Comorbidities
Clinical Care and Management (CCM)
About The Study
REPRIEVE is the first large-scale randomized clinical research trial to test a strategy for heart disease prevention among people living with HIV. Specifically, REPRIEVE will test whether a daily dose of a statin (pitavastatin) reduces the risk of heart disease among people living with HIV.
The REPRIEVE trial will include 7,500 participants and will be conducted at approximately 100 clinical research sites, in the United States and abroad over a span of six years. In Canada, the REPRIEVE trial is aiming to recruit 550 participants from at least 7 sites.
About The Disease
AIDS-related complications and deaths are declining, while heart disease among people living with HIV is emerging as a major public health concern. This is happening despite effective treatment for HIV. People living with HIV are 50 to 100% more likely to develop cardiovascular disease — this includes heart attack and stroke — compared with people who do not have HIV. Increased chronic inflammation related to HIV may be contributing to the increased risk of heart disease.
Study Approach
In people without HIV, statin medications reduce cholesterol and prevent heart disease. In smaller studies among people with HIV, statins have also been shown to decrease inflammation; we need to confirm these findings among people living with HIV.
Participants in REPRIEVE will be randomized to receive pitavastatin or a placebo pill. Pitavastatin is a statin that is approved by the US based Federal Drug Authority (FDA) and approved for use as an investigational drug in Canada. Based on current information, pitavastatin is considered safe for use with all prescribed antiretroviral therapy regimens.
More information: www.reprievetrial.org
Eligibility Requirements
Required
- Living with HIV between the ages of 40 and 75
- On antiretroviral therapy (ART) for at least 6 months prior to study entry
- No history of cardiovascular disease (including heart attack or stroke)
- Not be currently using a statin drug
- Low to moderate risk for developing heart disease
- Not pregnant or planning on becoming pregnant
Not Allowed
- High risk of developing cardiovascular disease (ASCVD risk score >10% on ACC/AHA risk estimator)*
- Active major cancer within 3 years
- Cirrhosis
- Current use of immunosuppressants or other medications that could interact with pitavastatin
- Pregnancy or breastfeeding
Additional Information
If you would like more information on this clinical study, please refer to a participating site.
Principal Investigators
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Participating Sites
McMaster University Medical Centre, Special Immunology Services
Hamilton, ON
Dr. Marek Smieja
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Toronto General Hospital, Infectious Disease Division
Toronto, ON
Dr. Sharon Walmsley
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