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New treatment option for HIV Infection
Official title HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients
ClinicalTrials.gov ID: NCT06659952
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All individuals with advanced heart failure and HIV infection who meet the study inclusion and
You likely can't join if
- 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.
See the full eligibility criteria
- All individuals with advanced heart failure and HIV infection who meet the study inclusion and
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.