Status:
ACTIVE_NOT_RECRUITING
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Lead Sponsor:
Johns Hopkins University
Conditions:
HIV Infections
Eligibility:
All Genders
21+ years
Brief Summary
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03408106
Start Date
August 1 2017
End Date
August 1 2030
Last Update
September 4 2025
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Johns Hopkins University
Baltimore, Maryland, United States, 21205