Actively Recruiting
A Prospective Study of HIV+ Deceased Donor Heart Transplant for HIV+ Recipients
Led by University of Texas Southwestern Medical Center · Updated on 2026-01-21
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and outcomes of heart transplants in people living with HIV who receive hearts from either HIV-positive or HIV-negative deceased donors. This study aims to understand whether receiving a heart from an HIV-positive donor is as safe and effective as receiving one from an HIV-negative donor. The trial also explores long-term health effects and mortality in HIV-positive heart transplant recipients, expanding knowledge in thoracic organ transplantation under the HIV Organ Policy Equity Act (HOPE Act). Participants who meet transplant eligibility will be offered hearts from either HIV-positive or HIV-negative donors based on availability, creating two main study groups. Those who accept an HIV-positive donor heart form the HIV D+/R+ group, while those receiving HIV-negative donor hearts form the HIV D-/R+ group. The study intervention is the receipt of the heart transplant; no additional experimental treatments or blood samples will be collected beyond standard care. After transplantation, participants will be followed through regular clinical visits at 1, 2, and 3 years post-transplant, with data collected from medical records. Researchers will assess outcomes like survival, graft function, rejection episodes, and serious adverse events up to four years after transplant. Overall participation involves routine evaluations without extra procedures, focusing on chart reviews to monitor transplant success and participant health over time.
CONDITIONS
Brief Title
HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with advanced heart failure and HIV infection
- Meet standard heart transplant criteria at the local center
- Able to understand and provide informed consent
- Meet with an independent advocate as per HOPE Act Safeguards
- Documented HIV infection by licensed test or history
- No active opportunistic infections; if past infection, treated and resolved
- CD4+ T-cell count of at least 200/µL within 16 weeks of transplant
- HIV-1 RNA below 50 copies/mL or managed viral load with safe antiretroviral therapy
- Willing to comply with transplant and HIV medication regimens
- No active aspergillus disease if previously colonized
- Willing to see a primary care provider experienced in HIV management
- Agreement to use effective contraception if of child-bearing potential
- Not suffering from significant HIV-related wasting (BMI 21 or higher)
You will not qualify if you...
- History of progressive multifocal leukoencephalopathy (PML) or primary CNS lymphoma
- Currently pregnant or breastfeeding
- Any other medical problems judged by investigators to pose added risks or interfere with study participation or data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years post-transplant
Participants receive a heart transplant from either an HIV-positive or HIV-negative deceased donor as part of this study.
Regular visits for transplant care and monitoring as per clinical protocol
Duration - Up to 4 years post-transplant
Participants are monitored long-term for safety, graft function, survival, and potential complications following the transplant.
Periodic visits for up to 4 years after transplant
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
R
Ricardo La Hoz, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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