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Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients

Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients

Non Recruiting
21 years and older
All
Phase N/A

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Overview

Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients

Description

This is a prospective study to evaluate the safety of donor nephrectomy in HIV+ individuals who donate kidneys to HIV+ candidates in need of transplant . The study will assess potential complications of HIV + living donors - including adverse events related to nephrectomy, development of chronic kidney disease, hypertension, and HIV-related complications.

Eligibility

Inclusion Criteria:

  • Able to understand and provide consent
  • Age 21 years or older
  • Meets standard clinical criteria for living donation per Johns Hopkins University (JHU) Comprehensive Transplant Center Policy
  • Documented HIV infection (by any licensed Enzyme-linked Immunosorbent Assay (ELISA) and confirmation by Western Blot, positive HIV Ab Immunofluorescent Assay (IFA), or documented history of detectable HIV-1 RNA)
  • CD4+ T-cell count ≥ 500/µL for 6 months prior to donation
  • HIV-1 RNA 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)

Exclusion Criteria:

  • Two high risk alleles of APOL1 (G1 or G2 variants)
  • Hypertension
  • Diabetes
  • Chronic active hepatitis C (detectable HCV RNA in plasma)
  • Evidence of invasive opportunistic complications from HIV infection
  • Mentally incompetent and/or inability to provide informed consent
  • Other medical conditions, as determined by the provider, that would preclude donation

Study details
    HIV Infections

NCT03408106

Johns Hopkins University

21 October 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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