HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

Johns Hopkins University

Status: Completed

Conditions: Hiv

Treatments: Other: HIV D+/R+

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03500315

U01AI134591 (U.S. NIH Grant/Contract)

IRB00141138

Details and patient eligibility

About

The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

Full description

This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant meets the standard criteria for kidney transplant at the local center.
• Participant is able to understand and provide informed consent.
• Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards.
• Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).
• Participant is ≥18 years old.
• Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease.
• Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.
• HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements >200 copies/mL.
• Participant is willing to comply with all medication related to their transplant and HIV management.
• For participant with a history of aspergillus colonization or disease, no evidence of active disease.
• The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management.
• All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control.
• Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.

Exclusion criteria

• Participant has a history of progressive multifocal leukoencephalopathy (PML) or 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 or may impact the quality or interpretation of the data obtained from the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 3 patient groups

HIV D+/R+

Experimental group

Description:

HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 100

Treatment:

Other: HIV D+/R+

HIV D-/R+

No Intervention group

Description:

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 100

HIV D-/R+ (observational)

No Intervention group

Description:

HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200