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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

NCT03734393

Hiv

ACTIVE_NOT_RECRUITING NA

Kidney Transplant for HIV-Infected Patients in Renal Failure

NCT00009009

Chronic Kidney Failure HIV Infection

COMPLETED PHASE2

Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals

NCT01836068

HIV

COMPLETED EARLY_PHASE1

Renal Transplantation and Raltegravir in HIV-Infected Patients

NCT01453192

HIV-1 Infection Chronic Renal Insufficiency

COMPLETED PHASE3

Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

NCT01968551

HIV-1 HIV Infections Acquired Immunodeficiency Syndrome

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No