Recruiting

Transplant Recipients

Sponsor:

Johns Hopkins University

Code:

NCT07665372

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HIV D+/R+

HIV D-/R+

Study Details

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.

Conditions

HIV

Study ID

NCT07665372

Start date

Nov, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HIV D+/R+

People living with HIV who receive livers from deceased donors with HIV

experimental: HIV D-/R+

People living with HIV who receive livers from deceased donors without HIV

Interventions

HIV D+/R+

Receipt of liver transplant from a deceased donor with HIV

HIV D-/R+

Receipt of liver transplant from a deceased donor without HIV

Primary outcome measure

  • Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT [ Time Frame: From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant) ]

Central Contacts and Locations

Central contacts

Christine Durand, MD

410-614-6702ChristineDurand@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Christine Durand, MD

ChristineDurand@jhmi.edu

Principal Investigator:

Christine Durand, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Sander Florman, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-09.