Action 5. Focus research efforts on optimal drugs and formulations as defined by PADO.

Action 19. Undertake studies that use weight-based dosing, enroll all paediatric weight-band groups concurrently irrespective of age, and maximize opportunities to accelerate enrollment of subjects.

Action 5

PENTA and IMPAACT research networks have disseminated the Rome Action Plan to their members which is being considered for planning of future research projects.

Action 19

IMPAACT and PENTA are continuing collaborative work on the P1093 and ODYSSEY studies to expedite the determination of appropriate dosing for DTG in children below 30 kg. Both studies are investigating WHO weight bands- based dosing.

34. Rapidly develop and implement research actions (including carrying out specific studies to generate high quality evidence for regulatory submissions and high quality pharmacovigilance studies where needed) in the framework of GAP-f to accelerate access to innovative, high quality, and affordable drugs for children worldwide.

35. Ensure appropriate evidence generation from ongoing DTG studies to enable ViiV regulatory submissions by end 2019.

Action 34

PENTA has been working very closely with CHAI, WHO, EGPAF and other within the GAPf framework. Plans for studies are ongoing on TAF/xTC/DTG  and DRV/r FDC.

Action 35

DTG safety and dosing trials; moving ahead well. Also moving ahead on a study for DTG in 0 to 4 weeks.

PENTA and IMPAACT completed a new modeling work which will inform the dosing estimates for the neonatal DTG protocol which is moving quickly in development.

June 2020

IMPAACT is developing study to determine dosing for DTG in neonates 0 to 4 weeks old; study launch awaits manufacture of new elixir formulation, anticipated in 4th quarter or 2020.