Expanding HOPE Liver
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
This is a prospective, multicenter clinical study. The objective is to determine whether a liver transplant from a deceased donor with HIV is associated with an increased risk of opportunistic infection and cancer. Adults with Human Immunodeficiency Virus (HIV) in need of a liver or simultaneous liver-kidney (SLK) transplant who meet study-specified criteria will be offered enrollment in the study. The analytic plan includes an observational cohort of liver and SLK transplant recipients from prior HOPE in Action studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
Participant is ≥ 18 years old
Disqualifiers
Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month, or primary Central Nervous System (CNS) lymphoma
Participant is pregnant or breastfeeding. Note: Participants who become pregnant post-transplant will be followed on study and managed per local site practice
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
Trial population
In order to have maximum power to precisely estimate the risk of opportunistic infection or cancer attributable to donor HIV status, this trial population (n=80) will be combined with prior HOPE in Action cohorts: HOPE Pilot; HOPE Liver U01 RTB-009, HOPE Liver Long Term Follow Up (LLTF) study. The study will use data from HOPE Pilot and HOPE Liver U01 RTB-009 through end of follow up and participants will also be approached for enrollment to continue long-term follow-up for up to 10 years in the HOPE LLTF study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: HIV D-/R+ Arm
Group B: HIV D+/R+ Arm
Trial outcomes
Primary outcomes
1
Incidence of a composite event of opportunistic infection or cancer in Human Immunodeficiency Virus (HIV)-infected donor (HIV D+)/recipient (R+) compared with HIV-uninfected donor (HIV D-)/recipient (R+) liver transplant recipients
Time frame
From transplant through 4 years post-transplantSecondary outcomes
1
Overall survival measured as time from transplantation to death from any cause
Time frame
From transplant through 4 years post-transplant2
Graft survival measured as time from transplantation to graft failure
Graft failure is defined as any of the following events: re-transplantation; death; allograft nephrectomy; initiation of post-donation chronic dialysis (SLK only).
Time frame
From transplant through 4 years post-transplant3
Incidence of bacterial infections post-transplant
Time frame
From transplant through 4 years post-transplant4
Incidence of post-transplant cancer
As determined by local pathology
Time frame
From transplant through 4 years post-transplantSponsors and contacts
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Source ClinicalTrials.gov