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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:
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV-positive heart transplant | Other | Receipt of heart from HIV-positive deceased donor only as part of this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who survived | Count of participants who survived | 4 years post-transplant |
| Incidence of Graft survival | Graft survival: Survival without re-transplantation or death related to graft dysfunction |
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Inclusion Criteria:
All individuals with advanced heart failure and HIV infection who meet the study inclusion and exclusion criteria will be eligible for participation in the study.
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo La Hoz, M.D. | Contact | 214/648-2163 | Ricardo.LaHoz@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo La Hoz, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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"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.
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| 4 years post-transplant |
| 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 | 4 years post-transplant |
| Number of participants with graft rejection | Count of participants with graft rejection will be reported. Rejections will be defined by pathologist and clinician. | 4 years post-transplant |
| Incidence of graft function | Graft function will be assessed by echocardiography - Left Ventricular ejection function | 4 years post-transplant |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |