Study Objectives

Primary Clinical Objective

  • To determine the effects of Pitavastatin as a primary prevention strategy for Major Adverse Cardiovascular Events (MACE) in HIV

Secondary Objectives

  • To evaluate the effects of pitavastatin on each of the components of the primary composite MACE endpoint and all-cause mortality.
  • To determine the effects of pitavastatin on LDL and non-HDL cholesterol in the HIV population and assess the relationship of changes in LDL and non-HDL to the incidence of MACE.
  • To evaluate whether baseline traditional risk factors (including smoking, hypertension, dyslipidemia, glucose) and time updated HIV-specific (immunological and virological) risk factors are predictive of MACE and pitavastatin effects on MACE in the HIV population.
  • To evaluate whether baseline and time updated inflammatory and immune activation biomarkers are predictive of MACE and pitavastatin effects on MACE in the HIV population.
  • To determine the effects of pitavastatin on the incidence of serious non-cardiovascular events and AIDS-defining events.
  • To determine the safety of pitavastatin in the HIV population, including the development of diabetes mellitus (DM), liver dysfunction, and myopathy.
  • To collect blood to enable the evaluation of the relationship of host genetics to study cardiovascular endpoints in subsequent ancillary studies. Genetic testing will be restricted to the study of genes thought to be associated with risk of cardiovascular disease

Study Design: REPRIEVE (A5332) is a prospective, double-blind, randomized, placebo-controlled, multicenter phase III efficacy study.

Study Population: The target sample size of REPRIEVE (A5332) is 6500 individuals internationally. Number of participants enrolled in Botswana is 281.

Study Duration: 6 years.

Study Results: not available.

Study Status: Enrollment complete. On long term follow-up

Sponsor

  • National Heart, Lung, and Blood Institute
  • National Institute of Allergy and Infectious Diseases.
  • National Institute of Diabetes and Digestive and Kidney Diseases