HIV InfectionsNCT03408106
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
An observational study of HIV Infections, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV+ patients 21 years of age or older
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Northwestern University
Chicago, Illinois, 60611
About this study
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Read the 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
incidence of adverse events related to nephrectomy
Measured: at 1 year
Secondary outcomes (4)
chronic kidney disease
time to significant proteinuria or glomerular filtration rate below 60 ml/min
Measured: through to study completion, up to 4 years
hypertension
time to hypertension defined as systolic blood pressure > 140 mm Hg confirmed
Measured: through to study completion, up to 4 years
change in antiretroviral therapy
proportion of participants requiring change in antiretroviral therapy
Measured: through to study completion, up to 4 years
HIV virologic control
proportion of participants with HIV virologic failure or breakthrough
Measured: through to study completion, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Aug 2017
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Durand, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408106
- Sponsor's protocol ID
- IRB00138153
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2018
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
- ClinicalTrials.gov ID
- NCT03408106
- Acronym / sponsor ID
- IRB00138153
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV+ patients 21 years of age or older
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse events
Time frame: at 1 year
incidence of adverse events related to nephrectomy
4 secondary outcomes
chronic kidney disease
Time frame: through to study completion, up to 4 years
hypertension
Time frame: through to study completion, up to 4 years
change in antiretroviral therapy
Time frame: through to study completion, up to 4 years
HIV virologic control
Time frame: through to study completion, up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Durand, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.