HIV
Conditions
Brief summary
This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors 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 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 HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).
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 liver or simultaneous liver kidney (SLK) transplant. * Participant or legally authorized representative (in accordance with Johns Hopkins Medicine Institutional Review Board (IRB) and local IRB policy) 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. * Most recent HIV-1 RNA \< 50 copies RNA/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \> 200 copies/mL. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
Exclusion criteria
* Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \> 1 month duration, or prior 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 |
|---|---|---|
| Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT | From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant) | Cumulative incidence of composite event of opportunistic infection or cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant survival | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Time to event (death) |
| Graft survival | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Time to event (graft loss) |
| Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Cumulative incidence of infections |
| Incidence and type of post-transplant cancer as determined by local pathology | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Cumulative incidence of cancer determined by local pathology |
| Serious adverse events post-transplant | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Cumulative incidence of serious adverse events |
| Incidence of rejection events post-transplant | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Cumulative incidence of rejection events |
| Graft function over time measured by fibrosis-4 index and Aspartate Aminotransferase (AST) to Platelet Ratio Index | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Mean value of graft function |
| Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Cumulative incidence of HIV-breakthrough and HIV persistent viral failure |
| Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) | Cumulative incidence of new resistance and/or X4 tropic virus based on local testing |
| Incidence of surgical and vascular transplant complications during the first year post-transplant | From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant) | Cumulative incidence of complications |
Countries
United States
Contacts
CONTACTChristine Durand, MD
PRINCIPAL_INVESTIGATORChristine Durand, MD
Johns Hopkins University
Outcome results
None listed