1/2 reprieve extension for trial completion

Active Cooperative Agreement Awarded Last action

Award ID
UG3HL164285
Recipient
Awarding agency
Obligated
$44,501,147

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date 87% complete
Originally
Place of performance
Boston, MA 02114, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Abstract globally, cardiovascular disease (CVD) burden is increasing and a major cause of mortality among people with HIV (PWH). However, data are not yet available from large trials on an effective primary CVD prevention strategy for PWH. The ongoing reprieve trial will address this critical knowledge GAP, hypothesizing that statin therapy, with pleiotropic effects on LDL, immune activation and inflammatory pathways, will modify traditional and nontraditional risks and prevent major adverse cardiovascular events (mace) in PWH. Reprieve is well-positioned to provide high quality, clinically actionable and generalizable information to shift the current paradigm of HIV care, in alignment with the goals of nhlbi and OAR to reduce CVD and improve the overall health of PWH. Reprieve has met major challenges, anticipated for a large trial. 7,770 participants (31% female, 43% black, 25% latino) were enrolled from over 100 sites in 12 countries, a diverse, generalizable population. Retention is high, >90%. Endpoint (mace) are accumulating steadily despite a low median ascvd risk score of 4.5%, consistent with the hypothesis that nontraditional risks contribute to CVD in HIV. The mechanistic substudy has met its goal, enrolling over 800 participants for serial coronary CT angiography (CTA) and immune function. Preliminary baseline data from the substudy support our hypothesis, linking plaque to CVD risk but also independently to IL-6 and LP-PLA2, key indices of immune function and arterial inflammation that are being targeted in reprieve. Moreover, reprieve is being leveraged to assess statin effects on covid severity, and long-term effects in PWH, critical unanswered questions for the field. Reprieve has executed well over 6 years and is fundamentally strong. However, with a long duration of recruitment and protocol revisions to identify the optimal at-risk group given new guidelines, median duration of follow up is still short at 3.5 years. Reprieve needs additional time, projected at 2 years, plus a close out year, to collect necessary mace to ensure adequate power, analyze, and disseminate this data. The pressing need for data from a large global primary prevention trial has only grown since reprieve was initiated. Completion of the trial will protect the value of the initial NIH investment and honor the commitment to our participants and scientific community to meet the aims of the trial. This application for the clinical coordinating center (CCC) of the reprieve extension for trial completion focuses on the clinical rationale and coordination of the trial. The data coordinating center (DCC) application focuses on data management, including the coronary CTA data of the mechanistic substudy, and the statistical rationale for the trial design.

Transactions

Action Obligated Date
Amendment $0
Amendment $2,903,944
Amendment $2,903,944
Amendment $3,359,144
Amendment -$3,359,144
Amendment -$3,359,144
Amendment $3,359,144
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Amendment $4,747,407
Amendment $4,747,407
Amendment $4,747,407
Amendment $4,747,407
Amendment $6,567,877
Amendment $6,567,877
Original award $6,567,877
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Subawards

Subrecipient Amount Awarded
President And Fellows Of Harvard College CBAR will provide statistical leadership for the REPRIEVE trial, including all matters related to the study design and protocol development. CBAR… $290,466
Dlh, LLC STATEMENT OF WORK - DLH REPRIEVE (A5332) Supplement DLH, LLC supports clinical trials and functions as the Network Coordinating Center (NCC) for the ACTG. DLH… $36,742
University Of California, San Diego The Clinical Research Lab at the University of California San Diego will extract DNA from REPRIEVE specimens and send the appropriate amount of DNA to… $134,228
University Of Maryland, Baltimore The Clinical Core Research Lab at the University of Maryland Baltimore will perform a biomarker sub study using previously collected serum or plasma blood… $754,474
The Ohio State University Dr. Carlos Malvestutto, MD, has expertise in cardiovascular disease and HIV and was responsible for the clinical supervision and oversight of REPRIEVE,… $43,849
University Of California, LOS Angeles DLH NCC staff will provide support for the Randomized Trial To Prevent Vascular Events In HIV (REPRIEVE) study at the direction of the ACTG Network Leadership… $102,009
Rutgers The State University Of New Jersey For the proposed project, Dr. Burdo will continue to oversee biomarker testing on samples from the REPRIEVE trial relevant to our proposed study. Dr. Burdo will… $132,502
Inova Health Care Services Inova Biocore Research Laboratory will perform a biomarker sub study using previously collected serum or plasma blood samples collected at baseline and one-year… $2,183,317
Duke University Pamela Douglas, MD, served as a co-PI on the CCC with Dr. Grinspoon during the active phase of the trial and remains in this role during the REPRIEVE… $280,821
Cincinnati Univ Of Carl Fichtenbaum, MD, Professor of Medicine, served as Vice Chair of the REPRIEVE protocol working with the Co-PIs and chaired the Site Selection Performance… $58,780
President And Fellows Of Harvard College CBAR will provide statistical leadership for the REPRIEVE trial, including all matters related to the study design and protocol development. CBAR… $429,414
Inova Health Care Services Inova Biocore Research Laboratory will perform a biomarker sub study using previously collected serum or plasma blood samples collected at baseline and one-year… $1,433,444
Duke University Pamela Douglas, MD, will continue to be a co-PI on the CCC with Dr. Grinspoon. She will continue to work together with Dr. Grinspoon to supervise all aspects of… $195,490
University Of California, LOS Angeles DLH NCC staff will provide support for the Randomized Trial To Prevent Vascular Events In HIV (REPRIEVE) study at the direction of the ACTG Network Leadership… $107,875
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Quick answers

Who received award UG3HL164285?

UG3HL164285 was awarded to The General Hospital Corporation by National Heart Lung and Blood Institute (National Institutes of Health) on May 1, 2023.

How much is award UG3HL164285 worth?

$44,501,147 has been obligated on UG3HL164285.

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