HIV InfectionNCT06659952
HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients
A study testing HIV-positive heart transplant in people with HIV Infection and Advanced End Stage Heart Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Advanced End Stage Heart Failure
- What is being tested?
- HIV-positive heart transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Ricardo La Hoz, M.D., 214/648-2163, Ricardo.LaHoz@UTSouthwestern.edu
Emily Wong, 214/648-2287, Emily.Wong@UTSouthwestern.edu
About this study
Official title: A Prospective Study of HIV+ Deceased Donor Heart Transplant for HIV+ Recipients
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:
Read more
- patients/recipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+/R+ group)
- 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.
Read the detailed description
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:
- Donation after brain death or cardiac death.
- HIV+ donors have confirmed or suspected HIV infection* (by medical record history and/or a licensed HIV test.) If HIV infection is diagnosed during the donor evaluation process, a second confirmatory test will be required).
- Donor has no active opportunistic infections, neoplasms, or severe acute retroviral syndrome; if previous history of an opportunistic infection, donor has received appropriate treatment.
- Donors may have any HIV-1 RNA viral load provided a safe, tolerable and effective post-transplant antiretroviral regimen to be prescribed for the recipient is anticipated, described and justified.
- Donors with active hepatitis C virus (HCV) infection (detectable HCV nucleic acid by licensed assay in a Clinical Laboratory Improvement Amendments (CLIA) certified lab are acceptable based on local site practice.
- Conditions
- HIV Infection, Advanced End Stage Heart Failure
- Being tested
- HIV-positive heart transplant
- Keywords
- HIV positive donor, HIV positive recipient, Heart transplant
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-positive heart transplantOther
Receipt of heart from HIV-positive deceased donor only as part of this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HIV-positive heart transplant |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years post-transplant
Secondary outcomes (5)
Number of participants who survived
Count of participants who survived
Measured: 4 years post-transplant
Incidence of Graft survival
Graft survival: Survival without re-transplantation or death related to graft dysfunction
Measured: 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
Measured: 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.
Measured: 4 years post-transplant
Incidence of graft function
Graft function will be assessed by echocardiography - Left Ventricular ejection function
Measured: 4 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start13 Nov 2024
- Primary completionOct 2034 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo La Hoz, University of Texas Southwestern Medical Center
- Investigators
- Ricardo La Hoz, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659952
- Sponsor's protocol ID
- STU-2024-0777
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of HIV+ Deceased Donor Heart Transplant for HIV+ Recipients
- ClinicalTrials.gov ID
- NCT06659952
- Acronym / sponsor ID
- STU-2024-0777
- Conditions
- HIV Infection, Advanced End Stage Heart Failure
- Keywords
- HIV positive donor, HIV positive recipient, Heart transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Oct 2034 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- patients/recipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+/R+ group)
- 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.
Detailed description
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:
- Donation after brain death or cardiac death.
- HIV+ donors have confirmed or suspected HIV infection* (by medical record history and/or a licensed HIV test.) If HIV infection is diagnosed during the donor evaluation process, a second confirmatory test will be required).
- Donor has no active opportunistic infections, neoplasms, or severe acute retroviral syndrome; if previous history of an opportunistic infection, donor has received appropriate treatment.
- Donors may have any HIV-1 RNA viral load provided a safe, tolerable and effective post-transplant antiretroviral regimen to be prescribed for the recipient is anticipated, described and justified.
- Donors with active hepatitis C virus (HCV) infection (detectable HCV nucleic acid by licensed assay in a Clinical Laboratory Improvement Amendments (CLIA) certified lab are acceptable based on local site practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "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.
| Arm | Type | Receives |
|---|---|---|
| HIV D+/R+ Arm | Experimental | Other: HIV-positive heart transplantIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).*
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV-positive heart transplantReceipt of heart from HIV-positive deceased donor only as part of this study | Other | HIV D+/R+ Arm |
Primary outcome
Time to a composite event of all-cause-mortality, graft failure, graft function
Time frame: 4 years post-transplant
Time to event outcome measured as the time from randomization to the occurrence of the first event.
5 secondary outcomes
Number of participants who survived
Time frame: 4 years post-transplant
Incidence of Graft survival
Time frame: 4 years post-transplant
Number of Participants With One or More Serious Adverse Experience (SAE)
Time frame: 4 years post-transplant
Number of participants with graft rejection
Time frame: 4 years post-transplant
Incidence of graft function
Time frame: 4 years post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for HIV Infection
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo La Hoz, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV-positive heart transplant in people with HIV Infection and Advanced End Stage Heart Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo La Hoz, M.D. (214/648-2163, Ricardo.LaHoz@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to a composite event of all-cause-mortality, graft failure, graft function (time frame: 4 years post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.