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NCT06659952 · ClinicalTrials.gov registry record · NA
HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients
A NA study of HIV Infection and Advanced End Stage Heart Failure, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06659952 is a NA study of HIV Infection and Advanced End Stage Heart Failure that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06659952, a NA study of HIV Infection and Advanced End Stage Heart Failure, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- OTHER HIV-positive heart transplant
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2034-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06659952
The ClinicalTrials.gov registry entry for NCT06659952 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (79% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which HIV-positive heart transplant is the first listed.
NCT06659952 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06659952 about?
NCT06659952 is a clinical study titled "HIV+ Deceased Donor Heart Transplant Study 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+ rec...
What is the current status of trial NCT06659952?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-11-13. Estimated completion is 2034-10.
What conditions does trial NCT06659952 study?
This clinical trial studies the following conditions: HIV Infection, Advanced End Stage Heart Failure.
What interventions are being tested in trial NCT06659952?
The interventions under investigation include: HIV-positive heart transplant (OTHER).
Who is sponsoring clinical trial NCT06659952?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06659952 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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