Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).
  • No living donor available.
  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HIV D+/R+
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 80
  • Other: HIV D+/R+
    Kidney from an HIV-infected deceased donor
No Intervention
HIV D-/R+
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 80
No Intervention
HIV D-/R+ (observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Shikha Mehta, MD
205-934-1801
smehta@uabmc.edu

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Emmanouil Giorgakis, MD
egiorgakis@uams.edu

University of California, Los Angeles
Los Angeles, California 90095
Contact:
Joanna Schaenman, MD, PhD
310-825-7225
jschaenman@mednet.ucla.edu

University of California, San Diego
San Diego, California 92103
Contact:
Saima Aslam, MD
saslam@ucsd.edu

University of California, San Francisco
San Francisco, California 94193
Contact:
Ada Chao
415-476-2575
ada.chao@ucsf.edu

Yale University School of Medicine
New Haven, Connecticut 06520-8022
Contact:
Maricar Malinis, MD
203-785-2073
maricar.malinis@yale.edu

MedStar Georgetown Transplant Institute
Washington, District of Columbia 20007
Contact:
Alexander Gilbert, MD
202-444-2072
alexander.j.gilbert@gunet.georgetown.edu

Miami Transplant Institute
Miami, Florida 33136
Contact:
Michele I. Morris, MD
305-243-4598
mmorris2@med.miami.edu

Emory University
Atlanta, Georgia 30322
Contact:
Rachel Friedman-Moraco, MD
rfried6@emory.edu

Northwestern University
Chicago, Illinois 60611
Contact:
Valentina Stosor, MD
312-695-5085
v-stosor@northwestern.edu

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Carlos A. Santos, MD, MPHS
312-563-6372
carlos_a_santos@rush.edu

University of Illinois at Chicago
Chicago, Illinois 60612
Contact:
Mario Spaggiari, MD
312-675-9570
mspaggia@uic.edu

Ochsner Medical Center
New Orleans, Louisiana 70121
Contact:
Jonathan Hand, MD
jonathan.hand@ochsner.org

Johns Hopkins University
Baltimore, Maryland 21205
Contact:
Christine Durand, MD
410-614-0648
christinedurand@jhmi.edu

University of Maryland, Institute of Human Virology
Baltimore, Maryland 212101
Contact:
Jennifer Husson, MD, MPH
410-706-8614
jhusson@ihv.umaryland.edu

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Nahel Elias, MD
617-726-0174
elias.nahel@mgh.harvard.edu

New York University School of Medicine
New York, New York 10016
Contact:
Sapna Mehta, MD
646-754-1006
sapna.mehta@nyumc.org

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Sander Florman, MD, FACS
212-659-8313
sander.florman@mountsinai.org

Columbia University Medical Center
New York, New York 10032
Contact:
Cristina M. Falo, PhD
212-305-3839
cf2427@cumc.columbia.edu

Weill Cornell Medical College
New York, New York 10065
Contact:
Catherine B. Small, MD
914-552-5960
cbs9003@med.cornell.edu

University of Cincinnati
Cincinnati, Ohio 45267
Contact:
Senu Apewokin, MD, FACP
513-558-4704
apewoksu@ucmail.uc.edu

Drexel University
Philadelphia, Pennsylvania 19102
Contact:
Dong Heun Lee, MD
215-762-4697
dong.lee@drexelmed.edu

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Emily Blumberg, MD
215-662-7066
blumbere@pennmedicine.upenn.edu

UPMC-University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Ghady Haidar, MD
412-648-6212
haidarg@upmc.edu

Methodist Health System Clinical Research Institute
Dallas, Texas 75203
Contact:
Jose A. Castillo-Lugo, MD
castilloj@dneph.com

University of Texas Southwestern Medical Center
Dallas, Texas 75390
Contact:
David Wojciechowski, DO
214-645-7846
david.wojciechowski@utsouthwestern.edu

University of Virginia
Charlottesville, Virginia 22908
Contact:
Avinash Agarwal, MD
434-924-9462
aa4vb@hscmail.mcc.virginia.edu

More Details

NCT ID
NCT03500315
Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Christine Durand, MD
410-955-5684
cdurand2@jhmi.edu

Detailed Description

This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.