#Odesi plugin trial#

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By clicking on the Accept all cookies button, you give your consent to the use of all the cookies used in our website. We also use third party tracking and profiling cookies and identifiers to collect information about how you use the Site and to send you promotional messages in line with your online preferences. In particular, we use cookies and other identifiers to ensure you get the best experience on our website, to provide you with social media features and to analyze our traffic. This website uses technical cookies functional to the site's operation, anonymous statistical and, subject to your consent, third party analytical and profiling cookies. These regulatory approvals are a cornerstone on which further work can be built towards timely access to optimal antiretroviral therapies (ART) for children living with HIV around the world. Approval by the European Medicines Agency (EMA) for the first-ever dispersible tablet formulation of dolutegravir followed in January 2021. Food and Drug Administration (FDA) of the use of the dolutegravir adult film-coated tablet in children weighing more than 20kgs as well as the use of new ViiV Healthcare dolutegravir tablets for oral suspension in patients aged at least four weeks and weighing at least 3kg.

On June 2020, the preliminary results of this study led to approval by the U.S. ODYSSEY included a pharmacokinetics substudy in children 2 to 6 years of age. Penta was the sponsor of this study, with patients enrolled from Spain, South Africa, Thailand, United Kingdom, Zimbabwe, Portugal and Uganda.

#Odesi plugin trial#

ODYSSEY was a multi-centre, randomised clinical trial to assess the efficacy and toxicity of dolutegravir plus 2 NRTI versus standard of care among HIV positive children and adolescents. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART A randomised trial of dolutegravir (DGT)-based antiretroviral therapy vs.