About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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).*
Trial design
Parallel
Treatments tested in this trial
HIV-positive heart transplant
Other interventionReceipt of heart from HIV-positive deceased donor only as part of this study
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Number of participants who survived
Count of participants who survived
Incidence of Graft survival
Graft survival: Survival without re-transplantation or death related to graft dysfunction
Number of Participants With One or More Serious Adverse Experience (SAE)
Count of Participants With One or More Serious Adverse Experience (SAE) post transplant is assessed
Number of participants with graft rejection
Count of participants with graft rejection will be reported. Rejections will be defined by pathologist and clinician.
Sponsors and contacts
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