HIV-positive kidney donation from living donors to HIV-positive recipients
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
This study tests whether it's safe for HIV-positive people to donate kidneys to other HIV-positive patients who need a transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT03408106 on ClinicalTrials.gov |
What this trial studies
This prospective study evaluates the safety of kidney donation from HIV-positive individuals to HIV-positive recipients in need of a transplant. It focuses on assessing potential complications related to donor nephrectomy, including adverse events, chronic kidney disease, hypertension, and HIV-related complications. The study aims to provide insights into the viability and safety of living donor transplants within this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals aged 21 and older who meet specific clinical criteria for living donation.
Not a fit: Patients with significant comorbidities such as hypertension, diabetes, or chronic active hepatitis C may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance kidney transplant options for HIV-positive patients, improving their health outcomes.
How similar studies have performed: While this approach is relatively novel, there have been limited studies exploring similar living donor transplant scenarios for HIV-positive individuals.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Christine Durand, MD — Johns Hopkins University
- Study coordinator: Christine Durand, MD
- Email: cdurand2@jhmi.edu
- Phone: 410-955-5684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.