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

Johns Hopkins University

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT03408106

IRB00138153

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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