Clinical trial · Interventional
Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)
HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes
NCT07665372CI-TRIAL-00116079recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIV D+/R+ | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIV D+/R+
- description
- People living with HIV who receive livers from deceased donors with HIV
- interventionNames
- Other: HIV D+/R+
- type
- EXPERIMENTAL
- label
- HIV D-/R+
- description
- People living with HIV who receive livers from deceased donors without HIV
- interventionNames
- Other: HIV D-/R+
Primary outcomes (1)
- measure
- Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT
- timeFrame
- From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.