HIV | Penta HIV Trials

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

Population pharmacokinetics of unbound and total plasma dolutegravir concentrations in children ≥ 12 years old: A pharmacokinetic sub-study of the SMILE trial-PENTA17-ANRS 152

2022

Authors: Abdalla S, Compagnucci A, Riault Y, Cressey T, Saidi Y, Chan M, Coelho A, Nolan A, Chalermpantmetagul S, Amuge P, Musiime V, Violari A, Cotton M, Volokha A, Bologna R, Pavia Ruz N, Morkunaite G, Giaquinto C, Tréluyer JM, Zheng Y, Bamford A, Ramos Amador J, Hirt D

Presented at: International Workshop on HIV and Pediatrics

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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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Once daily integrase inhibitor (INSTI) with boosted darunavir is non-inferior to standard of care in virologically suppressed children – Week 48 results of the SMILE Penta-17 Trial

2021

Authors: Compagnucci A, Chan M, Saïdi Y, Cressey T, Bamford A, Riault Y, Coelho A, Nolan A, Chalermpantmetagul S, Amuge P, Musiime V, Violari A, Cotton M, Kekitiinwa A, Kaudha E,Groenewald M, Liberty A, Kanjanavanit S, Volokha A, Bologna R, Pavia Ruz N, Prieto Tato L, Paioni P, Marques L, Reliquet V, Welch S, Ford D, Giaquinto C, Gibb D, Babiker A, Ramos Amador JT,

Once-Daily Integrase Inhibitor (Insti) With Boosted Darunavir is Non- Inferior to Standard of Care in Virogically Suppressed Children, Week 48 Results of the SMILE PENTA-17 Trial

2021

Authors: Compagnucci A , Chan M , Saïdi Y , Cressey T , Bamford A , Riault Y , Coelho A , Nolan A ,Chalermpantmetagul S , Amuge P , Musiime V , Violari A , Cotton M , Kekitiinwa A , Kaudha E , Groenewald M, Liberty A , Kanjanavanit S , Volokha A , Bologna R , Muñoz Hernández R , Fortuny-Guasch C , Paioni P ,

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

Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries

2018

Authors: Tierrablanca LE, Ochalek J, Ford D, et al; for BREATHER (PENTA 16) Trial Group

Published in: Medicine (Baltimore). 2018;97(5):e9698

Objectives To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs.

Weekends-off efavirenz -based antiretroviral therapy in HIV infected children, adolescents and young adults (BREATHER): extended follow-up results of a randomised, open-label, non-inferiority trial

2018

Authors: Turkova A, Moore CL, Butler K, et al. for BREATHER (PENTA 16) Trial Group.

Published in: PLos One. 2018;13(4):e0196239.

Background Weekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks.

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

Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

2017

Authors: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T.

Published inBMJ Open. 2017;7(2):e012934

Objectives A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8–24) living with HIV with viral load <50 c/mL to examine adaptation,

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

2017

Authors: Namukwaya S, Paparini S, Seeley J, Bernays S.

Published in: Front Public Health. 2017;5:343.

Abstract: Despite great advances in pediatric HIV care, rates and the extent of full disclosure of HIV status to infected children remain low especially in resource-constrained setting. The World Health Organisation recommends that, by the age of 10-12 years old,

“Not Taking it Will Just be Like a Sin”: Young People Living with HIV and the Stigmatization of Less-Than-Perfect Adherence to Antiretroviral Therapy

2017

Authors: Bernays S, Paparini S, Seeley J, Rhodes T.

Published in: Med Anthropol. 2017;36(5):485-499.

Abstract: Global health priorities are being set to address questions on adherence to HIV antiretroviral therapy in adolescence. Few studies have explored young people’s perspectives on the complex host of social and relational challenges they face in dealing with their treatment in secret and their condition in silence.

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial

2016

Author: Butler K, Inshaw J, Ford D, et al.

Published in:  Health Technol Assess. 2016;20(49):1-108.

Background For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.

Objectives To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy;

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial

2016

Author: The BREATHER (PENTA 16) Trial Group

Published inLancet HIV. 2016;3(9):e421-430

Background For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).

Neurocognition and quality of life after reinitiating antiretroviral therapy in children randomized to planned treatment interruption

2016

Authors: Ananworanich J, Melvin D, Ramos Amador JT, et al; on behalf of the PENTA 11 study group.

Published in: AIDS. 2016;30(7):1075-81.

Objective Understanding the effects of antiretroviral treatment (ART) interruption on neurocognition and quality of life (QoL) are important for managing unplanned interruptions and planned interruptions in HIV cure research.

Design Children previously randomized to continuous (continuous ART, 

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