50 Participants Needed

HIV-Positive Heart Transplant for Patients with HIV

RL
EW
Overseen ByEmily Wong
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Antiretroviral therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that HIV-positive patients who receive heart transplants have survival rates similar to those of non-infected patients, thanks to advancements in antiretroviral therapy. This suggests that heart transplants can be a viable option for HIV-positive individuals.12345

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

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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

I have advanced heart failure and HIV, and meet the study's requirements.
I am eligible for a heart transplant according to my local center's rules.
Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA)
See 10 more

Exclusion Criteria

Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
I am currently pregnant or breastfeeding.
I have had progressive multifocal leukoencephalopathy or brain lymphoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Transplantation

Participants receive a heart transplant from either an HIV+ or HIV- donor

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after transplantation

4 years
Routine visits at weeks 52, 104, and 152 post-transplant

Treatment Details

Interventions

  • HIV-positive heart transplant
Trial Overview The study aims to determine if receiving a heart transplant from an HIV-positive donor is as safe and effective for HIV-positive recipients as getting one from an HIV-negative donor. There are two groups: those with both donor and recipient being HIV-positive, and those with only the recipient being positive.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HIV D+/R+ ArmExperimental Treatment1 Intervention
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.
Group II: HIV D-/R+ Arm (Control Arm)Active Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Findings from Research

A study comparing 75 HIV-positive heart transplant recipients to 29,848 HIV-negative recipients found no significant difference in short-term (30-day) and moderate-term (1-year and 5-year) survival rates, indicating that HIV-positive patients can have similar outcomes after transplantation.
Despite a higher rate of acute rejection and treatment for rejection in HIV-positive recipients, their HIV status did not significantly affect survival, suggesting that HIV-positive individuals should not be automatically excluded from heart transplant candidacy.
Heart Transplantation Survival Outcomes of HIV Positive and Negative Recipients.Doberne, JW., Jawitz, OK., Raman, V., et al.[2023]
This case study presents a woman who became HIV positive one year after receiving a heart transplant, highlighting the need for more data on the outcomes of heart transplantation in HIV-positive patients.
The report suggests that HIV status may not need to be an absolute contraindication for heart transplantation, indicating potential for successful long-term outcomes in such recipients.
Long-term follow-up of a heart transplant recipient with documented seroconversion to HIV-positive status 1 year after transplant.Gupta, S., Markham, DW., Mammen, PP., et al.[2023]
In a study of 7 HIV-positive patients who underwent cardiac transplantation, all patients remained alive with no significant AIDS-related complications or infections during an average follow-up of nearly 5 years.
The results suggest that with effective anti-retroviral therapy and careful selection, HIV-positive individuals can have excellent outcomes after cardiac transplantation, even as high-risk candidates.
Heart transplantation in human immunodeficiency virus-positive patients.Uriel, N., Jorde, UP., Cotarlan, V., et al.[2019]

References

Heart Transplantation Survival Outcomes of HIV Positive and Negative Recipients. [2023]
Long-term follow-up of a heart transplant recipient with documented seroconversion to HIV-positive status 1 year after transplant. [2023]
Heart transplantation in human immunodeficiency virus-positive patients. [2019]
Complex drug interactions in an HIV-seropositive heart transplant recipient. [2021]
Acute heart transplantation from mechanical circulatory support in a human immunodeficiency virus-positive patient with fulminant myocarditis. [2021]
Outcomes of heart transplantation in patients with human immunodeficiency virus. [2023]
Heart or lung transplant outcomes in HIV-infected recipients. [2020]
Review of transplantation in HIV patients during the HAART era. [2021]
HIV-Positive-to-HIV-Positive Liver Transplantation. [2023]
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