University of New South Wales: The ENCORE 1 Study

Project Timeline

April 2011 – December 2011

“ENCORE (for Evaluation of Novel Concepts in Optimization of antiRetroviral Efficacy) was a program originally designed to examine the safety and efficacy of lower doses of important antiretroviral drugs (ART). This was intended to allow donors, governments and non-government organisations to purchase more drugs, and also to ease the pressure on manufacturing capacity to meet the growing global demand for ART. The process of revising dose guidelines is called dose optimisation and is expected to lead to greater effectiveness and efficiencies in funding for treatment, care and prevention work. The program comprised three individual studies: ENCORE1, ENCORE2 and ENCORE3.

ENCORE1, was conducted in 38 clinical sites in 13 countries in Africa, Asia, Australia, Europe and Latin America. This large international, multicentre, randomised double-blind placebo-controlled trial has recruited 630 trial participants to compare the safety and effectiveness of a reduced dose of HIV therapy efavirenz, or EFV (400mg compared to 600mg)in combination with two other standard ART drugs in HIV-positive people who have not previously taken HIV therapy.The primary analyses will determine if lower doses are just as effective as standard doses. Further analyses will address a range of other issues including safety, tolerability and quality of life.”

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