Hiv
Conditions
Brief summary
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Detailed description
Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study. Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of their HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of their HIV. This study will look to better understand rejection in transplant recipients with HIV (HIVR+) who receive kidneys from donors with HIV (HIVD+) vs without HIV (HIVD-).
Interventions
Sponsors
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant meets local criteria for kidney transplant. * Participant is able to understand and provide informed consent. * Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA. * Participant is ≥ 18 years old. * HIV-1 RNA \< 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. * Participant is not suffering from significant wasting (e.g. body mass index \<21) thought to be related to HIV disease.
Exclusion criteria
* Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month, 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 from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of death and allograft rejection. | From date of transplant to end of year 1 | Proportion of participants who die or have graft rejection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant survival | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Time to event (death) |
| Graft survival | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Time to event (graft loss) |
| Type and severity of graft rejection | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Based on Banff scoring criteria (kidney) for T cell- and antibody-mediated rejection (currently Banff 2019) |
| Time to first rejection | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Time to event (first rejection) |
| Rate of rejection events over time | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Count of rejection events |
| Graft function over time measured by eGFR trajectory | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Estimated glomerular filtration rate, calculated centrally based on local testing results |
| Incidence of HIV viremia post-transplant | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Cumulative incidence of HIV viremia based on local testing |
| Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Cumulative incidence of new resistance and/or X4 tropic virus based on local testing |
| Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Cumulative incidence of infections |
| Incidence of surgical and vascular transplant complications post-transplant | In the first year post-transplant | Cumulative incidence of complications |
| Incidence and causes of chronic kidney disease post-transplant | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Cumulative incidence of chronic kidney disease (eGFR\<60 for more than 3 months) |
| Incidence of post-transplant malignancies | From transplant through end of follow up (at least 1 year, up to 4 years post-transplant) | Cumulative incidence of malignancies |
| Incidence of de novo donor specific antibody (DSA) | At month 12 post-transplant | Based on central testing |
Countries
United States
Contacts
CONTACTChristine Durand, MD
PRINCIPAL_INVESTIGATORChristine Durand, MD
Johns Hopkins University
Outcome results
None listed