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

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ClinicalTrials.gov Identifier: NCT03408106
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease
HIV Infections

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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Adverse events [ Time Frame: at 1 year ]
    incidence of adverse events related to nephrectomy


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood, tissue


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV+ patients 21 years of age or older
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408106


Contacts
Contact: Christine Durand, MD 410-955-5684 cdurand2@jhmi.edu
Contact: Dorry Segev, MD, PhD 401-502-6115 dorry@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Christine Durand, MD    410-955-5684    cdurand2@jhmi.edu   
Contact: Dorry Segev, MD, PhD    410-502-6115    dorry@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03408106     History of Changes
Other Study ID Numbers: IRB00138153
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases