| Title: |
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 |
| Authors: |
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 |
| Contributors: |
University College London UCL (UCL); Radboud University Medical Center Nijmegen (RadboudUMC); University of Zimbabwe (UZ); Baylor College of Medicine (BCM); Baylor University; Stellenbosch Business School Stellenbosch University (SU); Stellenbosch University (SU); Joint Clinical Research Centre; University of the Witwatersrand Johannesburg (WITS); Johns Hopkins University Baltimore (JHU); Khon Kaen University Thailand (KKU); University of KwaZulu-Natal Durban, Afrique du Sud (UKZN); London School of Hygiene and Tropical Medicine (LSHTM); Equipe SPHERE (CERPOP); Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP); Université Toulouse III - Paul Sabatier (UT3); Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3); Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM); 206316/Z/17/Z/WT_/Wellcome Trust/United Kingdom UM1 AI069453/AI/NIAID NIH HHS/United States MC_UU_00004/03/MRC_/Medical Research Council/United Kingdom |
| Source: |
ISSN: 2352-3018 ; The Lancet HIV ; https://hal.science/hal-04543930 ; The Lancet HIV, 2022, 9 (9), pp.e627-e637. ⟨10.1016/S2352-3018(22)00160-6⟩. |
| Publisher Information: |
CCSD |
| Publication Year: |
2022 |
| Collection: |
Université Toulouse III - Paul Sabatier: HAL-UPS |
| Subject Terms: |
MESH: Adolescent; MESH: Child; MESH: Male; MESH: Oxazines; MESH: Piperazines; MESH: Pyridones; MESH: Rifampin / adverse effects; MESH: Tuberculosis / complications; MESH: Tuberculosis / drug therapy; MESH: Uganda; Preschool; MESH: Female; MESH: HIV Infections / complications; MESH: HIV Infections / drug therapy; MESH: HIV-1; MESH: Heterocyclic Compounds; 3-Ring; MESH: Humans; MESH: Infant; [SDV]Life Sciences [q-bio] |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/35868341; PUBMED: 35868341; PUBMEDCENTRAL: PMC9630157 |
| DOI: |
10.1016/S2352-3018(22)00160-6 |
| Availability: |
https://hal.science/hal-04543930; https://hal.science/hal-04543930v1/document; https://hal.science/hal-04543930v1/file/Turkova_2022.pdf; https://doi.org/10.1016/S2352-3018(22)00160-6 |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.8A738E5F |
| Database: |
BASE |