NCT06659952

HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

A Prospective Study of HIV+ Deceased Donor Heart Transplant for HIV+ Recipients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. patients/recipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+/R+ group) 2. patients/recipients that are HIV+ who receive an organ from an HIV negative donor (HIV D-/R+ group) Only study participants will be able to receive organ offers from both HIV-positive and HIV-negative organ donors whichever is available first regardless of HIV status. This is the only study intervention. Baseline visit parameters will be obtained during a routine heart transplant visit. There will be no additional procedures or blood collection after the baseline study visit. Study data will be collected from chart review of routine post-transplant follow-up visits at weeks 52 (1 year), 104 (2 years), and 152 (3 years) after the transplant.

Detailed description

The primary objective is to evaluate the safety of heart transplantation in HIV-positive recipients and to study any potential complications of solid organ transplantation in the recipient, as well as assess the long-term health and mortality. Secondary objectives are to compare other clinical outcomes between HIV+ transplant recipients of hearts from HIV+ and HIV- donors. HIV D+/R+ transplantation is still less common than HIV D-/R+ transplantation due to the overall availability of donor organs. Additionally, most of the HIV D+/R+ transplants have been done for kidney transplants. Overall, there is more data accruing regarding transplantation and HIV disease, but most of the procedures are done in the kidney and liver organ systems. Not only is it important to further expand the donor pool for patients with HIV and heart failure, further data is needed in thoracic organ transplantation and HIV-positive recipients. The HIV Organ Policy Equity Act (HOPE Act - enacted on November 21, 2013), made it possible for an HIV+ recipient to receive an HIV+ organ as a part of a research study. HIV+ Deceased Donor Criteria: 1. Donation after brain death or cardiac death. 2. HIV+ donors have confirmed or suspected HIV infection\* (by medical record history and/or a licensed HIV test.) If HIV infection is diagnosed during the donor evaluation process, a second confirmatory test will be required). 3. Donor has no active opportunistic infections, neoplasms, or severe acute retroviral syndrome; if previous history of an opportunistic infection, donor has received appropriate treatment. 4. Donors may have any HIV-1 RNA viral load provided a safe, tolerable and effective post-transplant antiretroviral regimen to be prescribed for the recipient is anticipated, described and justified. 5. Donors with active hepatitis C virus (HCV) infection (detectable HCV nucleic acid by licensed assay in a Clinical Laboratory Improvement Amendments (CLIA) certified lab are acceptable based on local site practice.

Conditions

• HIV Infection
• Advanced End Stage Heart Failure

Interventions

Type	Name	Description
OTHER	HIV-positive heart transplant	Receipt of heart from HIV-positive deceased donor only as part of this study

Timeline

• Start date: 2024-11-13
• Primary completion: 2034-10-01
• Completion: 2034-10-01
• First posted: 2024-10-26
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States