On World AIDS Day, UNSW’s Kirby Institute has been awarded a $A12 million grant from UNITAID to conduct a clinical trial to improve treatment options for people with HIV infection who experience treatment failure.
Established in 2006 by Brazil, Chile, France, Norway and the United Kingdom, UNITAID plays an important part in the global effort to defeat HIV, tuberculosis and malaria.
The D2EFT (Dolutegravir and Darunavir evaluation in adults failing therapy) trial is a multicentre, multinational, randomised trial in 610 HIV-infected people who have failed first-line antiretroviral therapy (ART).
There is an urgent and unmet need for a better regimen of combination antiretroviral therapy for use in second-line therapy.
“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 chief investigator of the trial, Professor Sean Emery, from UNSW’s Kirby Institute.
“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," Professor Emery said.
The D2EFT study 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.
The method: D2EFT is a randomised, open-label study recruiting participants from sites in 25 centres across four continents in Argentina, Chile, Colombia, India, Malaysia, Mexico, Peru, South Africa, Thailand and Zimbabwe. It will begin recruiting in mid-2017 and will be conducted over four years. Interim results will be presented in 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,” Professor Emery said.
Funded by UNITAID and led by UNSW’s Kirby Institute, the trial is also supported by ViiV Healthcare and Janssen Pharmaceuticals.