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
In: ISSN: 2352-3018 ; The Lancet HIV ; https://hal.science/hal-04543930 ; The Lancet HIV, 2022, 2022
academicJournal
Zugriff:
International audience ; Background: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB.Methods: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to <18 years) with HIV-associated TB who were receiving rifampicin and twice-daily dolutegravir were eligible for inclusion. We did a 12-h pharmacokinetic profile on rifampicin and twice-daily dolutegravir and a 24-h profile on once-daily dolutegravir. Geometric mean ratios for trough plasma concentration (Ctrough), area under the plasma concentration time curve from 0 h to 24 h after dosing (AUC0-24 h), and maximum plasma concentration (Cmax) were used to compare dolutegravir concentrations between substudy days. We assessed rifampicin Cmax on the first substudy day. All children within ODYSSEY with HIV-associated TB who received rifampicin and twice-daily dolutegravir were included in the safety analysis. We described adverse events reported from starting twice-daily dolutegravir to 30 days after returning to once-daily dolutegravir. This trial is registered with ClinicalTrials.gov (NCT02259127), EudraCT (2014-002632-14), and the ISRCTN registry (ISRCTN91737921).Findings: Between Sept 20, 2016, and June 28, 2021, 37 children with HIV-associated TB (median age 11·9 years [range 0·4-17·6], 19 [51%] were female and 18 [49%] were male, 36 [97%] in Africa and one [3%] in Thailand) received rifampicin with twice-daily dolutegravir and were included in the safety analysis. 20 (54%) of 37 children enrolled in the pharmacokinetic substudy, 14 of whom contributed at least one evaluable pharmacokinetic curve for dolutegravir, including 12 who had within-participant comparisons. Geometric mean ratios for ...
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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
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| Autor/in / Beteiligte Person: | Turkova, Anna ; Waalewijn, Hylke ; Chan, Man ; Bollen, Pauline ; Bwakura-Dangarembizi, Mutsa ; Kekitiinwa, Adeodata ; Cotton, Mark ; Lugemwa, Abbas ; Variava, Ebrahim ; Ahimbisibwe, Grace Miriam ; Srirompotong, Ussanee ; Mumbiro, Vivian ; Amuge, Pauline ; Zuidewind, Peter ; Ali, Shabinah ; Kityo, Cissy ; Archary, Moherndran ; Ferrand, Rashida ; Violari, Avy ; Gibb, Diana ; Burger, David ; Ford, Deborah ; Colbers, Angela ; Abraham, Pattamukkil ; Abrams, Elaine ; Acero, Judith ; Agaba, Gerald Muzorah ; Ahimbisibwe, Grace ; Ainebyoona, Barbara ; Akobye, Winnie ; Akhalwaya, Yasmeen ; Akoojee, Nazim ; Andrea, Catherine ; Muñoz Fernandez, Maria Angeles ; Ankunda, Rogers ; Rutebarika, Diana Antonia ; Anugulruengkitt, Suvaporn ; Apollo, Tsitsi ; Arendze, Ronelle ; Ategeka, Juliet ; Atim, Eunice ; Atwine, Lorna ; Babiker, Abdel ; Babirye, Sarah ; Babu, Enock ; Bagirigomwa, Edward ; Baita, Angella ; Balamusani, David ; Baliram, Patsy ; Baliruno, David ; Ball, Colin ; Balwa, Henry ; Bamford, Alasdair ; Bandi, Srini ; Barker, Dominique ; Barlow-Mosha, Linda ; Bbuye, Dickson ; Begum, Shazia ; Behuhuma, Osee ; Bernays, Sarah ; Besigye, Rogers ; Bester, Maria ; Bhiri, Joyline ; Bilardi, Davide ; Bird, Kristien ; Borg, Chiara ; Borges da Silva, Anne-Marie ; Brown, Jackie ; Bruno, Elena ; Bunupuradah, Torsak ; Buthelezi, Nomzamo ; Byaruhanga, Africanus ; Calvert, Joanna ; Casey, Petronelle ; Cassim, Haseena ; Cebekhulu, Sphiwee ; Chailert, Sanuphong ; Chalermpantmetagul, Suwalai ; Chamjamrat, Wanna ; Chandiwana, Precious ; Chankun, Thannapat ; Chanthaburanun, Sararut ; Chanto, Nuttawut ; Chidziva, Ennie ; Chikowore, Minenhle ; Chimanzi, Joy ; Chinwong, Dujrudee ; Chitongo, Stuart ; Chitsamatanga, Moses ; Choga, Joshua ; Chutima, Duangrat ; Clayden, Polly ; Coelho, Alexandra ; Compagnucci, Alexandra ; Constança Mendes, Ana ; Conway, Magda ; Crawley, Jane ; Cressey, Tim ; Crisp, Jacky ; Matos, Ana Cristina ; Dadan, Sumaya ; Daglish, Jacqui ; Danaviah, Siva ; Daniel, Tseleng ; de Rossi, Anita ; Denjanta, Sukanda ; Dobbels, Els ; Dowie, Maria ; Dube, Prosper ; Dube, Benedictor ; Dudakia, Nimisha ; Elwana, Alice ; Epalza, Cristina ; Eram, David ; Erasmus, Juan ; Erim, Peter ; Escosa Garcia, Luis ; Essack, Zaakirah ; Estepa, Carolina ; Etima, Monica ; Fernandes, Alexandre ; Fernandez, Maite ; Fitzgerald, Felicity ; Flynn, Jacquie ; Fortuny Guasch, Claudia ; Foster, Caroline ; Fourie, George ; Fourie, Yolandie ; Foxall, Sophie ; Frank, Derusha ; Gandhi, Kate ; Garcia, India ; Gartner, Kathleen ; Gasa, Joshua ; Gasa, Gugu ; Giaquinto, Carlo ; Gomez Rico, Coral ; Gomez-Pena, Daniel ; Gondo, Secrecy ; Goodman, Anna ; Gorreti Nakalema, Maria ; Gozhora, Winnie ; Greetanukroh, Pisut ; Gregorio Maranon, Biobanco ; Grossele, Tiziana ; Gwande, Shamiso ; Gwaze, Tapiwa ; Gwenzi, Tsitsi ; Hakim, James ; Hakiza, Emmanuel ; Kaka, Abdul Hamid ; Harley, Ashley ; Isaacs, Mornay ; Isabirye, Richard ; Ishemunyoro, Wilber ; Jacobs, Tom ; Jafta, Lungile ; Jamil, Nasir ; Janse van Rensburg, Anita Janse ; Jeaven, Vinesh ; Mellado Peña, Maria José ; Jourdain, Gonzague ; Juliet, Katabalwa ; Jumpimai, Thidarat ; Junkaew, Raungwit ; Jupimai, Thidarat ; Kaahwa, Winfred ; Kabasonga, Mildred ; Kaboggoza, Olivia ; Kadhuba, Rose Jacqueline ; Kaewbundit, Ampika ; Kaewmamueng, Kanyanee ; Kafufu, Bosco ; Kakayi, Brenda ; Kamboua, Phakamas ; Kanjanavanit, Suparat ; Kasangaki, Gladys ; Kasipong, Naruporn ; Kasozi, Miriam ; Kataike, Hajira ; Katemba, Chrispus ; Kaudha, Elizabeth ; Kekane, Nkata ; Keminyeto, Edridah ; Khamduang, Woottichai ; Khamjakkaew, Warunee ; Khamkon, Jiraporn ; Khannak, Sasipass ; Khatngam, Orapin ; Khayanchoomnoom, Tassawan ; Khumalo, Busi ; Khunene, Mirriam ; Khusuwan, Suwimon ; Kibalama, Phionah ; Kibenge, Robinah ; Kirabira, Anthony ; Kiyimba, Lameck ; Klein, Nigel ; Klinprung, Soraya ; Kobbe, Robin ; Kobusingye, Olivia ; Kobusungye, Josephine ; Kongponoi, Areerat ; Königs, Christoph ; Koole, Olivier ; Kouakam, Christelle ; Krueduangkam, Nitinart ; Kruenual, Namthip ; Kunjaroenrut, Nuananong ; Kyambadde, Raymonds ; Kyobutungi, Priscilla ; Kyomuhendo, Flavia ; Kyomukama, Erinah ; Lakha, Reshma ; Langa, Cleopatra ; Laomanit, Laddawan ; Lebotsa, Emily ; Leenasirimakul, Prattana ; Lekku, Lawrence ; Lensen, Sarah ; Leroy, Valériane ; Li, Jin ; Liberty, Afaaf ; Limplertjareanwanich, Juthamas ; Little, Emma ; Lutalo, Ezra ; Jimenez, Jose Luis ; Lyall, Hermione ; Macdonald, Candice ; Machache, Gladness ; Madlala, Penelope ; Madonsela, Tryphina ; Maduna, Nomfundo ; Maena, Joel ; Mahanontharit, Apicha ; Makanga, Collin ; Makola, Candice ; Makumbi, Shafic ; Malgraaf, Lucille ; Mamiane, Angelous ; Mantkowski, Felicia ; Mapfumo, Wendy ; Marques, Laura ; Mugagga, Agnes Mary ; Maseko, Lindiwe ; Masienyane, Tshepiso ; Mathiba, Ruth ; Matimba, Farai ; Mawlana, Sajeeda ; Mayanja, Emmanuel ; Mayat, Fatima ; Mbabazi, Ritah ; Mbadaliga, Nokuthula ; Mbasani, Faith ; Mcclaughlin, Kathleen ; Mcilleron, Helen ; Meethaisong, Watchara ; Mendez Garcia, Patricia ; Miwanda, Annet ; Miranda, Carlota ; Mkhize, Siphiwe ; Mmolawa, Kgosimang ; Mngqibisa, Rosie ; Mohamed, Fatima ; Moloantoa, Tumelo ; Monametsi, Maletsatsi ; Montero, Samuel ; Moore, Cecilia ; Mosia, Rejoice ; Moyo, Columbus ; Mthethwa, Mumsy ; Mudzingwa, Shepherd ; Mudzviti, Tawona ; Mujuru, Hilda ; Mujyambere, Emmanuel ; Mukanganiki, Trust ; Mukisa Williams, Cynthia ; Mulder, Mark ; Mulima, Disan ; Mulindwa, Alice ; Mupambireyi, Zivai ; Murciano Cabeza, Alba ; Murungi, Herbert ; Murungu, Dorothy ; Musarurwa, Sandra ; Musiime, Victor ; Musiime, Alex ; Musisi, Maria ; Musoke, Philippa ; Musoke Nakirya, Barbara ; Musoro, Godfrey ; Musumba, Sharif ; Mustafa, Sobia ; Mutsai, Shirley ; Mwesigwa Rubondo, Phyllis ; Naabalamba, Mariam ; Nagawa, Immaculate ; Naidoo, Allemah ; Nakabuye, Shamim ; Nakabuye, Sarah ; Nakalanzi, Sarah ; Nalubwama, Justine ; Nalugo, Annet ; Nalusiba, Stella ; Namajja, Clementine ; Namanda, Sylvia ; Namayanja, Paula ; Nambi, Esther ; Namuddu, Rachael Kikabi ; Namukwaya, Stella ; Namuli, Florence ; Namusanje, Josephine ; Namwanje, Rosemary ; Nanan-Kanjee, Anusha ; Nanduudu, Annet ; Nankunda, Charity ; Baddokwaya, Joanita Nankya ; Nannungi, Maria ; Nansamba, Winnie ; Nanthapisal, Kesdao ; Nanyonjo, Juliet ; Na-Rajsima, Sathaporn ; Nasaazi, Claire ; Nascimento, Helena ; Nastouli, Eleni ; Songtaweesin, Wipaporn Natalie ; Nathoo, Kusum ; Natuhurira, Ian ; Nazzinda, Rashidah ; Ncgaba, Thabisa ; Ndigendawani, Milly ; Ndlovu, Makhosonke ; Nentsa, Georgina ; Ngampiyaskul, Chaiwat ; Ngcobo, Ntombenhle ; Ngo Giang Huong, Nicole ; Ngwaru, Pia ; Nhema, Ruth ; Ninsiima, Emily ; Ninsiima, Gloria ; Nkalo Phiri, Misheck ; Noguera Julian, Antoni ; Nolan, Monica ; Noppakaorattanamanee, Thornthun ; Nsibuka Kisekka, Muzamil ; Nsirim, Eniola ; Nundlal, Rashina ; Nunes, Rosita ; Nyantsa, Lungile ; Nyati, Mandisa ; O'Riordan, Sean ; Ocitti Labeja, Paul ; Odoch, Denis ; Oguntimehin, Rachel ; Ojok, Martin ; Onen, Geoffrey ; Orange, Wilma ; Ounchanum, Pradthana ; Ouma, Benson ; Padrao, Andreia ; Pako, Deborah ; Parker, Anna ; Pasko-Szcech, Malgorzata ; Patel, Reena ; Peongjakta, Rukchanok ; Petpranee, Turian ; Phillips, Tasmin ; Philps, Jackie ; Picault, Laura ; Pieterse, Sonja ; Pinheiro, Helena ; Pongprapass, Supawadee ; Pozniak, Anton ; Prendergast, Andrew ; Prieto Tato, Luis ; Puangmalai, Patcharee ; Puthanakit, Thanyawee ; Rakgokong, Modiehi ; Ramos, Helena ; Ramsagar, Nastassja ; Rau, Cornelius ; Riault, Yoann ; Rojo Conejo, Pablo ; Clark, Basiimwa Roy ; Rubanga, Eddie ; Rubinga, Baker ; Ruklao, Chutima ; Runarassamee, Pattira ; Saenjum, Chalermpong ; Saewtrakool, Chayakorn ; Saidi, Yacine ; Sainz Costa, Talia ; Saisaengjan, Chutima ; Sakwa, Rebecca ; Sarfati, Tatiana ; Sbisi, Noshalaza ; Scheppers, Dihedile ; Schultze-Strasser, Stephan ; Schulze-Sturm, Ulf ; Scott, Karen ; Seeley, Janet ; Serunjogi, Robert ; Sewnarain, Leora ; Shakeshaft, Clare ; Sidhoo, Subashinie ; Shibemba, Mercy ; Shingadia, Delane ; Singh, Sheleika ; Sirirungsi, Wasna ; Sithebe, Sibongile ; Smit, Theresa ; Smith, Kurt ; Smuts, Marlize ; Spyer, Moira ; Sripaoraya, Worathip ; Srisuk, Warunee ; Ssenyonga, Mark ; Sudsaard, Patamawadee ; Sukrakanchana, Praornsuda ; Tearsansern, Pathanee ; Teixeira, Carla ; Than-In-At, Kanchana ; Thapwai, Thitiwat ; Thaweesombat, Yupawan ; Thewsoongnoen, Jutarat ; Thiébaut, Rodolphe ; Thomason, Margaret ; Thrasyvoulou, Laura ; Thungkham, Khanungnit ; Tikabibamu, Judith ; Tinago, Gloria ; Trairat, Ketmookda ; Tudor-Williams, Gareth ; Tukamushaba, Mercy ; Tukwasibwe, Deogratiuos ; Tumusiime, Julius ; Tuna, Joana ; Turner, Rebecca ; Udomvised, Arttasid ; Vadee, Aasia ; van Huyssteen, Hesti ; van Looy, Nadine ; Vaughan-Gordon, Yvonne ; Vecchia, Giulio ; Vowden, Richard ; Wampamba, Rebecca ; Welch, Steve ; Weller, Ian ; Weza, Sibusisiwe ; White, Ellen ; White, Ian ; Widuch, Kaja ; Wilkes, Helen ; Wimonklang, Sookpanee ; Wynne, Ben ; Yingyong, Pacharaporn ; Nakawungu, Zaam Zinda ; University College of London London (UCL) ; Radboud University Medical Center Nijmegen ; University of Zimbabwe (UZ) ; Baylor College of Medicine (BCM) ; University, Baylor ; University of Stellenbosch Business School Cape Town (USB ) ; Joint Clinical Research Centre ; University of the Witwatersrand Johannesburg (WITS) ; Johns Hopkins University (JHU) ; Equipe SPHERE (CERPOP) ; Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP) ; Université Toulouse III - Paul Sabatier (UT3) ; Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3) ; Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
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| Zeitschrift: | ISSN: 2352-3018 ; The Lancet HIV ; https://hal.science/hal-04543930 ; The Lancet HIV, 2022, 2022 |
| Veröffentlichung: | HAL CCSD, 2022 |
| Medientyp: | academicJournal |
| DOI: | 10.1016/S2352-3018(22)00160-6 |
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