Penta HIV Trials | PENTA 20 (ODYSSEY)

ODYSSEY 192-week follow-up evidences superior efficacy of DTG for children on first/second-line ART

2024

Authors: Mujuru AH, White E, Kekitiinwa A, Lugemwa A, Kityo C, Musoke P, Cressey RT, Variava E, Violari A, Archery M, Cotton M, Puthanakit T, Rojo P, Turkova A

Presented at: CROI 2024

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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 

2023

Authors: Barlow-Mosha L.N., Ahimbisibwe G.M., Chappell E., Amuge P.M., Nanduudu A., Kaudha E., Amukele T., Balamusani D., Kafufu B., Nimwesiga A., Kataike H., Namwanje R., Kasangaki G., Mulindwa A., Muzorah, G.A., Bbuye D., Musiime V., Mujyambere E., Ssenyonga M., Mulima D., Kyambadde R.C., Namusanje J., Isabirye R., Nabalamba M., Nakirya B.M., Kityo C., Kekitiinwa A.R., Giaquinto, C., Copp A., Gibb, D.M., Ford, D., Musoke P., Turkova A

Published in: Journal of the International AIDS Society

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

2022

Authors: Amuge P, Lugemwa A, Wynne B, Mujuru AH, Violari A, Kityo MC, Archary M, Variava E, White E, Turner MR, Shakeshaft C, Ali S, Nathoo JK, Atwine L, Liberty A, Bbuye D, Kaudha E, Mngqibisa R, Mosala M, Mumbiro V, Nanduudu A, Ankunda R, Maseko L, Kekitiinwa RA, Giaquinto C, Rojo P, Gibb MD, Turkova A, Ford D on behalf of the ODYSSEY Trial Team

Published in: The Lancet HIV

Voluntary Consent to Research on HIV-infected Children in the CHAPAS-4 and ODYSSEY HIV Clinical Trials

2022

Authors: Makumbi S, Bajunirwe F, Ford D, Turkova A, Lugemwa A, Musiime V, Gibb D, Tamwesigire K.I

Presented at: International Workshop on HIV & Pediatrics 2022

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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

2022

Authors: Turkova A, Waalewijn H, Chan M, Bollen P, Bwakura-Dangarembizi M, Kekitiinwa A, Cotton M, Lugemwa A, Variava E, Ahimbisibwe MG, Srirompotong U, Mumbiro V,Amuge P, Zuidewind P, Ali S, Kityo C,Archary M, Ferrand R, Violari A, Gibb D,Burger D, Ford D, Colbers A, on behalf of the ODYSSEY Trial Team

Published in: The Lancet

Borrowing information across patient subgroups in clinical trials, with application to a paediatric trial

2022

Authors: R.M. Turner, A Turkova, C.L. Moore, A Bamford, M Archary, L.N. Barlow-Mosha, M.F. Cotton, T.R. Cressey, E Kaudha, A Lugemwa, H Lyall, H.A. Mujuru, V Mulenga, V Musiime, P Rojo, G Tudor-Williams, S.B. Welch, D.M. Gibb, D Ford, I.R. White & and the ODYSSEY Trial Team

Published in: BMC Medical Research Methodology

Dolutegravir dosing for children with HIV weighing less than 20 kg: pharmacokinetic and safety substudies nested in the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

2022

Authors: H Waalewijn, M.K Chan, P.D.J Bollen, H.A Mujuru, S Makumbi, A.R Kekitiinwa, E Kaudha, T Sarfati, G Musoro, A Nanduudu, A Lugemwa, P Amuge, C.L Moore, P Rojo, C Giaquinto, A Colbers, D.M Gibb, D Ford, A Turkova, D.M Burger

Published in: The Lancet

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

2021

Authors: A Turkova, E White, HA. Mujuru, AR. Kekitiinwa, CM. Kityo, A Violari, A Lugemwa, TR. Cressey, P Musoke, E Variava, MF. Cotton, M Archary, et al for the ODYSSEY Trial Team

Published in: New England Journal of Medicine

Dolutegravir-based ART is superior to standard of care ART in young children <14kg living with HIV

2021

Authors: Kaudha E on behalf of the ODYSSEY trial

Presented at: PEPFAR Uganda Science Summit

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Dolutegravir-based ART is superior to NNRTI- and PI-based ART in infants, children and adolescents living with HIV (combined results of the main trial and the ‘under 14kg’ cohort)

2021

Authors: Anna Turkova on behalf of the ODYSSEY trial team

Presented at: CHIVA 2021

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Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the main ODYSSEY trial (≥14kg)

2021

Authors: White E and Kityo C on behalf of the ODYSSEY trial team

Presented at: CHIVA 2021

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No age-related difference in dolutegravir metabolic glucuronidation ratio in children between 3 months and 18 years old in the ODYSSEY trial

2021

Authors: T.G Jacobs, A. Colbers, H. Waalewijn, P. Amuge, D. Bbuye, E. Kaudha, A. Nanduudu, S. Makumbi, L. Atwine, S. Mudzingwa, K. Nathoo, J. Hakim, A. Liberty, A.J. Van Rensburg, M. Archary, D.M Gibb, D. Ford, A. Turkova, D.M Burger, ODYSSEY trial team

Published in: IAS 2021

 

Abstract

Background: ODYSSEY and IMPAACT-P1093 found lower and more variable dolutegravir (DTG) exposure in children compared to adults based on mg/kg dose.

Effect of dolutegravir on folate and vitamin B12 status among HIV- infected children and adolescents in the ODYSSEY trial

2021

Authors: L. Barlow-Mosha, G. Ahimbisibwe, E. Chappell, P.M. Amuge, A. Nanduudu, E. Kaudha, T. Amukele, D. Balamusani, B. Kafufu, A. Nimwesiga, C. Kityo, A.R Kekitiinwa, R. Namwanje, G. Kasangaki, A. Mulindwa, G.A. Muzorah, D. Bbuye, M. Nolan, C. Giaquinto, D.M Gibb, D. Ford, P. Musoke, A. Turkova, The ODYSSEY Trial Team

Presented at: International workshop on HIV pediatrics 2021

Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

2021

Authors: E White, A Turkova, HA Mujuru, I Nankya, B Wynne, S Ali, A Kekitiinwa, A Lugemwa, E Kaudha, A Liberty, H Cassim, M Archary, M Cotton, L Barlow-Mosha, TR Cressey, C Ngampiyasakul, U Srirompotong, O Behuhuma, Y Saidi, A Bamford, R Kobbe, P Rojo, C Giaquinto, DM Gibb, D Ford on behalf of the ODYSSEY trial team

Published in: International Workshop on HIV pediatrics

 

Dolutegravir-based ART is superior to NNRTI- and PI-based ART in infants, children and adolescents living with HIV (combined results of the main trial and the ‘under 14kg’ cohort)

2021

Authors: Turkova A on behalf of the ODYSSEY trial team     

Presented at: CHIVA 2021

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Neuropsychiatric manifestations and sleep disturbances in children and adolescents randomised to dolutegravir-based ART vs standard-of-care in the ODYSSEY trial

2021

Authors: A Turkova, A Kekitiinwa, E White, V Mumbiro, E Khauda, A Liberty, E Dobbels, GM Ahimbisibwe, T Moloantoa, L Atwine, S Kanjanavanit, NR Mosia, T Puthanakit, T Smit, R Kobbe, C Fortuny, E Chidziva, RC Kyambadde, D Bbuye, T Sarfati, A Coelho, Y Saïdi, A Lugemwa, N Klein, M Bwakura-Dangarembizi, C Kityo, M Cotton, C Giaquinto, P Rojo, DM Gibb, D Ford, the ODYSSEY trial team

Published in: IAS 2021

 

Neuropsychiatric manifestations and sleep disturbances in children and adolescents randomised to dolutegravir-based ART vs standard-of-care in the ODYSSEY trial

2021

Authors: Violari A, Kekitiinwa A, White E, Mumbiro V, Rutebarika D, Dobbels E, Kataike H, Moloantoa T, Atwine L, Nazzinda R, Mbabazi R, Kanjanavanit S, Mosia N, Na-Rajsimax S, Techakunakorn P, Nakabuye S, Puthanakit T, Smit T, Kobbe R, Fortuny C, Chidziva E, Nansamba W, Kakayi B, Bbuye D, Sarfati T, Shakeshaft C, Coelho A, Saïdi Y, Lugemwa A, Klein N, Mujuru H, Bwakura- Dangarembizi M, Musiime V,

Effect of dolutegravir on folate and vitamin B12 status among HIV- infected children and adolescents in the ODYSSEY trial

2021

Authors: L. Barlow-Mosha, G. Ahimbisibwe, E. Chappell, P.M. Amuge, A. Nanduudu, E. Kaudha, T. Amukele, D. Balamusani, B. Kafufu, A. Nimwesiga, C. Kityo, A.R Kekitiinwa, R. Namwanje, G. Kasangaki, A. Mulindwa, G.A. Muzorah, D. Bbuye, M. Nolan, C. Giaquinto, D.M Gibb, D. Ford, P. Musoke, A. Turkova, The ODYSSEY Trial Team

Published in: IAS 2021

 

Abstract

Background: Neural tube defects (NTDs) are known to be associated with maternal folate and vitamin B12 deficiency,

Dolutegravir-Based ART is Superior to Standard of Care in Young Children Living With HIV

2021

Authors: P Amuge on behalf of the ODYSSEY trial team

Published in: International workshop on HIV pediatrics 2021

 

Abstract

Background: ODYSSEY, a multi-country randomised trial, demonstrated superior treatment efficacy for dolutegravir (DTG) plus two NRTIs versus standard-ofcare (SOC) in 707 children ≥14kg (median age 12 years) starting first- or second-line ART.

Weight Gain in Children and Adolescents on Dolutegravir vs Standard-of-Care in the ODYSSEY Trial

2021

Authors: Mujuru H , Lugemwa A, Puthanakit T, Amuge P, Kityo C, Compagnucci A, Variava E, Kekitiinwa A, Musiime V, BarlowMosha L, Ngampiyaskul C, Zuidewind P, Tumusiime J, Mngqbisa R, Kaudha E, Behuhuma N, Kataike H, Musoro G, Nandudu A, Bwakura M, Ahimbisibwe G, Ounchanum P, Mulindwa A, Nazzinda R, Ssenyonga M, Kanjanavanit S, Nathoo K, Makumbi S, Danaviah S, Nakabuye S, Chalermpantmetagul S, Rutebarika D, Nalusiba S,

A randomised comparison of DTG-based ART vs Standard of Care in infants and young children living with HIV weighing 3 to 14kg: results from the ODYSSEY trial

2021

Authors: A Lugemwa, H Mujuru, B Wynne, A Violari, AR Kekitiinwa, CM Kity, M Archary, E Variava, T Sarfati, C Shakeshaft, R Turner, K Nathoo, E Chidziva, L Atwine, N Ramsagar, A Liberty, P Amuge, E Kaudha, A Nanduudu, R Mngqibisa, R Mosia, MF Cotton, TR Cressey, T Puthanakit, A Compagnucci, C Giaquinto, P Rojo, D Ford, DM Gibb, A Turkova, the ODYSSEY trial team

Published in: IAS 2021

 

Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

2021

Authors: C. Kityo, E. White, A. Turkova, H.A Mujuru, I. Nankya, B. Wynne, S. Ali, A. Kekitiinwa, A. Lugemwa, E. Kaudha, A. Liberty, H. Cassim, M. Archary, M. Cotton, L. Barlow-Mosha, T.R Cressey, C. Ngampiyasakul, U. Srirompotong, O. Behuhuma, Y. Saidi, A. Bamford, R. Kobbe, P. Rojo, C. Giaquinto, D. Gibb, D. Ford

Published in: IAS 2021

 

Abstract

Background: ODYSSEY demonstrated superiority of dolutegravir (DTG) based ART versus standard-of-care (SOC) in children ≥14kg starting first- or second-line.

A randomised comparison of DTG-based ART vs Standard of Care in infants and young children living with HIV weighing 3 to 14kg: results from the ODYSSEY trial

2021

Authors: LugemwaA, Mujuru H, Wynne B, Violari A, Kekitiinwa R.A, Kityo M.C, Archary M, Variava E, Sarfati T, Shakeshaft C, Turner  R, Nathoo R, Chidziva E, Atwine L, Ramsagar N, Liberty A, Amuge P, Kaudha E, Nanduudu A, Mngqibisa R, Mosia R, Cotton F.M, Cressey R.T, Puthanakit T, Compagnucci A, Giaquinto C, Rojo P, Ford D, Gibb M.D, Turkova A, the ODYSSEY trial team

Presented at: IAS 2021

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Neuropsychiatric manifestations and sleep disturbances in children and adolescents randomised to dolutegravir-based ART vs standard-of-care in the ODYSSEY trial

2021

Authors: Turkova A, Kekitiinwa A, White E, Mumbiro V, Khauda E, Liberty A, Dobbels E, Ahimbisibwe M.G, Moloantoa T, Atwine T, Kanjanavanit S, Mosia R.N, Puthanakit T, Smit T, Kobbe R, Fortuny C, Chidziva E, Kyambadde C.R,  Bbuye d, Sarfati T, Coelho A, Saïdi Y, Lugemwa A, Klein N, Bwakura- Dangarembizi M, Kityo C, Cotton M, Giaquinto C, Rojo P, Gibb M.D, Ford D, the ODYSSEY trial team

Presented at: IAS 2021

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Weight gain in children and adolescents on dolutegravir vs standard of care in the ODYSSEY trial

2021

Authors: Turkova A, Kityo C, Mujuru A.H, Variava E, Kekitiinwa A, Lugemwa A, Barlow-Mosha L, Ngampiyaskul C, Zuidewind P, Puthanakit T, Mngqbisa R, Behuhuma O.N, Kataike H, Musoro G, Nandudu A, Amuge P, Makumbi S, Danaviah S, Ali S, Wynne B, Riault Y, Welch S, Cressey R.T, Violari A, Compagnucci A, Hakim J, Rojo P, Giaquinto C,  Gibb M.D, Ford D, the ODYSSEY trial team

Presented at : IAS 2021

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Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

2021

Authors: Kityo C, White E, Turkova A, Mujuru A.H, Nankya I, Wynne B, Ali S, Kekitiinwa A, Lugemwa A, Kaudha E, Liberty A, Cassim H, Archary M, Cotton M, Barlow-Mosha L, Cressey R.T, Ngampiyasakul C, Srirompotong U, Behuhuma O, Saidi Y, Bamford A, Kobbe R, Rojo P, Giaquinto C, Gibb M.D, Ford D on behalf of the ODYSSEY trial team

Presented at: IAS 2021

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Because we all have to grow up”: supporting adolescents in Uganda to develop core competencies to transition towards managing their HIV more independently

2021

Authors: Chloe Lanyon, Janet Seeley, Stella Namukwaya, Victor Musiime, Sara Paparini, Helen Nakyambadde, Christine Matama, Anna Turkova, Sarah Bernays

 

Published in: Journal of International Aids Society

 

Abstract

Introduction: Sustaining optimal adherence is the major challenge facing adolescents living with HIV (ALHIV), particularly in low-resource settings, where “second-line” is often the last accessible treatment option.

DOLUTEGRAVIR-BASED ART IS SUPERIOR TO NNRTI/PI- BASED ART IN CHILDREN AND ADOLESCENTS

2021

Authors: Anna Turkova1, for the ODYSSEY/PENTA-20 Trial Team

Published in: CROI 2021

 

Abstract: ODYSSEY is an international multi-centre randomised non-inferiority trial evaluating dolutegravir (DTG) + 2NRTIs versus standard-of-care (SOC) in children starting rst- or second-line ART.

Methods: The primary outcome is a Kaplan-Meier estimated proportion of treatment failure dened as conrmed viral load (VL) ≥400c/mL after week 36,

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

2021

Authors: Cecilia L. Moore, Anna Turkova , Hilda Mujuru , Adeodata Kekitiinwa, Abbas Lugemwa, Cissy M. Kityo, Linda N. Barlow-Mosha, et al, ODYSSEY trial team

Published in: BMC Infectious Diseases

 

Background: Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in children and adolescents.

Pediatric dolutegravir (DTG) dosing recommendations derived from combined P1093 and ODYSSEY Population Pharmacokinetic analysis

2020

Authors: Singh R, Baker M, Thapar M, Gibb D, Turkova A, Ford D, Ruel T, Wiznia A, Farhad M, Alvero C, Green J, Bollen P, Colbers A, Burger D, Acosta E

Published in: 12th International Workshop on HIV Pediatrics

View Abstract booklet

 

Background: HIV treatment options remain limited in children. The recent Tivicay (dolutegravir,

Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

2020

Authors: Bollen P,  Moore CL ,  Mujuru H et al; the ODYSSEY trial team

Published in: LANCET HIV. 2020;8:e533-e544

Background Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest.

Adeqaute dolutegravir exposure dosed BID with rifampicin in children 6 to < 18 years

2020

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 in27th Conference on Retroviruses and Opportunistic Infections, March 8th –11th, 2020 – Boston.

Adeqaute dolutegravir exposure dosed BID with rifampicin in children 6 to < 18 years

2020

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.

Analysing small groups within clinical trials, while borrowing information from larger groups

2019

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

Pharmacokinetics of dolutegravir 5mg dispersible tablets in children weighing 6 to <20kg dosed using WHO weight bands

2019

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

Adult dolutegravir 50mg film-coated tablets in children living with HIV weighing 20 to <25 kg

2019

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

Steady-state pharmacokinetics and early safety data in HIV-infected African children weighing 14 to <25kg on film-coated dolutegravir 25mg tablets

2018

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

ODYSSEY: design, current status, and baseline characteristics

2018

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

“I failed to take them as I should and now I’m scared”: how can we support adolescents’ adherence on second line HIV treatment

2018

Authors: Bernays S, Namukwaya S, Mupambireyi Z, Nanduudu A, Mujuru H, Turkova A, Gibb DM, Seeley J, and the ODYSSEY Trial Team.

Published in: 10th International Workshop on HIV Pediatrics, Amsterdam, July 20-21st 2018. Poster number 117

Steady-state pharmacokinetics and early safety data in HIV-infected African children weighing ≥25kg after switching to 50mg film-coated dolutegravir tablets in the ODYSSEY trial

2018

Authors: Turkova A, Bollen P, Kaudha E, et al. The ODYSSEY Trial Team

Published in: Oral Presentation at 10th International Workshop on HIV Pediatrics, Amsterdam, July 20-21st, 2018

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