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Clinical trial tracking HIV-positive liver transplant outcomes begins

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The NIH announced the start of the first large-scale clinical trial to track liver transplants between HIV-positive donors and HIV-positive recipients.

The trial will evaluate liver recipients for potential transplant-related and HIV-related complications to determine the safety of the practice, the agency said.

Passed in 2013, the HIV Organ Policy Equity (HOPE) Act made it legal in the United States to transplant HIV-infected organs as part of a research study. A similar trial to evaluate the safety and efficacy of kidney transplants between HIV-positive donors and recipients began last year.

“Antiretroviral therapy has been incredibly successful in helping people with HIV live longer, healthy lives. As more people with HIV grow older, we see organ damage in this population linked to age, HIV and other infections,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a news release.

According to the NIH, the new trial will follow the clinical outcomes of 80 liver transplants in HIV-positive recipients. A control group of 40 recipients will receive livers from HIV-negative donors, and 40 will receive transplants from HIV-positive donors.

Researchers will monitor recipients for signs of organ rejection or failure, failure of previously effective anti-HIV medications and other HIV-associated complications, the NIH said. They also will observe psychological and social responses, changes to reservoirs of latent HIV and watch for development of HIV superinfections.

“The HOPE in Action Multicenter Liver Study will allow researchers to evaluate the safety and efficacy of transplanting livers from donors with HIV to HIV-positive recipients. This strategy has the potential to both improve the well-being of those with HIV and increase the overall supply of transplantable livers,” Fauci said. – by Erin Michael

Reference:

NIH. NIH clinical trial to track outcomes of liver transplantation from HIV-positive donors to HIV-positive recipients. Available at: https://www.nih.gov/news-events/news-releases/nih-clinical-trial-track-outcomes-liver-transplantation-hiv-positive-donors-hiv-positive-recipients. Accessed on: February 14, 2019.

Disclosure: Fauci reports no relevant financial disclosures.