Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
- Conditions
- HIV Infection
- Interventions
- Other: HIV-infected deceased donor organ
- Registration Number
- NCT02602262
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
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.
- Participant is able to understand and provide informed consent
- Participant meets standard listing criteria for transplant.
- 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).
- Participant is > 18 years old.
- 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.
- Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.
- 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.
- Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.
- Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
- Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary Central Nervous System (CNS) lymphoma.
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV D+/R+ HIV-infected deceased donor organ HIV-infected individuals who accept an organ from an HIV-infected deceased donor
- Primary Outcome Measures
Name Time Method Survival One year Patient survival at one year
- Secondary Outcome Measures
Name Time Method Immune activation measured at 3 months, 6 months, year 1, year 2, year 3, year 4 Cytokine levels
Graft rejection One year Incidence and severity of organ rejection
HIV disease progression through study completion, up to 4 years Incidence of virologic breakthrough or failure
Surgical complications within the first 3 months incidence of surgical and vascular transplant complications
Incidence of bacterial, fungal, viral, and other opportunistic infection through study completion, up to 4 years incidence of bacterial, fungal, viral, and other opportunistic infections
Incidence of post-transplant Malignancy through study completion, up to 4 years incidence of post-transplant malignancies
Graft survival one year, two years, 3 years, 4 years Transplanted organ function
Incidence of HIV superinfection in blood and/or tissue measured at 3 months, 6 months, year 1, year 2, year 3, year 4 Incidence of HIV superinfection in blood and/or tissue
Antiretroviral resistance and X4 tropic virus through study completion, up to 4 years incidence of new antiretroviral drug resistance and/or X4 tropic virus
HIV latent reservoir measured at 3 months, 6 months, year 1, year 2, year 3, year 4 Frequency of infected CD4 T cells in blood
Recurrent HIV-associated nephropathy through study completion, up to 4 years incidence of recurrent HIV-associated nephropathy in kidney recipients
Trial Locations
- Locations (18)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Methodist Health System
🇺🇸Dallas, Texas, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Maryland, Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States