HIV-Positive Heart Transplant for Patients with HIV
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to comply with all medications related to your transplant and HIV management.
What data supports the effectiveness of the HIV-positive heart transplant treatment?
Is heart transplantation safe for HIV-positive patients?
Research shows that heart transplants in HIV-positive patients have good survival rates, similar to those without HIV. At 5 years post-transplant, survival is about 77.3%, and the rates of complications like heart vessel disease and cancer are comparable to the general heart transplant population.12367
How is the HIV-positive heart transplant treatment different from other treatments for HIV-positive patients?
The HIV-positive heart transplant is unique because it involves transplanting a heart from an HIV-positive donor to an HIV-positive recipient, which was previously considered a contraindication. This approach is made possible by advancements in antiretroviral therapy, allowing HIV-positive patients to have similar transplant outcomes to those without HIV.12389
What is the purpose of this trial?
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.
Research Team
Ricardo La Hoz, MD
Principal Investigator
UT Southwestern Medical Center
Eligibility Criteria
This trial is for HIV-positive individuals who are candidates for a heart transplant. They will be compared based on whether they receive a heart from an HIV-positive or HIV-negative donor. Participants must meet the standard criteria for heart transplantation and consent to join the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Transplantation
Participants receive a heart transplant from either an HIV+ or HIV- donor
Follow-up
Participants are monitored for safety and effectiveness after transplantation
Treatment Details
Interventions
- HIV-positive heart transplant
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor