
Publications

Pubblications
and downloadsODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing
Authors: Cecilia L. Moore, Anna Turkova , Hilda Mujuru , Adeodata Kekitiinwa, Abbas Lugemwa, Cissy M. Kityo, Linda N. Barlow-Mosha, et al et al. The ODYSSEY Trial Team
Published in: BMC Infectious Diseases.
EU grants Marketing Authorisation to first-ever dispersible-tablet dolutegravir
On 12 January 2021, the European Medicine Agency approved the use of dolutegravir 5mg dispersible tablets for treating HIV in young children living in Europe. This decision was based, in part, on data from our ODYSSEY trial, which we are conducting in close collaboration with the MRC CTU at the University College London.
The EMA also authorised updating dosing recommendations for dolutegravir film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.
This decision enables European children to now have access to age-appropriate formulations of HIV medicine and reduces the gap between the treatment options available for adults and children.
The Marketing Authorisation of dolutegravir dispersible tablets by the European Medicine Agency follows the US Food and Drug Administration (FDA) approval in June 2020.
Requests of regulatory approval are ongoing in other countries globally, to ensure that these new HIV treatments become available to children wherever they are needed.
Read the Press Release by ViiV Healthcare.
Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial
Authors: Bollen PDJ, Moore C, Mujuru H, et al. The ODYSSEY Trial Team
Published in: LANCET HIV. 2020;8:e533-e544
Adeqaute dolutegravir exposure dosed BID with rifampicin in children 6 to < 18 years
Authors: Waalewijn H, Mujuru HA, Amuge P, Cotton M, Bollen P, Chan M, Ali S, Variavan E, Makumbi S, Colbers A, Gibb D, Ford D, Burger D, Turkova A, and the ODYSSEY-trial team
Published in: Oral presentation at 27th Conference on Retroviruses and Opportunistic Infections, March 8th –11th, 2020 – Boston, MA
Adeqaute dolutegravir exposure dosed BID with rifampicin in children 6 to < 18 years
Authors: Waalewijn H, Mujuru HA, Amuge P, Cotton M, Bollen P, Chan M, Ali S, Variavan E, Makumbi S, Colbers A, Gibb D, Ford D, Burger D, Turkova A, and the ODYSSEY-trial team
Published in: 27th Conference on Retroviruses and Opportunistic Infections, March 8th –11th, 2020 – Boston, MA
ODYSSEY: design, current status, and baseline characteristics
Authors: Moore CL, Kekitinwa A, Kaudha E, et al; the ODYSSEY Trial Team
Published in: 10th International Workshop on HIV Pediatrics, Amsterdam, July 20-21st, 2018. Poster Number 34
Steady-state pharmacokinetics and early safety data in HIV-infected African children weighing 14 to <25kg on film-coated dolutegravir 25mg tablets
Authors: Bollen P, Turkova A, Hilda Mujuru H, et al. The ODYSSEY Trial Team
Published in: 10th International Workshop on HIV Pediatrics, Amsterdam, 20-21st July 2018. Poster Number 22
Adult dolutegravir 50mg film-coated tablets in children living with HIV weighing 20 to <25 kg
Authors: Bollen P, Turkova A, Mujuru H, et al. for the ODYSSEY Trial Team
Published in: 26th Conference on Retroviruses and Opportunistic Infections, March 4th – 7th, 2019– Seattle. P_830
Pharmacokinetics of dolutegravir 5mg dispersible tablets in children weighing 6 to <20kg dosed using WHO weight bands
Authors: Waalewijn H, Bollen PDJ, Moore C, Kekitiinwa A, et al. The ODYSSEY Trail Team
Published in: Oral Presentation at 10th IAS Conference, July, 21-24th 2019
Analysing small groups within clinical trials, while borrowing information from larger groups
Authors: Turner B, Ford D, Moore C, Gibb D, Turkova A, White I, and ODYSSEY trial team
Published in: Oral Presentation atInternational Society for Clinical Biostatics; July 16th 2019