Kidney Transplantation for HIV
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Pregnancy, Breastfeeding, PML, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to understand any specific requirements.
What data supports the effectiveness of the treatment Kidney Transplantation for HIV?
Research shows that kidney transplantation in HIV-infected individuals with end-stage kidney disease can improve survival compared to dialysis. However, these patients may face higher rates of acute rejection, which means the body might try to attack the new kidney.
12345Is kidney transplantation safe for HIV-positive patients?
Kidney transplantation is generally considered safe for HIV-positive patients, with studies showing similar patient and graft survival rates compared to HIV-negative recipients. However, there are higher rates of acute rejection and some metabolic complications, but HIV control remains stable in most cases.
26789How is kidney transplantation unique for treating end-stage renal disease in HIV-positive patients?
Kidney transplantation is unique for HIV-positive patients because it was once considered too risky due to concerns about HIV progression and drug interactions, but advances in antiretroviral therapy (ART) and immunosuppression have made it a viable option, offering similar outcomes to those without HIV.
1231011Eligibility Criteria
This trial is for adults over 18 with HIV who need a kidney transplant. They must have low levels of HIV in their blood, be generally healthy without significant weight loss from HIV, and meet local transplant criteria. People can't join if they're pregnant, breastfeeding, or have certain serious health issues like brain infections or lymphoma.Inclusion Criteria
Participant meets with an independent advocate
I understand the study and can give my consent.
Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA
+5 more
Exclusion Criteria
Participant is pregnant or breastfeeding
Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
I have had PML, long-term cryptosporidiosis, or brain lymphoma.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Transplantation
Participants receive kidney transplants from donors with or without HIV
Immediate
1 visit (in-person)
Follow-up
Participants are monitored for safety, effectiveness, and incidence of rejection, infections, and other complications
At least 1 year, up to 4 years
Regular visits (in-person and virtual)
Participant Groups
The study compares the outcomes of kidney transplants in people with HIV receiving kidneys from donors with and without HIV. It aims to understand how donor status affects organ rejection and long-term health after transplantation.
2Treatment groups
Experimental Treatment
Group I: HIV D-/R+Experimental Treatment1 Intervention
People living with HIV who receive kidneys from deceased donors without HIV
Group II: HIV D+/R+Experimental Treatment1 Intervention
People living with HIV who receive kidneys from deceased donors with HIV
Kidney Transplantation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Kidney Transplantation for:
- End-stage renal disease (ESRD) in HIV-positive patients
🇪🇺 Approved in European Union as Kidney Transplantation for:
- Chronic kidney disease in HIV-positive patients
- End-stage renal disease (ESRD) in HIV-positive patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
Massachusetts General HospitalBoston, MA
Yale School of MedicineNew Haven, CT
Icahn School of Medicine at Mt. SinaiNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
Effectiveness of kidney transplantation in HIV-infected recipients under combination antiretroviral therapy: a single-cohort experience (Brescia, Northern Italy). [2018]Kidney transplantation was recently introduced for the treatment of end stage renal disease (ESRD) in HIV-infected patients. We report the results of the first 28 procedures at our centre.
Immunosuppression regimen and the risk of acute rejection in HIV-infected kidney transplant recipients. [2022]Kidney transplantation (KT) is the treatment for end-stage renal disease in appropriate HIV-positive individuals. However, acute rejection (AR) rates are over twice those of HIV-negative recipients.
Kidney transplants in HIV-positive recipients under HAART. A comprehensive review and meta-analysis of 12 series. [2010]Kidney transplantation is being introduced gradually for the treatment of end-stage renal disease in patients who are human immunodeficiency virus (HIV) positive. Our aim was to review the outcomes of kidney transplantation in HIV-positive recipients who were being treated with highly active antiretroviral therapy (HAART).
Complications of rabbit anti-thymocyte globulin induction immunosuppression in HIV-infected kidney transplant recipients. [2023]Label="Background" NlmCategory="UNASSIGNED">Kidney transplantation in HIV-infected individuals with end-stage kidney disease is associated with improved survival compared to dialysis. Rabbit anti-thymocyte globulin (rATG) induction in HIV-infected kidney transplant recipients has been associated with a lower risk of acute rejection, but data on the rates of de novo malignancy and BK viremia in these patients is lacking.
Outcomes of kidney transplantation in HIV-infected recipients. [2022]The outcomes of kidney transplantation and immunosuppression in people infected with human immunodeficiency virus (HIV) are incompletely understood.
First Canadian Case Report of Kidney Transplantation From an HIV-Positive Donor to an HIV-Positive Recipient. [2022]Kidney transplantation has become standard of care for carefully selected patients living with human immunodeficiency virus (HIV) and end-stage renal disease (ESRD) in the highly active antiretroviral therapy (HAART) era. American and European prospective cohort studies have reported similar patient and graft survival compared with HIV-negative kidney transplant recipients. Despite an increased rate of acute rejection, partially due to drug interactions, HIV immunovirologic parameter generally remains under control during immunosuppression. A few cases of kidney transplantation between HIV-infected patients were done in South Africa and showed favorable results. No cases of kidney transplantation from an HIV-positive donor in Canada have previously been reported.
In sickness and in health: Living HIV positive kidney donation from a wife to her husband, with 7 years' post-transplant follow-up. [2020]Human immunodeficiency virus (HIV) infection was traditionally considered an absolute contraindication for kidney transplantation. After the introduction of ART, several studies have demonstrated comparable patient and graft outcomes between HIV-negative and HIV-positive kidney recipients. The US Congress passed the HIV Organ Policy Equity (HOPE) Act in 2013, which permits research in the area of HIV-positive to HIV-positive transplantation. HIV-infected living donation is also permitted under the HOPE Act. However, there is a concern regarding the safety of kidney donation in an HIV-infected person, given the risk of renal disease associated with HIV infection. We report here the case of successful kidney transplantation from HIV-positive living donor to HIV-positive recipient performed in our center on July 2012. To the best of our knowledge, this is the earliest case done in this medical context to be reported in the literature, therefore, potentially carrying several important messages to the transplantation community. In the present case, the living-donor kidney transplant was performed between a married couple infected with same strain of HIV-1, both on effective ART with efficiently suppressed viral replication and satisfactory pre-transplantation immune status.
Kidney transplantation for HIV-positive patients. [2018]HIV+ patients are at increased risk for end-stage renal disease, but HIV infection was once considered a contraindication to renal transplantation. However, contemporary studies from the United States and Europe have now demonstrated that renal transplantation is a safe and effective treatment for end-stage renal disease in HIV patients, with equivalent patient and allograft survival to those uninfected. Broader experience in transplantation in HIV+ patients has identified unique challenges including high rates of acute rejection, delayed graft function, and significant drug-drug interactions. Kidney transplantation in HIV-infected patients is an active area of clinical research and trials of HIV+ to HIV+ transplantation in the United States are underway.
Clinical outcome of kidney transplantation in HIV-infected recipients: a retrospective study. [2019]Kidney transplantation is a safe and effective option for HIV-positive (HIV+) patients. We conducted a retrospective study on HIV+ kidney transplant recipients who underwent transplantation from March 2008 to September 2016. Inclusion criteria for transplantation were CD4+ T-cell count ≥200 per mm3 and undetectable HIV load. The current study reports the outcome of 19 HIV+ recipients, mostly of Caucasian origin (79%) with a median age of 50 years (interquartile range [IQR], 42-52), who were followed up for a median period of 2.4 years (IQR, 1.2-4.6) after transplantation. Compared with HIV-negative (HIV-) controls, HIV+ recipients had similar one- and three-year graft and patient survival, but significantly lower five-year patient survival (P = 0.03). The differences in graft outcome became less evident with the analysis of death-censored graft survival rates. Cumulative incidence of allograft rejection at one year was 32.9%. Rates of infections were not particularly elevated and HIV replication remained well controlled in all but one patient. A high prevalence of metabolic and endocrine complications (68%) was reported after transplantation. Further studies are needed to evaluate long-term outcomes of HIV+ recipients who underwent kidney transplantation.
Kidney transplantation in human immunodeficiency virus-infected patients: a report of two cases and a review of the literatures. [2022]Human immunodeficiency virus (HIV) infection was traditionally considered an absolute contraindication for transplantation because of concerns about HIV disease progression due to immunosuppression. Since potent antiretroviral therapies (ARTs) have become widely available, the prognosis of HIV-infected kidney transplant recipients has dramatically improved. Recent results of prospective multicenter trials on kidney transplantation (KT) in HIV-positive candidates have demonstrated the success and challenges of transplantation in this population. Several studies have reported comparable patient and graft outcomes between HIV-infected and HIV-uninfected recipients after KT in the era of potent combined ARTs. We report two cases of HIV-infected patients who underwent KT at our hospital. In this paper, we present a detailed report of two cases and provide a short review of the existing literature.
Challenges of kidney transplantation in HIV positive recipients. [2020]Human immunodeficiency virus (HIV) infection has long been a contraindication to kidney transplantation due to transplant immunosuppression, HIV-associated renal dysfunction, and nephrotoxicity associated with antiretroviral therapy (ART). However, advances in antiretroviral therapies and transplant immunosuppression regimens have allowed patients to successfully undergo kidney transplantation. Emerging data has shown that kidney transplantation may be a viable option for appropriately selected HIV patients with end-stage renal disease (ESRD). In this review, we discuss the indications, immunosuppression protocols, and outcomes of kidney transplantation in HIV patients.