HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
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
- Hiv
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental HIV D+/R+ |
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 80 |
|
|
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
Birmingham, Alabama 35294
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of California, Los Angeles
Los Angeles, California 90095
Los Angeles, California 90095
University of California, San Diego
San Diego, California 92103
San Diego, California 92103
University of California, San Francisco
San Francisco, California 94193
San Francisco, California 94193
Yale University School of Medicine
New Haven, Connecticut 06520-8022
New Haven, Connecticut 06520-8022
MedStar Georgetown Transplant Institute
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Miami Transplant Institute
Miami, Florida 33136
Miami, Florida 33136
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Illinois at Chicago
Chicago, Illinois 60612
Chicago, Illinois 60612
Ochsner Medical Center
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Johns Hopkins University
Baltimore, Maryland 21205
Baltimore, Maryland 21205
University of Maryland, Institute of Human Virology
Baltimore, Maryland 212101
Baltimore, Maryland 212101
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
New York University School of Medicine
New York, New York 10016
New York, New York 10016
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Weill Cornell Medical College
New York, New York 10065
New York, New York 10065
University of Cincinnati
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
Drexel University
Philadelphia, Pennsylvania 19102
Philadelphia, Pennsylvania 19102
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
UPMC-University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Methodist Health System Clinical Research Institute
Dallas, Texas 75203
Dallas, Texas 75203
University of Texas Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
University of Virginia
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
More Details
- NCT ID
- NCT03500315
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
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.