Expanding HOPE Liver

Conditions

• HIV Infection
• Liver Transplant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Aug 21, 2026

Start date

Oct 15, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2030

Completion

Aug 31, 2030

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: HIV D-/R+ Arm
  Participants who receive a liver or SLK from a donor without HIV (D-) will be in this arm. Participants who accept an HIV suspected false positive (FP) organ will be part of the D-/R+ arm once confirmatory testing confirms the negative HIV status of the donor. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant
• Arm: HIV D+/R+ Arm
  Prospective cohort of transplant recipients who receive a liver or SLK from a donor with HIV (D+) will be in the HIV D+/R+ arm. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant

Primary Outcome Measure

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-transplant ]

Locations (2)

Find similar trials in Baltimore, MD

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