HIV Infection
Conditions
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.
Interventions
OTHERHIV-infected deceased donor organ
HIV-infected deceased donor organ transplant
Sponsors
University of Colorado, Denver
Yale University
Georgetown University
Emory University
Rush University Medical Center
University of Illinois at Chicago
Indiana University
University of Maryland
Columbia University
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
University of Pittsburgh Medical Center
Methodist Health System
Northwestern University
NYU Langone Health
University of Virginia
Washington University School of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | One year | Patient survival at one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Antiretroviral resistance and X4 tropic virus | through study completion, up to 4 years | incidence of new antiretroviral drug resistance and/or X4 tropic virus |
| 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 |
| Surgical complications | within the first 3 months | incidence of surgical and vascular transplant complications |
| Graft survival | one year, two years, 3 years, 4 years | Transplanted organ function |
| Incidence of post-transplant Malignancy | through study completion, up to 4 years | incidence of post-transplant malignancies |
| 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 |
| 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 |
| Immune activation | measured at 3 months, 6 months, year 1, year 2, year 3, year 4 | Cytokine levels |
| Recurrent HIV-associated nephropathy | through study completion, up to 4 years | incidence of recurrent HIV-associated nephropathy in kidney recipients |
Countries
United States
Outcome results
None listed