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 Year(s) - 100 Year(s)
  • 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



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