HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

This study is looking at heart transplants for people living with HIV who also have advanced heart failure. It aims to see if receiving a heart from an HIV-positive deceased donor is as safe and effective as receiving one from an HIV-negative deceased donor. The study will compare the health outcomes of HIV-positive recipients, including how long they live and how well their new heart works, up to 4 years after the transplant. You may be able to join if you have advanced heart failure and HIV, and meet the standard requirements for a heart transplant at the local center. The study is currently unclear on its recruitment status and plans to enroll about 50 participants.

Study design: This is an interventional study, meaning participants will receive a specific treatment (an HIV-positive heart transplant). It is a single-center trial and plans to enroll 50 participants.
What's involved: You will undergo a standard evaluation for transplant eligibility. If you qualify, you will be informed about the study and asked to provide consent in a private setting.
Compensation: Not stated in the trial record.
Follow-up: The study will track your health and the function of your new heart for up to 4 years after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

Recruiting

NAAges 18+InterventionalTreatment

University of Texas Southwestern Medical Center

~50 participants

Updated 2026-01-21 on ClinicalTrials.gov

What's tested:HIV-positive heart transplant

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Time to a composite event of all-cause-mortality, graft failure, graft function

Measured over 4 years post-transplant

Conditions

HIV Infection

Advanced End Stage Heart Failure

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Ricardo La Hoz, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Ricardo La Hoz, M.D.

[email protected]

214/648-2163

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant meets the standard criteria for heart transplant at the local center.

Participant is able to understand and provide informed consent.

Participant meets with an independent advocate per the HOPE Act Safeguards and Research Criteria.

Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).\*

Participant is ≥ 18 years old.

Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.\*

CD4+ (cluster of differentiation 4+) T-cell count: ≥ 200/μL within 16 weeks of transplant.\*

HIV-1 RNA is below 50 copies RNA/mL.\*/\*\* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. \*\*Organ recipients who are unable to tolerate ART due to organ failure or recently started Antiretroviral Therapy (ART) may have detectable viral load and still be eligible if a safe and effective antiretroviral regimen to be used by the recipient after transplantation is described.

Participant is willing to comply with all medications related to their transplant and HIV management.

For participants with a history of aspergillus colonization or disease, no evidence of active disease.

The participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.

Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until after study completion.

Participant is not suffering from significant wasting (e.g. body mass index \< 21) thought to be related to HIV disease.

Exclusion

Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.\*

Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)

Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

What this trial measures

Time to a composite event of all-cause-mortality, graft failure, graft function4 years post-transplant
Time to event outcome measured as the time from randomization to the occurrence of the first event.

Trialytics