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

NCT03408106 | Completed DMC

• 1 other identifier: IRB00138153
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Adverse events

  incidence of adverse events related to nephrectomy

  at 1 year

Secondary Outcomes (4)

• chronic kidney disease

  through to study completion, up to 4 years

• hypertension

  through to study completion, up to 4 years

• change in antiretroviral therapy

  through to study completion, up to 4 years

• HIV virologic control

  through to study completion, up to 4 years

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV+ patients 21 years of age or older

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 23, 2018
• Study Start: August 1, 2017
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (2)