The first large-scale clinical trial to study kidney transplantation between people with HIV has begun at clinical centers across the United States, according to a press release from the NIH.
The HOPE in Action Multicenter Kidney Study aims to determine the safety of this practice by evaluating kidney recipients for potential transplant-related and HIV-related complications following surgery. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
“Highly effective antiretroviral therapy and new antiviral drugs to treat hepatitis C have dramatically improved the health of people living with HIV, such that a young person newly diagnosed with HIV today can expect to live a nearly normal lifespan,” Anthony S. Fauci, MD, director of NIAID, said in the release. “The HOPE Act of 2013 opened the door for researchers to explore a potential new source of donor organs for those living with HIV — a population with a significant and growing need for transplants. This study offers a chance to improve the health of those living with HIV and increase the overall supply of transplantable organs.”
The HOPE in Action Multicenter Kidney Study is the first of its type in the United States to receive IRB approval by following the research criteria and guidance mandated by the HOPE Act of 2013. The study will track the clinical outcomes of 160 kidney transplants. All transplant recipients in the study will be living with HIV; 80 of them will receive kidneys from deceased donors who had HIV and 80 will receive kidneys from HIV-uninfected deceased donors serving as the control group. Health care teams and study participants will be made aware of the HIV status of the organ donor.