Sydney, Australia– UNSW’s Kirby Institute has been awarded a $12 million grant (AUD) from UNITAID to conduct aclinical trial to improve treatment options for people with HIV infection who experience treatment failure.
TheD2EFTtrial is a multicentre, multinational, randomised trial in 610 people with HIV who have failed first-line antiretroviral therapy (ART).
“In resource-limited settings, up to 10-15 per cent of all people who start ART every year experience treatment failure, requiring them to switch to a second-line of drug therapy,” said Professor Sean Emery, Chief Investigator of the trial. “However, current recommendations for second-line treatment regimens are both complex and economically unsustainable in resource-limited settings, where the vast majority of people with HIV live. There is an urgent and unmet need for a better regimen of combination antiretroviral therapy (cART) for use in second-line therapy.”
The D2EFTstudy will compare an alternative second-line regimen of therapy using two drugs (dolutegravir + ritonavir-boosted darunavir) versus the recommended standard of care antiretroviral regimens. Researchers will also evaluate the cost-effectiveness of each treatment regimen in diverse clinical settings.
Participants will be recruited through 25 investigational centres in 10 countries on four continents. The trial will begin recruiting in mid-2017 and will be conducted over four years. Interim results will be presented mid-2019.
“If the experimental regimen of cART is shown to be clinically superior or equal to the currently recommended regimens of therapy, then there will be substantial evidence to support modification of global recommendations, which will impact the treatment of millions of people in resource-limited settings,” said Professor Emery.
D2EFTis funded by UNITAID and led by UNSW’s Kirby Institute. The study is supported by ViiV Healthcare and Janssen Pharmaceuticals for donation of the study drug.
Laurie Legere, Media and Communications Manager, Kirby Institute
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About the Kirby Institute
The Kirby Institute is a leading global research institute dedicated to the prevention and treatment of infectious diseases, with a particular focus on HIV, viral hepatitis and sexually transmissible infections.
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