World Health Organization (WHO) guidelines recommend immediate ART for all adults and children living with HIV. Challenges encountered include: (i) running the trial across high- to low-income countries with differing frequencies of standard-of-care viral load monitoring (ii) evaluating pragmatic DTG dosing in PK sub-studies alongside FDA- and EMA-approved dosing and subsequently transitioning participants to new recommended doses (iii) delays in dosing information for children weighing 3 to < 14 kg and rapid recruitment of ART-naïve older/heavier children, which led to capping recruitment of participants weighing ≥35 kg in ODYSSEY A and extending recruitment (above 700) to allow for ≥60 additional children weighing between 3 to < 14 kg with associated PK (iv) a safety alert associated with DTG use during pregnancy, which required a review of the safety plan for adolescent girls. 128 (18%) had WHO stage 3 and 60 (8%) WHO stage 4 disease. 362 (51%) participants were male median age at enrolment was 12.2 years. 47% of children were enrolled in Uganda, 21% Zimbabwe, 20% South Africa, 9% Thailand, 4% Europe. The Creative Commons Public Domain Dedication waiver ( ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.īetween September 2016 and June 2018, 707 children weighing ≥14 kg were enrolled including 311 ART-naïve children and 396 children starting second-line. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

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Dtg accurip trial