Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:November 2015
End Date:June 2024
Contact:Christine Durand, MD
Email:cdurand2@jhmi.edu
Phone:410-955-5684

Use our guide to learn which trials are right for you!

Observational Study of HIV+ Deceased Donor Solid Organ Transplant for HIV+ Recipients

HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from
an HIV+ deceased donor will be followed to determine the safety and efficacy of this
practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected
(HIV-) donors will also be followed.

This is an observational study designed to evaluate safety and outcomes of solid organ
transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate
overall survival and graft survival compared to transplantation with an HIV- organ.

In addition the study will assess potential complications of organ transplant using HIV+
deceased donors - including but not limited to - HIV superinfection, incidence and severity
of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial
infections, and opportunistic infections.

Inclusion Criteria:

All individuals with end-stage organ disease and HIV infection who meet standard clinical
criteria for transplantation and the study inclusion and exclusion criteria will be
eligible for participation in the study.

1. Participant is able to understand and provide informed consent

2. Participant meets standard listing criteria for transplant.

3. Documented HIV infection (by any licensed ELISA and confirmation by Western Blot,
positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable
HIV-1 RNA).

4. Participant is > 18 years old.

5. Opportunistic Complications: None or previous history of protocol allowed
opportunistic infections or neoplasms with appropriate acute and maintenance therapy
and no evidence of active disease.

6. Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.

7. Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed
in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a
stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies
RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final
Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA
monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL)
should be < 50 copies, but this result can be documented outside the 16 week window
according to the judgement of the local clinical team and site investigator. Organ
recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ
failure or who have only recently started ART may have detectable viral load and still
be considered eligible if the study team is confident there will be a safe, tolerable,
and effective antiretroviral regimen to be used by the recipient once organ function
is restored after transplantation.

8. Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and
fungal prophylaxis as indicated.

Exclusion Criteria:

1. Participant has concomitant conditions that, in the judgment of the investigators,
would preclude transplantation or immunosuppression.

2. Opportunistic Complication History: Any history of progressive multifocal
leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration,
or primary Central Nervous System (CNS) lymphoma.

3. Participant has a history of any neoplasm except for the following: resolved Kaposi's
sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell
carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with
curative therapy and disease free for more than 5 years. History of renal cell
carcinoma requires disease free state for 2 years. History of leukemia and
disease-free duration will be per site policy.

4. Participant is pregnant or breastfeeding. Note: Participants who become pregnant
post-transplant will continue to be followed in the study and will be managed per
clinical practice. Women that become pregnant should not breastfeed.
We found this trial at
17
sites
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Anthony Amoroso, MD
Phone: 410-706-4607
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Nicole Turgeon, MD
Phone: 404-727-3257
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Christine Durand, MD
Phone: 410-955-5684
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Marcus Pereira, MD, MPH
Phone: 212-305-3839
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
?
mi
from
New York, NY
Click here to add this to my saved trials
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Ghady Haidar, MD
Phone: 412-648-6212
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Maheen Abidi, MD
Phone: 303-724-4930
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Avinash Agarwal, MD
Phone: 434-924-9370
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Carlos Santos, MD, MPHS
Phone: 312-942-5864
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Mario Spaggiari, MD
Phone: 312-675-9570
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Valentina Stosor, MD
Phone: 312-695-5085
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1441 North Beckley Avenue
Dallas, Texas 75203
Principal Investigator: Jose A. Castillo-Lugo, MD
Phone: 214-358-2300
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Oluwafisayo Adebiyi, MD
Phone: 317-944-4370
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Maricar Malinis, MD
Phone: 203-785-2073
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Sapna Mehta, MD
Phone: 646-754-1006
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials
445 E 69th St
New York, New York 10021
(212) 746-1067
Principal Investigator: Thangamani Muthukumar, MD
Phone: 212-746-4430
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
?
mi
from
New York, NY
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Sander Florman, MD
Phone: 212-659-8313
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Alexander Gilbert, MD
Phone: 202-444-3700
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
?
mi
from
Washington,
Click here to add this to my saved trials