Clinical trial 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
- The study compares outcomes of HIV‑positive heart transplant recipients who receive hearts from HIV‑positive donors versus those who receive hearts from HIV‑negative donors.
- Who it's for
- HIV‑positive adults with advanced end‑stage heart failure who are eligible for a heart transplant.
- What's involved
- Participants undergo the usual transplant evaluation, give consent, and receive a donor heart (either HIV‑positive or HIV‑negative). No extra tests or blood draws are added beyond routine care.
- Time commitment
- Participants are followed at routine clinic visits at 1, 2, and 3 years after transplant; no additional study visits are required.
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.
- 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.
- 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.
- 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.
- 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 is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.