# 2/2 REPRIEVE Extension for Trial Completion

> **NIH NIH U24** · MASSACHUSETTS GENERAL HOSPITAL · 2024 · $1,195,255

## Abstract

Project Summary/Abstract
This proposal will support the Data Coordinating Center (DCC) for the Randomized Trial to Prevent Vascular
Events in HIV Trial (REPRIEVE) Extension for up to two additional years, with an additional year for study
close-out. This additional time is necessary to collect the major adverse cardiovascular events (MACE)
required to ensure adequate power to address the primary aim of REPRIEVE, to determine the efficacy of
statins as a primary cardiovascular prevention strategy in HIV. Completion of the trial will protect the value of
the initial NIH investment and leverage existing REPRIEVE infrastructure, with its data analytical and oversight
structures. This DCC proposal is a companion to the REPRIEVE Clinical Coordinating Center (CCC) proposal.
REPRIEVE is a multicenter, randomized, placebo controlled, pragmatic trial investigating the efficacy of statins
for primary prevention of cardiovascular disease (CVD) events (primary endpoint) in 7,770 persons with HIV
(PWH) without known CVD and with low to moderate CVD risk as per the 2013 ACC/AHA Pooled Cohort
Equations, (referred to as ASCVD risk). To understand the biology of statin effects, 805 participants were co-
enrolled in an embedded mechanistic substudy that will determine the effects of statins on non-calcified plaque
volume and high risk plaque morphology using coronary computed tomographic angiography (CTA), as well as
on blood biomarkers of vascular inflammation and immune activation after 4 months and two years. Further, in
response to the global SARS-CoV-2 pandemic, REPRIEVE will address critical knowledge gaps regarding the
epidemiology of SARS-CoV-2 infection and COVID-related CVD complications among PWH, and determine
the protective statin effects for COVID disease across the globe.
In the proposed extension, the REPRIEVE DCC will continue to provide methodological and logistical support
for the collection, quality control, and analysis of data including rigorous, timely, and independent adjudication
of potential MACE events. Furthermore, the DCC remains responsible for statistical design and analysis,
assistance in protocol development, data management, CTA data acquisition and interpretation, biospecimen
analysis, and electronic communications.

## Key facts

- **NIH application ID:** 10831378
- **Project number:** 5U24HL164284-02
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Michael Tse-Yin Lu
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,195,255
- **Award type:** 5
- **Project period:** 2023-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10831378

## Citation

> US National Institutes of Health, RePORTER application 10831378, 2/2 REPRIEVE Extension for Trial Completion (5U24HL164284-02). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10831378. Licensed CC0.

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