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.
- 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.
There are 6 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
- Clonal hematopoiesis of indeterminate potential, incident cardiovascular outcomes
- Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
The Mechanistic Substudy of REPRIEVE (ACTG A5333s) is trying to understand ways in which statin therapy may achieve this goal. Some possible ways include:
- lowering cholesterol levels
- lowering the degree of inflammation
- stabilizing fatty plaques in the blood vessels surrounding the heart, preventing these plaques from rupturing.
805 participants enrolled in the REPRIEVE substudy and the last visit was completed summer of 2020. Substudy participants had some additional tests and monitoring, including CT scan 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 clinical and subclinical kidney function and to investigate the relationship between CKD and CVD.
Clonal Hematopoiesis of Indeterminate Potential, Incident Cardiovascular Outcomes
The objective is to estimate the prevalence of & characterize risk factors for CHIP in PWH, associate CHIP w/ incident clinical outcomes in PWH, and discover mechanistic relationships of CHIP w/ HIV-associated outcomes.
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
The objective is to characterize the epidemiology and pathobiology of COVID, especially regarding CVD and PWH, identify host factors influencing risk with respect to COVID and related CV outcomes, and determine whether statin therapy protects against COVID and/or mitigates severity.