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

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT03408106
• Lead Sponsor: Johns Hopkins University

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 of HIV + living donors - including adverse events related to nephrectomy, development of chronic kidney disease, hypertension, and HIV-related complications.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2027-08-01
• Study Completion: 2030-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	at 1 year	incidence of adverse events related to nephrectomy

Secondary Outcome Measures

Name	Time	Method
change in antiretroviral therapy	through to study completion, up to 4 years	proportion of participants requiring change in antiretroviral therapy
hypertension	through to study completion, up to 4 years	time to hypertension defined as systolic blood pressure \> 140 mm Hg confirmed
chronic kidney disease	through to study completion, up to 4 years	time to significant proteinuria or glomerular filtration rate below 60 ml/min
HIV virologic control	through to study completion, up to 4 years	proportion of participants with HIV virologic failure or breakthrough

Trial Locations

Locations (2)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States