HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

Completed · Not applicable

Conditions studied: Hiv

In brief

The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

Key facts

Study ID

NCT03500315

Run by

Johns Hopkins University

People needed

209

Starts

2018-04-19

Expected to finish

2024-05-01

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant meets the standard criteria for kidney transplant at the local center.
• Participant is able to understand and provide informed consent.
• Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards.
• Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).
• Participant is ≥18 years old.
• Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease.
• Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.
• HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements >200 copies/mL.
• Participant is willing to comply with all medication related to their transplant and HIV management.
• For participant with a history of aspergillus colonization or disease, no evidence of active disease.
• The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management.
• All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control.
• Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.

You may not qualify if…

• Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.
• 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 or may impact the quality or interpretation of the data obtained from the study.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• MedStar Georgetown Transplant Institute — Washington D.C., District of Columbia, United States
• Miami Transplant Institute — Miami, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Maryland, Institute of Human Virology — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• New York University School of Medicine — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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