HIV-Positive Heart Transplant for Patients with HIV

Overseen By Emily Wong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Antiretroviral therapy

Disqualifiers: PML, CNS lymphoma, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 54

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether heart transplants from HIV-positive donors are as safe and effective for people living with HIV as those from HIV-negative donors. HIV-positive participants with advanced heart failure might be eligible. The study compares outcomes for recipients of hearts from either HIV-positive or HIV-negative donors. The trial aims to expand donor options and improve transplant success for HIV-positive patients. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance transplant options for HIV-positive individuals.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that heart transplants are generally safe for people with HIV. Studies indicate that 96% of HIV-positive patients who receive a heart transplant survive the first 30 days after surgery. After one year, 88.1% of these patients continue to do well. Although there is a slightly higher risk of initial rejection of the new heart, the long-term survival rates remain encouraging and similar to those of patients without HIV. This evidence suggests that the procedure is well-tolerated and can be a viable option for people living with HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HIV-positive heart transplant approach because it opens new doors for HIV-positive patients needing transplants. Unlike standard heart transplants where only HIV-negative donors are considered, this method allows the use of hearts from HIV-positive donors. This not only increases the available donor pool but also reduces wait times, potentially saving lives. By leveraging organs from HIV-positive donors, the treatment could significantly alleviate the organ shortage for patients living with HIV.

What evidence suggests that this trial's treatments could be effective for HIV-positive heart transplant recipients?

Research has shown that heart transplants in people with HIV have survival rates similar to those without HIV, although data remains limited. Studies have found that individuals with HIV might face a higher risk of early rejection of the new heart, but their overall outcomes are comparable to those without HIV. In one study, a person with HIV underwent a successful heart transplant and remained well for 24 months post-surgery. This trial will compare two approaches: one where HIV-positive participants receive a heart from an HIV-positive donor, and another where they receive a heart from an HIV-negative donor. These findings suggest that heart transplants from HIV-positive donors to HIV-positive recipients could be a safe and effective option. ^{1 2 6 7 8}

Who Is on the Research Team?

Ricardo La Hoz, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: HIV D+/R+ Arm Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Transplantation Survival Outcomes of HIV Positive and Negative Recipients. Doberne, JW., Jawitz, OK., Raman, V., et al.[2023]

A study of 29 HIV-infected patients who received heart or lung transplants showed that their survival rates at 1, 3, and 5 years were similar to those of HIV-uninfected transplant recipients, indicating that HIV-infected individuals can successfully undergo these procedures.

Despite high rejection rates (62%) in heart transplant recipients and significant pulmonary bacterial infections (86%) in lung transplant recipients, serious complications related to HIV, such as infections and malignancies, were rare, suggesting that with careful management, transplantation can be safe for HIV-infected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart or lung transplant outcomes in HIV-infected recipients. Koval, CE., Farr, M., Krisl, J., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart transplantation in human immunodeficiency virus-positive patients. Uriel, N., Jorde, UP., Cotarlan, V., et al.[2019]

The long-term follow-up of an HIV-positive patient who received a heart transplant in 2006 highlights the effectiveness of highly active antiretroviral therapy in improving life expectancy for HIV patients.

The case emphasizes the management challenges posed by complex drug interactions over an 11-year period, underscoring the need for careful monitoring and adjustment of medications in transplant recipients with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex drug interactions in an HIV-seropositive heart transplant recipient. Sénéchal, I., Châteauvert, N., Gervais, P., et al.[2021]

A successful liver transplantation was performed from an HIV-positive donor to an HIV-positive recipient, demonstrating that organ transplants can be safely conducted between individuals with HIV under proper medical management.

Both the donor and recipient had been on antiretroviral therapy for years and maintained undetectable HIV levels five months post-transplant, supporting the idea that HIV-positive donors can be considered for transplants to HIV-positive recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-Positive-to-HIV-Positive Liver Transplantation. Calmy, A., van Delden, C., Giostra, E., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A 40-year-old HIV-positive patient with severe heart failure due to acute myocarditis successfully underwent heart transplantation after receiving temporary mechanical support, demonstrating the feasibility of such interventions in HIV-positive individuals.

This case supports the notion that HIV-positive patients can achieve similar survival outcomes post-transplant as non-infected patients, highlighting advancements in treatment and care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute heart transplantation from mechanical circulatory support in a human immunodeficiency virus-positive patient with fulminant myocarditis. Szakal-Toth, Z., Szlavik, J., Soltesz, A., et al.[2021]

In a study of 41 HIV-positive heart transplant recipients, the 1-year and 5-year survival rates were 85.9% and 77.3%, respectively, showing that HIV-positive patients can have excellent post-transplant outcomes.

When matched with HIV-negative recipients, there was no significant difference in survival rates, and the rates of cardiac allograft vasculopathy and malignancy were comparable, suggesting that more transplant centers should consider offering heart transplants to suitable HIV-positive candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of heart transplantation in patients with human immunodeficiency virus. Madan, S., Patel, SR., Saeed, O., et al.[2023]

Recent studies indicate that HIV-positive patients receiving highly active antiretroviral therapy (HAART) can have transplantation outcomes comparable to those without HIV, challenging previous beliefs about the risks associated with transplantation in these patients.

Despite improved outcomes, there are ongoing concerns regarding ethical considerations, patient selection, and potential drug interactions between antiretroviral therapies and immunosuppressive medications in the post-operative management of HIV-positive transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of transplantation in HIV patients during the HAART era. Pelletier, SJ., Norman, SP., Christensen, LL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9874795/

Heart Transplantation Survival Outcomes of HIV Positive and ... Short- and moderate-term survival following heart transplantation is similar in HIV-positive and HIV-negative recipients, although data are very limited.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105324982502279X

Early Experience in Heart Transplantation Utilizing Donors ... We conducted a single center observational study to compare early outcomes after heart transplantation (HTx) in HIV-positive recipients using ...

3. jhltonline.org jhltonline.org/article/S1053-2498(25)02319-8/abstract

Potential Pool of Cardiothoracic Organs from Donors with HIV If HIV D+/R+ is more widely expanded to cardiothoracic transplantation, 41% of HOPE kidney and liver donors have potential to donate a heart and ...

4. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(20)31484-3/fulltext

Heart Transplantation Survival Outcomes of HIV Positive ... These results suggest that heart transplantation in HIV-positive recipients confers a higher rate of initial acute rejection, but the same ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa022935

Successful Cardiac Transplantation in an HIV-1–Infected ... We report the 24-month follow-up of a patient infected with HIV type 1 (HIV-1) who underwent cardiac transplantation when his serologic status was known.

6. jhltonline.org jhltonline.org/article/S1053-2498(25)02279-X/abstract

Early experience in heart transplantation utilizing donors ... We conducted a single center observational study to compare early outcomes after heart transplantation (HTx) in HIV-positive recipients using ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1600613525002345

Comparable short-term survival in dual organ heart ... The primary outcome was patient survival. During the study period, 175 patients with HIV were transplanted. Twenty-six (14.8%) underwent dual organ ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6452439/

Outcomes in Human Immunodeficiency Virus Infected ... No significant differences were found in patient survival (88% vs 77%; p=0.1493), overall graft survival (85% vs 76%; p=0.2758) and death-censored graft ...