ODYSSEY (PENTA 20)

Summary

A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity.

Timeline

Start

2016-09-20

Primary completion

2021-03-02

Completion

2023-12-07

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Dolutegravir (>=14kg Cohort) vs Standard of Care (>=14kg Cohort); p = 0.004; Risk Difference (RD) -0.08 (95% CI -0.14 to -0.03); Bootstrap method NCT02259127 ↗

paper CONCLUSIONS: In this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. PMID 34965338 ↗

Publications

• Results Turkova A, White E, Mujuru HA, Kekitiinwa AR, Kityo CM, Violari A, Lugemwa A, Cressey TR, Musoke P, Variava E, Cotton MF, Archary M, Puthanakit T, Behuhuma O, Kobbe R, Welch SB, Bwakura-Dangarembizi M, Amuge P, Kaudha E, Barlow-Mosha L, Makumbi S, Ramsagar N, Ngampiyaskul C, Musoro G, Atwine L, Liberty A, Musiime V, Bbuye D, Ahimbisibwe GM, Chalermpantmetagul S, Ali S, Sarfati T, Wynne B, Shakeshaft C, Colbers A, Klein N, Bernays S, Saidi Y, Coelho A, Grossele T, Compagnucci A, Giaquinto C, Rojo P, Ford D, Gibb DM; ODYSSEY Trial Team. Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children. N Engl J Med. 2021 Dec 30;385(27):2531-2543. doi: 10.1056/NEJMoa2108793.
• Results Amuge P, Lugemwa A, Wynne B, Mujuru HA, Violari A, Kityo CM, Archary M, Variava E, White E, Turner RM, Shakeshaft C, Ali S, Nathoo KJ, Atwine L, Liberty A, Bbuye D, Kaudha E, Mngqibisa R, Mosala M, Mumbiro V, Nanduudu A, Ankunda R, Maseko L, Kekitiinwa AR, Giaquinto C, Rojo P, Gibb DM, Turkova A, Ford D; ODYSSEY Trial Team. Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial. Lancet HIV. 2022 Sep;9(9):e638-e648. doi: 10.1016/S2352-3018(22)00163-1.
• Turkova A, White E, Violari A, Mujuru HA, Kekitiinwa AR, Lugemwa A, Kaudha E, Na-Rajsima S, Ahimbisibwe GM, Variavae E, Archary M, Akhalwaya Y, Puthanakit T, Bwakura-Dangarembizi M, Bbuye D, Kasozi M, Liberty A, Konigs C, Welch SB, Riault Y, Bamford A, Cressey TR, Musoke P, Kityo C, Ferrand R, Giaquinto C, Rojo P, Gibb DM, Ford D; ODYSSEY trial team. Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trial. Lancet Child Adolesc Health. 2026 Mar;10(3):189-202. doi: 10.1016/S2352-4642(25)00339-6. Epub 2026 Jan 21.
• White E, Kityo C, Spyer MJ, Mujuru HA, Nankya I, Kekitiinwa AR, Lugemwa A, Kaudha E, Liberty A, Cassim H, Archary M, Cotton MF, Ahimbisibwe GM, Cressey TR, Ngampiyaskul C, Srirompotong U, Behuhuma O, Saidi Y, Bamford A, Kobbe R, Nastouli E, Rojo P, Giaquinto C, Gibb DM, Ford D, Turkova A; ODYSSEY trial team. Virological outcomes and genotypic resistance on dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial. Lancet HIV. 2025 Mar;12(3):e201-e213. doi: 10.1016/S2352-3018(24)00155-3. Epub 2025 Feb 17.
• Barlow-Mosha LN, Ahimbisibwe GM, Chappell E, Amuge PM, Nanduudu A, Kaudha E, Amukele T, Balamusani D, Kafufu B, Nimwesiga A, Kataike H, Namwanje R, Kasangaki G, Mulindwa A, Muzorah GA, Bbuye D, Musiime V, Mujyambere E, Ssenyonga M, Mulima D, Kyambadde RC, Namusanje J, Isabirye R, Nabalamba M, Nakirya BM, Kityo C, Kekitiinwa AR, Giaquinto C, Copp A, Gibb DM, Ford D, Musoke P, Turkova A; ODYSSEY trial team. Effect of dolutegravir on folate, vitamin B12 and mean corpuscular volume levels among children and adolescents with HIV: a sub-study of the ODYSSEY randomized controlled trial. J Int AIDS Soc. 2023 Sep;26(9):e26174. doi: 10.1002/jia2.26174.
• Turkova A, Waalewijn H, Chan MK, Bollen PDJ, Bwakura-Dangarembizi MF, Kekitiinwa AR, Cotton MF, Lugemwa A, Variava E, Ahimbisibwe GM, Srirompotong U, Mumbiro V, Amuge P, Zuidewind P, Ali S, Kityo CM, Archary M, Ferrand RA, Violari A, Gibb DM, Burger DM, Ford D, Colbers A; ODYSSEY Trial Team. Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial. Lancet HIV. 2022 Sep;9(9):e627-e637. doi: 10.1016/S2352-3018(22)00160-6. Epub 2022 Jul 19.
• Singh RP, Adkison KK, Baker M, Parasrampuria R, Wolstenholme A, Davies M, Sewell N, Brothers C, Buchanan AM. Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children. Pediatr Infect Dis J. 2022 Mar 1;41(3):230-237. doi: 10.1097/INF.0000000000003366.
• Moore CL, Turkova A, Mujuru H, Kekitiinwa A, Lugemwa A, Kityo CM, Barlow-Mosha LN, Cressey TR, Violari A, Variava E, Cotton MF, Archary M, Compagnucci A, Puthanakit T, Behuhuma O, Saiotadi Y, Hakim J, Amuge P, Atwine L, Musiime V, Burger DM, Shakeshaft C, Giaquinto C, Rojo P, Gibb DM, Ford D; ODYSSEY Trial Team. ODYSSEY 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. BMC Infect Dis. 2021 Jan 4;21(1):5. doi: 10.1186/s12879-020-05672-6.
• Bollen PDJ, Moore CL, Mujuru HA, Makumbi S, Kekitiinwa AR, Kaudha E, Parker A, Musoro G, Nanduudu A, Lugemwa A, Amuge P, Hakim JG, Rojo P, Giaquinto C, Colbers A, Gibb DM, Ford D, Turkova A, Burger DM; ODYSSEY trial team. Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial. Lancet HIV. 2020 Aug;7(8):e533-e544. doi: 10.1016/S2352-3018(20)30189-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dolutegravir	Other / unclassified	—	—

Indications