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NCT Number: NCT03408106

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adverse events

    Time frame: at 1 year

    incidence of adverse events related to nephrectomy

Secondary outcomes

  1. chronic kidney disease

    Time frame: through to study completion, up to 4 years

    time to significant proteinuria or glomerular filtration rate below 60 ml/min

  2. hypertension

    Time frame: through to study completion, up to 4 years

    time to hypertension defined as systolic blood pressure > 140 mm Hg confirmed

  3. change in antiretroviral therapy

    Time frame: through to study completion, up to 4 years

    proportion of participants requiring change in antiretroviral therapy

  4. HIV virologic control

    Time frame: through to study completion, up to 4 years

    proportion of participants with HIV virologic failure or breakthrough

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2018
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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