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NCT03408106 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03408106
Other study ID # IRB00138153
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date August 1, 2030

Study information
Verified date September 2023
Source Johns Hopkins University
Contact Christine Durand, MD
Phone 410-955-5684
Email cdurand2@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date August 1, 2030
Est. primary completion date August 1, 2027
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events incidence of adverse events related to nephrectomy at 1 year
Secondary chronic kidney disease time to significant proteinuria or glomerular filtration rate below 60 ml/min through to study completion, up to 4 years
Secondary hypertension time to hypertension defined as systolic blood pressure > 140 mm Hg confirmed through to study completion, up to 4 years
Secondary change in antiretroviral therapy proportion of participants requiring change in antiretroviral therapy through to study completion, up to 4 years
Secondary HIV virologic control proportion of participants with HIV virologic failure or breakthrough through to study completion, up to 4 years
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