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CTN 293: REPRIEVE trial

Randomized Trial to Prevent Vascular Events in HIV

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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 6,500 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 Condition

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.

Eligibility criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Participating sites

Dr. Julian Falutz
Montreal General Hospital, Division of Geriatrics, Montreal
Tel: 514-937-6011

Dr. Marek Smieja
McMaster University Medical Centre, Special Immunology Services, Hamilton
Tel: 905-521-2100

Dr. Sharon Walmsley
Toronto General Hospital, Infectious Disease Division, Toronto
Tel: 416-340-4800

Dr. Sylvie Trottier
Centre hospitalier de l’Université CHU de Quebéc, Quebéc
Tel: 418-525-4444

Dr. Brian Conway
Vancouver ID Research & Care Centre Society, Vancouver
Tel: 604-642-6429

Dr. Graham Smith
Maple Leaf Clinic, Toronto
Tel: 416-465-7936

Dr. Jason Szabo
Clinique Medicale du L’actuel, Montreal
Tel: 514-524-3250

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

 

Principal Investigator

Dr. Steven K. Grinspoon
Massachusetts General Hospital

More information:
www.reprievetrial.org

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