Kidney Transplantation for HIV

Recruiting at 13 trial locations

Overseen By Christine Durand, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Breastfeeding, PML, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

200 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 6 7 8 9}

How 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. ^{1 2 3 10 11}

Research Team

Christine Durand, MD

Principal Investigator

Johns Hopkins University

Eligibility 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

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.

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)

Treatment Details

Interventions

• Kidney Transplantation

Trial Overview 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.

Participant Groups

Group I: HIV D-/R+ Experimental Treatment 1 Intervention

People living with HIV who receive kidneys from deceased donors without HIV

Group II: HIV D+/R+ Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

In a study of 28 HIV-infected patients who underwent kidney transplantation, the procedure was found to be safe, with an 82.1% survival rate and all patients achieving undetectable HIV RNA levels at the last follow-up.

The study noted a high incidence of acute rejection (19 rejections in 16 patients), but the use of integrase inhibitors in antiretroviral therapy helped reduce potential drug interactions with immunosuppressive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of kidney transplantation in HIV-infected recipients under combination antiretroviral therapy: a single-cohort experience (Brescia, Northern Italy). Izzo, I., Casari, S., Bossini, N., et al.[2018]

HIV-positive kidney transplant recipients have a significantly higher risk of acute rejection (AR) and graft loss compared to HIV-negative recipients, but this risk is notably reduced when they receive antithymocyte globulin (ATG) induction therapy.

Sirolimus-based maintenance therapy is associated with a higher risk of AR in HIV-positive patients, suggesting that calcineurin inhibitor-based regimens may be safer and more effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppression regimen and the risk of acute rejection in HIV-infected kidney transplant recipients. Locke, JE., James, NT., Mannon, RB., et al.[2022]

In a review of 12 case series involving 254 HIV-positive kidney transplant recipients on highly active antiretroviral therapy (HAART), the 1-year survival rate was high at 93%, indicating that kidney transplantation is a safe option for these patients.

While organ rejection occurred in 36% of patients and infectious complications in 29%, the overall outcomes suggest that with proper immunosuppression protocols, kidney transplantation can be effectively managed in HIV-positive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney transplants in HIV-positive recipients under HAART. A comprehensive review and meta-analysis of 12 series. Landin, L., Rodriguez-Perez, JC., Garcia-Bello, MA., et al.[2010]

In a study of 27 HIV-infected individuals who received kidney transplants with rabbit anti-thymocyte globulin (rATG) induction, the five-year rate of de novo malignancy was 29%, indicating a significant risk of cancer development post-transplant.

The use of rATG induction was associated with a low rate of acute rejection (17%) and favorable patient survival (85%), but also highlighted the need for careful monitoring for BK viremia, which occurred in 22% of participants, to improve overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of rabbit anti-thymocyte globulin induction immunosuppression in HIV-infected kidney transplant recipients. Al Jurdi, A., Liu, EC., Salinas, T., et al.[2023]

In a study of 150 HIV-infected patients who underwent kidney transplantation, the 1-year and 3-year patient survival rates were high at 94.6% and 88.2%, respectively, indicating that kidney transplantation can be safe and effective for this population.

However, the study revealed unexpectedly high rejection rates of 31% at 1 year and 41% at 3 years, highlighting the need for improved immunotherapy strategies in managing transplant rejection among HIV-infected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of kidney transplantation in HIV-infected recipients. Stock, PG., Barin, B., Murphy, B., et al.[2022]

A 60-year-old Canadian man with HIV successfully received a kidney transplant from an HIV-positive donor, demonstrating that such transplants can be viable options for carefully selected patients.

Post-transplant outcomes were excellent, with good kidney function and controlled HIV replication, highlighting the importance of using antiretroviral medications that do not interact with immunosuppressive drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Canadian Case Report of Kidney Transplantation From an HIV-Positive Donor to an HIV-Positive Recipient. Ambaraghassi, G., Cardinal, H., Corsilli, D., et al.[2022]

This case report describes a successful kidney transplantation from an HIV-positive living donor to an HIV-positive recipient, marking one of the earliest documented instances of such a procedure, which highlights the evolving perspective on HIV in the context of organ donation.

Both the donor and recipient were on effective antiretroviral therapy (ART) with well-controlled viral loads, suggesting that with proper management, HIV-positive individuals can safely participate in kidney donation and transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In sickness and in health: Living HIV positive kidney donation from a wife to her husband, with 7 years' post-transplant follow-up. Grupper, A., Goykhman, Y., Baruch, R., et al.[2020]

Contemporary studies show that renal transplantation is a safe and effective option for HIV+ patients with end-stage renal disease, offering similar survival rates for both patients and transplanted kidneys compared to those without HIV.

Despite the success of kidney transplants in HIV+ patients, there are unique challenges such as higher rates of acute rejection and drug interactions, which are important considerations in ongoing clinical research and trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney transplantation for HIV-positive patients. Sawinski, D.[2018]

Kidney transplantation is a safe and effective option for HIV-positive patients, with similar one- and three-year graft and patient survival rates compared to HIV-negative controls, although five-year patient survival was significantly lower.

Despite a 32.9% incidence of allograft rejection within the first year, infection rates were not significantly higher, and HIV replication was well controlled in most patients, though a high prevalence of metabolic and endocrine complications (68%) was observed post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of kidney transplantation in HIV-infected recipients: a retrospective study. Alfano, G., Mori, G., Fontana, F., et al.[2019]

With the advent of effective antiretroviral therapies (ARTs), HIV-positive patients can now successfully undergo kidney transplantation (KT), showing improved outcomes compared to previous concerns about disease progression due to immunosuppression.

Recent multicenter trials indicate that patient and graft outcomes for HIV-infected kidney transplant recipients are comparable to those of HIV-uninfected recipients, highlighting the viability of transplantation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney transplantation in human immunodeficiency virus-infected patients: a report of two cases and a review of the literatures. Hwang, HP., Yu, HC., Kang, KP., et al.[2022]

Recent advancements in antiretroviral therapies and immunosuppression protocols have made kidney transplantation a viable option for selected HIV patients with end-stage renal disease (ESRD).

Emerging data suggests that appropriately selected HIV patients can successfully undergo kidney transplantation, overcoming previous concerns about immunosuppression and HIV-related kidney issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges of kidney transplantation in HIV positive recipients. Alameddine, M., Jue, JS., Zheng, I., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of kidney transplantation in HIV-infected recipients under combination antiretroviral therapy: a single-cohort experience (Brescia, Northern Italy). [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Immunosuppression regimen and the risk of acute rejection in HIV-infected kidney transplant recipients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Kidney transplants in HIV-positive recipients under HAART. A comprehensive review and meta-analysis of 12 series. [2010]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Complications of rabbit anti-thymocyte globulin induction immunosuppression in HIV-infected kidney transplant recipients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of kidney transplantation in HIV-infected recipients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

First Canadian Case Report of Kidney Transplantation From an HIV-Positive Donor to an HIV-Positive Recipient. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

In sickness and in health: Living HIV positive kidney donation from a wife to her husband, with 7 years' post-transplant follow-up. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Kidney transplantation for HIV-positive patients. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Clinical outcome of kidney transplantation in HIV-infected recipients: a retrospective study. [2019]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Kidney transplantation in human immunodeficiency virus-infected patients: a report of two cases and a review of the literatures. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Challenges of kidney transplantation in HIV positive recipients. [2020]