Single-Center Pilot Study of Living Donor Kidney Transplant from HIV-positive Donor to HIV-positive Recipient

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Hiv
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    Living Donors:
    1. Participants are between 18 and 100 years of age
    2. HIV-specific factors for eligibility:
      • CD4+ T Cell count = 500/µL for 6 months prior to evaluation
      • HIV-1 RNA < 50 copies RNA/mL
      • No evidence of renal disease prior to evaluation
      • Cleared for donor evaluation by living donor intake team
    Recipients:
    1. Participant who are between 18 and 100 years of age
    2. Evaluated and cleaned by Transplant Infectious Disease
    3. Demonstrated adherence to a stable ART regimen for = 6 months
    4. Demonstrated compliance with medical care and dialysis (if applicable) for = 6 months
    5. CD4+ T-cell counts = 200 cells per cubic millimeter while on stable ART therapy for a minimum of 16 weeks.
    6. Undetectable HIV type 1 (HIV-1) RNA levels (by RT-PCR)
    7. Participants with opportunistic infections while on stable ART
    8. If HBV or HCV co-infected:
      • HBV:Absence of HBSAg and Hepatitis B viremia (by PCR)
      • HCV:SVR-24 (undetectable PCR for 24 weeks)
      • Liver biopsy or FibroScan demonstrating fibrosis stage 3 or less
      • Absence of significant portal hypertension
      • Evaluation and clearance by Transplant Hepatology
    9. A completed HIV Resistance DNA GenoSure Archive Assay

You may not be eligible for this study if the following are true:

  • Living Donors:
    1. Subjects with history of any of the following conditions:
      • Progressive Multifocal leukoencephalopathy (PML)
      • Cryptosporidiosis, chronic intestinal
      • Coccidiomycosis
      • Pulmonary aspergillosis
      • Lymphoma
      • Non-cutaneous Kaposi’s sarcoma
    2. Human papilloma virus (HPV) associated cervical or anal disease including CIN/AIN III and carcinoma in situ
    3. Non-adherence with ART in preceding 6 months
    4. Subjects with persistent viremia despite appropriate ART
    5. Subjects with CD4+ T-cell counts <500 cells per cubic millimeter while on stable ART for a minimum of 6 months prior to donation
    6. Subjects with influenza or RSV infection within preceding 30 days
    Recipients:
    1. Subjects with history of any of the following conditions:
      • Progressive Multifocal leukoencephalopathy (PML)
      • Cryptosporidiosis, chronic intestinal
      • Coccidiomycosis
      • Pulmonary aspergillosis
      • Lymphoma
      • Non-cutaneous Kaposi’s sarcoma
    2. Human papilloma virus (HPV) associated cervical or anal disease including CIN/AIN III and carcinoma in situ
    3. Non-adherence with ART in preceding 6 months
    4. Subjects with persistent viremia despite appropriate ART
    5. Subjects with CD4+ T-cell counts < 200 cells per cubic millimeter while on stable ART for a minimum of 16 weeks
    6. Subjects with influenza or RSV infection within preceding 30 days
    7. Subjects who have an incomplete HIV Resistance DNA GenoSure Archive result



If you are registered as a volunteer, please login to the dashboard to send referrals.

Contact the research team to learn more about this study.

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