HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06659952
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HIV-positive heart transplant — OTHER
    Receipt of heart from HIV-positive deceased donor only as part of this study

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Jan 2026
Primary completion
Oct 31, 2034
Completion
Oct 31, 2034

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HIV D+/R+ Arm
    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.
  • No Intervention: HIV D-/R+ Arm (Control Arm)
    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.

Primary Outcome Measure

Time to a composite event of all-cause-mortality, graft failure, graft function [ Time Frame: 4 years post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Ricardo La Hoz, M.D.
[email protected]
214/648-2163
Emily Wong
[email protected]
214/648-2287
Ricardo La Hoz, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
HIV
By specialty
Infectious disease
By research site
UT Southwestern Medical Center· Dallas, TX

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