Heart transplants from HIV-positive donors for HIV-positive recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial aims to evaluate the safety and effectiveness of heart transplants in HIV-positive recipients using organs from both HIV-positive and HIV-negative donors. Participants will undergo standard evaluations for transplant eligibility and will be informed about the study before providing consent. The study will compare clinical outcomes and potential complications between the two donor types, contributing to the understanding of organ transplantation in HIV-positive patients. The research is motivated by the need to expand the donor pool for this population, particularly in the context of heart transplants.

Why it matters

Who can join: the full rules

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.

* 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).\*
* Participant is ≥ 18 years old.
* Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.\*
* CD4+ (cluster of differentiation 4+) T-cell count: ≥ 200/μL within 16 weeks of transplant.\*
* HIV-1 RNA is below 50 copies RNA/mL.\*/\*\* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. \*\*Organ recipients who are unable to tolerate ART due to organ failure or recently started Antiretroviral Therapy (ART) may have detectable viral load and still be eligible if a safe and effective antiretroviral regimen to be used by the recipient after transplantation is described.
* Participant is willing to comply with all medications related to their transplant and HIV management.
* For participants with a history of aspergillus colonization or disease, no evidence of active disease.
* The participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.
* Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until after study completion.
* Participant is not suffering from significant wasting (e.g. body mass index \< 21) thought to be related to HIV disease.

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants:

* Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.\*
* Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)
* 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.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Ricardo La Hoz, M.D. — University of Texas Southwestern Medical Center
• Study coordinator: Ricardo La Hoz, M.D.
• Email: Ricardo.LaHoz@UTSouthwestern.edu
• Phone: 214/648-2163

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.