ODYSSEY: Once daily Dolutegravir in Young people vS Standard thErapY

Conditions

HIV infection Infections and Infestations Human immunodeficiency virus [HIV] disease

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, Königs 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.

2026-01-21

10.1016/s2352-4642(25)00339-6

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.

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.

2025-02-177 citations

10.1016/s2352-3018(24)00155-3

Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda

Shafic Makumbi, Francis Bajunirwe, Deborah Ford, Anna Turkova, Annabelle South et al. (9 authors)

BMJ Open2024-03-01

10.1136/bmjopen-2023-077546

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.

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.

2022-07-1920 citations

10.1016/s2352-3018(22)00160-6

Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children

Anna Turkova, Ellen White, Hilda A. Mujuru, Adeodata R. Kekitiinwa, Cissy M. Kityo et al. (45 authors)

New England Journal of Medicine2021-12-29105 citations

10.1056/nejmoa2108793

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.

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, Saϊdi Y, Hakim J, Amuge P, Atwine L, Musiime V, Burger DM, Shakeshaft C, Giaquinto C, Rojo P, Gibb DM, Ford D, ODYSSEY Trial Team.

2021-01-0432 citations

10.1186/s12879-020-05672-6

Interventions

Dolutegravir plus two NRTIs (dolutegravir arm) vs standard of care (SOC arm) in first-line and second-line antiretroviral regimens

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Children 1000 copies/ml at screening visit

Exclusion criteria

Exclusion criteria: 1. Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN) 2. History or presence of allergy to the study drugs or their components

Design outcomes

Primary

Measure	Time frame
Difference in proportion with clinical or virological failure at 96 weeks, estimated using time to the first occurrence of any of the following components: 1. Insufficient virological response defined as 400 copies/ml at or after 36 weeks confirmed by next visit 3. Death due to any cause 4. Any new or recurrent AIDS-defining event (CDC C or WHO 4) or severe/modified CDC B/WHO 3 events, adjudicated by the Endpoint Review Committee (ERC)	—

Measure

Time frame

Difference in proportion with clinical or virological failure at 96 weeks, estimated using time to the first occurrence of any of the following components: 1. Insufficient virological response defined as 400 copies/ml at or after 36 weeks confirmed by next visit 3. Death due to any cause 4. Any new or recurrent AIDS-defining event (CDC C or WHO 4) or severe/modified CDC B/WHO 3 events, adjudicated by the Endpoint Review Committee (ERC)

—

Secondary

Measure	Time frame
Secondary efficacy outcomes: 1. Difference in proportion with clinical or virological failure over 48 weeks 2. Time to any new or recurrent AIDS-defining event (CDC C or WHO 4) or severe/modified CDC B/WHO 3 events after 24 weeks from randomisation, adjudicated by the Endpoint Review Committee (ERC) 3. Proportion of children with VL suppression 400 c/ml Secondary safety outcomes: 1. Change in total cholesterol, triglycerides and lipid fractions (LDL, HDL) from baseline to weeks 48 and 96 These safety outcomes will be used to formally assess superiority of dolutegravir-based regimen vs standard of care 2. Incidence of serious adverse events 3. Incidence of new clinical and laboratory grade 3 and 4 adverse events 4. Incidence of adverse events (of any grade) leading to treatment modification	—

Measure

Time frame

Secondary efficacy outcomes: 1. Difference in proportion with clinical or virological failure over 48 weeks 2. Time to any new or recurrent AIDS-defining event (CDC C or WHO 4) or severe/modified CDC B/WHO 3 events after 24 weeks from randomisation, adjudicated by the Endpoint Review Committee (ERC) 3. Proportion of children with VL suppression 400 c/ml Secondary safety outcomes: 1. Change in total cholesterol, triglycerides and lipid fractions (LDL, HDL) from baseline to weeks 48 and 96 These safety outcomes will be used to formally assess superiority of dolutegravir-based regimen vs standard of care 2. Incidence of serious adverse events 3. Incidence of new clinical and laboratory grade 3 and 4 adverse events 4. Incidence of adverse events (of any grade) leading to treatment modification

—

Countries

Albania, Spain

Outcome results

None listed