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Procedure

Kidney Transplantation for HIV

N/A
Recruiting
Led By Christine Durand, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is able to understand and provide informed consent
Participant is ≥ 18 years old
Must not have
Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month, or primary central nervous system (CNS) lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study rejection in HIV-positive transplant recipients who receive kidneys from donors with or without HIV to improve understanding of the process. "This trial aims to study how rejection occurs in HIV-positive transplant

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with kidney transplants may include infection risk due to immunosuppression, possible organ rejection, medication side effects, and complications related to surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can give my consent.
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I am 18 years old or older.
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I am eligible for a kidney transplant according to local guidelines.
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My BMI is 21 or above and I don't have significant weight loss due to HIV.
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My CD4+ T-cell count is 200 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had PML, long-term cryptosporidiosis, or brain lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from transplant through end of follow up (at least 1 year, up to 4 years post-transplant)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from transplant through end of follow up (at least 1 year, up to 4 years post-transplant) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative incidence of death and allograft rejection.
Secondary study objectives
Graft function over time measured by eGFR trajectory
Graft survival
Incidence and causes of chronic kidney disease post-transplant
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,323 Previous Clinical Trials
5,364,568 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,414 Total Patients Enrolled
Christine Durand, MDPrincipal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
645 Total Patients Enrolled
~133 spots leftby Sep 2028