HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

NCT06659952 | Recruiting DMC

• 1 other identifier: STU-2024-0777
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective single-center interventional trial to compare the outcomes of HIV-positive heart transplant recipients by the HIV status of the donor; HIV-positive vs. HIV-negative and learn whether heart organ transplantation from HIV+ deceased donors is as safe and effective in HIV+ recipients as transplants from HIV- deceased donors. Patient will undergo standard evaluation for eligibility of transplantation by the primary heart transplant team. If patient meets eligibility criteria, they will be informed about the study and consent will be obtained. Informed consent will be obtained in a private clinic or inpatient hospital room in a confidential setting. HIV-positive or HIV-negative offers will be made by Organ Procurement and Transplantation Network (OPTN) (serving as a means of "natural randomization" and this information will also be collected, along with the information regarding any information for primary offer declines from the patients as well as other clinical indications to decline an organ offer. As a result of this, there will be two main groups in the study participants that will undergo analysis:

1. 1.patients/recipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+/R+ group)
2. 2.patients/recipients that are HIV+ who receive an organ from an HIV negative donor (HIV D-/R+ group)

Conditions

HIV Infection; Advanced End Stage Heart Failure

Keywords

HIV positive donor; HIV positive recipient; Heart transplant

Outcome Measures

Primary Outcomes (1)

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

  Time to event outcome measured as the time from randomization to the occurrence of the first event.

  4 years post-transplant

Secondary Outcomes (5)

• Number of participants who survived

  4 years post-transplant

• Incidence of Graft survival

  4 years post-transplant

• Number of Participants With One or More Serious Adverse Experience (SAE)

  4 years post-transplant

• Number of participants with graft rejection

  4 years post-transplant

• Incidence of graft function

  4 years post-transplant

Study Arms (2)

HIV D+/R+ Arm

EXPERIMENTAL

If HIV+ donor heart is available prior to HIV-negative donor heart, HIV-positive participant who agreed to receive HIV+ donor heart as part of this study receives the organ (heart) from an HIV- positive donor.

Other: HIV-positive heart transplant

HIV D-/R+ Arm (Control Arm)

NO INTERVENTION

If HIV- donor heart is available first, the HIV-positive participant receives the organ (heart) from an HIV- negative donor as part of standard organ waitlist/ clinical care.

Interventions

HIV-positive heart transplant OTHER

Receipt of heart from HIV-positive deceased donor only as part of this study

HIV D+/R+ Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• Individuals who meet any of these criteria are not eligible for enrollment as study participants:
• Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.\*

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ricardo La Hoz, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo La Hoz, M.D.

CONTACT

214/648-2163; Ricardo.LaHoz@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: "Natural randomization" will take place as OPTN organ offers become available and will be assigned to either arm based on whether the subject accepts/ declines the HIV+ donor heart.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2034
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)