August 11/25, 2003

Key Clinical, Ethical, and Policy Issues in the Evaluation of the Safety and Effectiveness of Solid Organ Transplantation in HIV-Infected Patients

Author Affiliations

Copyright 2003 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2003

Arch Intern Med. 2003;163(15):1773-1778. doi:10.1001/archinte.163.15.1773

PATIENTS WITH human immunodeficiency virus (HIV) infection are at significant risk for end-stage kidney and liver disease, and are therefore potential candidates for solid organ transplantation.115 However, they have been considered poor transplant candidates. In this era of effective antiretroviral therapy, preliminary experience with transplantation appears promising, although critical clinical and ethical questions remain. Thus, it is timely to perform a safety and efficacy study of transplantation in HIV-infected patients. Key clinical issues in the design of such a study include consideration of the patients' history of opportunistic complications and hepatitis C coinfection, and their ability to tolerate antiretroviral drugs when defining selection criteria for study subjects. The ethical questions of resource allocation and the risks and benefits associated with living and cadaveric organ donation must also be carefully considered. To address the concerns of utility and effectiveness for each intervention, the minimum acceptable patient and graft survival rates must be chosen on the basis of current transplant practices. Clinical outcomes data from well-designed trials are critical to ensure adherence to the principle of justice in the organ allocation process.

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