Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected A… (NCT02344290) | Clinical Trial Compass
CompletedPhase 3
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
United States, Botswana, Brazil7,769 participantsStarted 2015-03-26
Plain-language summary
People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).
The REPRIEVE trial consisted of two parallel identical protocols:
* REPRIEVE (A5332) was funded by the NHLBI, with additional infrastructure support provided by the NIAID, and was conducted in U.S and select international sites (approximately 120 sites in 11 countries).
* REPRIEVE (EU5332) was co-sponsored by NEAT ID and MGH, and was conducted at 13 sites in Spain.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individual with HIV-1
* Combination antiretroviral therapy (ART) for at least 180 days prior to study entry
* CD4+ cell count greater than 100 cells/mm\^3
* Acceptable screening laboratories including:
* Fasting low-density lipoprotein (LDL) cholesterol as follows:
* If ASCVD risk score was less than 7.5%, LDL cholesterol must have been less than 190 mg/dL.
* If ASCVD risk score was greater than or equal to 7.5% and less than or equal to 10%, LDL must have been less than 160 mg/dL.
* If ASCVD risk score was greater than 10% and less than or equal to 15%, LDL must have been less than 130 mg/dL.
* Participants with LDL less than 70 mg/dL were eligible regardless of the 10-year ASCVD risk score, in line with the ACC/AHA 2013 Prevention Guidelines.
* Fasting triglycerides less than 500 mg/dL
* Hemoglobin greater than or equal to 8 g/dL for female participants and greater than or equal to 9 g/dL for male participants
* Glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m\^2 or creatinine clearance (CrCl) greater than or equal to 60 mL/min
* Alanine aminotransferase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN)
* For persons with known chronic active hepatitis B or C, calculated fibrosis 4 score (FIB-4) must have been less than or equal to 3.25
* Ability and willingness of participant or legal representative to provide written informed consent
Exclusion Criteria:
* Clinical ASCVD, as defin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rate of Major Adverse Cardiovascular Event (MACE)
Timeframe: From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
Trial details
NCT IDNCT02344290
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)