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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:21 - Any
Updated:1/23/2019
Start Date:August 1, 2017
End Date:December 31, 2022
Contact:Christine Durand, MD
Email:cdurand2@jhmi.edu
Phone:410-955-5684

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

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.

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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-5684
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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mi
from
Baltimore, MD
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