HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients
A Prospective Study of HIV+ Deceased Donor Heart Transplant for HIV+ Recipients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults with HIV and advanced heart failure who qualify for a heart transplant. It compares hearts from deceased donors with and without HIV to learn whether both are as safe and work as well for people with HIV.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, have confirmed HIV, and meet the center’s usual rules for a heart transplant.
- Be able to understand and agree to join the study, and meet with an independent person who protects your interests.
- Have a CD4 count (a measure of immune cells) of at least 200 cells/μL within 16 weeks before the transplant.
- Have an HIV level below 50 copies/mL. Some brief rises are allowed. Exceptions may apply if you recently started HIV drugs or cannot take them because of organ failure, with a safe, effective plan for HIV drugs after transplant.
- Have no active infection from a past illness linked to a weak immune system, and have received proper treatment. If you have had Aspergillus, a type of fungus, it must not be causing active disease.
- Be willing to take all transplant and HIV medicines, and have or agree to see a primary care provider skilled in HIV care.
- Agree to use birth control. Women who can become pregnant must choose a suitable method with their doctor and use it from the start of study treatment until after the study ends.
- Have no major weight or muscle loss thought to be caused by HIV, such as a body mass index (BMI) below 21.
Who can't join
- Have ever had PML, a serious brain infection, or primary CNS lymphoma, a cancer in the brain or spinal cord.
- Be pregnant or breastfeeding when joining the study.
- Have other health problems or test results that the study doctor thinks could make joining unsafe, prevent you from following study rules, or affect the study results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
TX
- UT Southwestern Medical Center · Dallas, TX 75390Ricardo La Hoz, M.D. · Study contact · 214/648-2163 · Ricardo.LaHoz@UTSouthwestern.eduEmily Wong · Study contact · 214/648-2287 · Emily.Wong@UTSouthwestern.eduRicardo La Hoz, M.D. · Principal investigatorMore trials in Dallas