The study is the first study of its type in the United States to receive Institutional Review Board approval. Researchers will follow the outcomes of 160 kidney transplants. All study participants will be living with HIV; 80 will receive kidneys from donors who had HIV, and 80 will receive kidneys from HIV-negative donors and serve as controls.
People living with HIV have a higher risk of endstage liver and kidney diseases from damage caused by HIV and its comorbidities, such as hepatitis B and C, hypertension, diabetes, and toxicities associated with antiretroviral drugs.
“A kidney transplant can mean a second chance at a normal life for a person with endstage renal disease who may otherwise needs hours-long dialysis sessions, multiple times per week,” said Christine Durand, MD, assistant professor of medicine, Johns Hopkins University, and principal investigator of the study, in a statement.
While transplants like these have been successfully accomplished in South Africa since 2008, they were illegal in the US until the implementation of the HIV Organ Policy Equity (HOPE) Act in 2013. The act allows US transplant teams with approved research protocols to transplant organs from donors with HIV into qualified recipients with HIV and endstage organ failure. Researchers expect this will shorten the wait time for those with HIV waiting to receive a transplant.
Throughout the study, researchers will closely monitor participants for signs of organ rejection, organ failure, failure of previously effective HIV treatments, and HIV-related complications. They will also track participants’ psychological and social responses, changes in their reservoirs of latent HIV, and the potential development of HIV superinfection.
“Not only is the quality of life improved for patients who undergo kidney transplantation, they also have fewer complications and longer lifespans compared to those who remain on dialysis,” said Daniel Rotrosen, MD, director, National Institute of Allergy and Infectious Diseases’ (NIAID’s) Division of Allergy, Immunology, and Transplantation, which will oversee the study, in a statement. “An important question is whether those living with HIV will also receive these same clinical benefits.”
Those participating in the study are also eligible to co-enroll in a separate NAID-supported study, Impact of CCR5 Blockade in HIV+ Kidney Transplant recipients. The phase 2 study will evaluate the safety and immune response to the anti-HIV drug maraviroc in kidney recipients with HIV and determine if the drug reduces rates of kidney rejection in the patient population.
Author: Jaime Rosenberg