Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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/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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HIV D+/R+
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 80
  • Other: HIV D+/R+
    Kidney from an HIV-infected deceased donor
No Intervention
HIV D-/R+
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 80
No Intervention
HIV D-/R+ (observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Shikha Mehta, MD
205-934-1801
smehta@uabmc.edu

More Details

Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Christine Durand, MD
410-955-5684
cdurand2@jhmi.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.