Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

HOPE Heart study: A Clinical Trial of HIV to HIV Transplantation

Award Number: U01AI198070
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/20/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2033

Group Awards By:

View Award Description

HOPE Heart study: A Clinical Trial of HIV to HIV Transplantation - PROJECT SUMMARY/ABSTRACT We led the landmark trials in kidney (U01AI134591; NEJM 2024) and liver (U01AI138897) to establish the safety and efficacy of HOPE transplants, resulting in the 2024 HHS decision to expand HIV D+/R+ kidney and liver transplantation beyond research protocols to clinical practice. Yet the HOPE Act promise of heart transplants remains unrealized. People with HIV have twice the risk of clinical heart failure as the general population (6.5% prevalence), and HIV-associated cardiomyopathy is a major long-term complication of HIV infection. Transplanting hearts from donors with HIV (HIV D+) could lead to substantial public health benefit by decreasing the organ shortage, wait times, and waitlist mortality for people with and without HIV on the heart waitlist. Heart transplantation from donors without HIV to recipients with HIV (HIV D-/R+) confers a substantial survival advantage (77% vs 33% at 5 years), with post-transplant survival comparable to recipients without HIV. We performed the world’s first HIV D+/R+ heart transplants, and our 6 recipients are alive with follow-up as long as 3 years. In the proposed multicenter trial, we will evaluate the safety and efficacy of HIV D+/R+ heart transplantation. Furthermore, we will conduct important mechanistic studies to characterize dysregulated adaptive immune responses common to HIV and transplantation, linking them with allograft inflammation/fibrosis and clinical endpoints in the trial. Participants with HIV will be offered HIV D+ and HIV D- (including false positive) hearts as they become available in a quasi-random process mimicking a randomized trial. We will compare outcomes in 40 HIV D+/R+ and 40 HIV D-/R+ heart transplant recipients, enrolled over 5 years at 25 transplant centers. We aim: (1) to compare heart transplant outcomes (rejection, graft failure, and mortality) between HIV D+/R+ and HIV D-/R+, (2) to investigate whether dysregulated adaptive immune responses are associated with increased progression of inflammation and rejection after transplantation, in HIV D+/R+ recipients versus HIV D-/R+ recipients, and (3) to investigate whether HIV D+/R+, versus HIV D-/R+ recipients, demonstrate more intragraft inflammation and fibrosis, particularly whether inflammation and subclinical fibrosis in HIV D+ donor hearts is associated with clinical endpoints of the trial, and whether rejection in HIV D+/R+ has a distinct phenotype from rejection in HIV D-/R+. The proposed trial will determine whether the use of hearts from HIV D+ donors is safe and effective. If HIV D+/R+ transplantation can be implemented, the additional donors will help save the lives of both patients with and without HIV. The mechanistic studies have been designed to complement clinical endpoints, ensuring the knowledge gained will be novel and informative regardless of outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,717,417 )
2026	2026	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	002	1	8/18/2026	NEW	$0
2026	2026	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	001	1	8/5/2026	NEW	$0
2026	2026	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	4/21/2026	NEW	$1,717,417
														Subtotal = $1,717,417

Grand Total All Awards = $1,717,417

Top

All Categories

About

Search

Reports

Data Submission

Award Information

HOPE Heart study: A Clinical Trial of HIV to HIV Transplantation

Award Number: U01AI198070

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/20/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2033

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer