on heart disease among women living with HIV.
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.
10. 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.