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Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)

ConditionHIV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HIV D+/R+

    Other intervention

    Receipt of liver transplant from a deceased donor with HIV

  • HIV D-/R+

    Other intervention

    Receipt of liver transplant from a deceased donor without HIV

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: HIV D+/R+Experimental treatment 1 intervention
Group B: HIV D-/R+Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT

Cumulative incidence of composite event of opportunistic infection or cancer

Time frame
From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)

Secondary outcomes

1

Participant survival

Time to event (death)

Time frame
From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
2

Graft survival

Time to event (graft loss)

Time frame
From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
3

Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant

Cumulative incidence of infections

Time frame
From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)
4

Incidence and type of post-transplant cancer as determined by local pathology

Cumulative incidence of cancer determined by local pathology

Time frame
From transplant through end of follow up (at least 6 months, up to 4 years post-transplant)

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: