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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    160
  • sponsor
    Johns Hopkins University
Updated on 13 August 2021
body mass index
HIV Infection
opportunistic infection
HIV Vaccine
hiv-1 rna measurement

Summary

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.

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.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment HIV D+/R+
Clinical Study IdentifierNCT03500315
SponsorJohns Hopkins University
Last Modified on13 August 2021

Eligibility

Yes No Not Sure

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)
No living donor available
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/L 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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