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Procedure

HIV-Positive Heart Transplant for Patients with HIV

N/A

Waitlist Available

Led By Ricardo La Hoz, M.D.

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is able to understand and provide informed consent

Participant meets the standard criteria for heart transplant at the local center

Must not have

Participant is pregnant or breastfeeding. 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

Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the outcomes of heart transplant recipients who are HIV-positive based on whether they receive a heart from an HIV-positive or HIV-negative donor. The study will evaluate if heart transplants from

Who is the study for?

This trial is for HIV-positive individuals who are candidates for a heart transplant. They will be compared based on whether they receive a heart from an HIV-positive or HIV-negative donor. Participants must meet the standard criteria for heart transplantation and consent to join the study.

What is being tested?

The study aims to determine if receiving a heart transplant from an HIV-positive donor is as safe and effective for HIV-positive recipients as getting one from an HIV-negative donor. There are two groups: those with both donor and recipient being HIV-positive, and those with only the recipient being positive.

What are the potential side effects?

Since this trial involves standard post-heart transplant care without additional procedures, side effects would typically include risks associated with any heart transplant such as organ rejection, infection, medication side effects, or complications related to underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study details and can give my consent.

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I am eligible for a heart transplant according to my local center's rules.

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I am 18 years old or older.

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I am willing to follow all medication guidelines for my transplant and HIV treatment.

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My BMI is 21 or above and I do not have significant weight loss due to HIV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I have had progressive multifocal leukoencephalopathy or brain lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to a composite event of all-cause-mortality, graft failure, graft function

Secondary study objectives

Incidence of Graft survival

Incidence of graft function

Number of Participants With One or More Serious Adverse Experience (SAE)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HIV D+/R+ ArmExperimental Treatment1 Intervention

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.

Group II: HIV D-/R+ Arm (Control Arm)Active Control1 Intervention

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.

0 / 7Eligibility criteria met