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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
Authors :
Anna Turkova Hylke Waalewijn Man K Chan Pauline D J Bollen Mutsa F Bwakura-Dangarembizi Adeodata R Kekitiinwa Mark F Cotton Abbas Lugemwa Ebrahim Variava Grace Miriam Ahimbisibwe Ussanee Srirompotong Vivian Mumbiro Pauline Amuge Peter Zuidewind Shabinah Ali Cissy M Kityo Moherndran Archary Rashida A Ferrand Avy Violari Diana M Gibb David M Burger Deborah Ford Angela Colbers Amina Farhana Mehar (nee Abdulla) Pattamukkil Abraham Elaine Abrams Judith Acero Gerald Muzorah Agaba Grace Ahimbisibwe Barbara Ainebyoona Winnie Akobye Yasmeen Akhalwaya Nazim Akoojee Shabinah S. Ali Catherine Andrea Maria Angeles Muñoz Fernandez Rogers Ankunda Diana Antonia Rutebarika Suvaporn Anugulruengkitt Tsitsi Apollo Ronelle Arendze Juliet Ategeka Eunice Atim Lorna Atwine Abdel Babiker Sarah Babirye Enock Babu Edward Bagirigomwa Angella Baita David Balamusani Patsy Baliram David Baliruno Colin Ball Henry Balwa Alasdair Bamford Srini Bandi Dominique Barker Linda Barlow-Mosha Dickson Bbuye Shazia Begum Osee Behuhuma Sarah Bernays Rogers Besigye Maria Bester Joyline Bhiri Davide Bilardi Kristien Bird Pauline Bollen Chiara Borg Anne-Marie Borges Da Silva Jackie Brown Elena Bruno Torsak Bunupuradah David Burger Nomzamo Buthelezi Mutsa Bwakura-Dangarembizi Africanus Byaruhanga Joanna Calvert Petronelle Casey Haseena Cassim Sphiwee Cebekhulu Sanuphong Chailert Suwalai Chalermpantmetagul Wanna Chamjamrat Man Chan Precious Chandiwana Thannapat Chankun Sararut Chanthaburanun Nuttawut Chanto Ennie Chidziva Minenhle Chikowore Joy Chimanzi Dujrudee Chinwong Stuart Chitongo Moses Chitsamatanga Joshua Choga Duangrat Chutima Polly Clayden Alexandra Coelho Alexandra Compagnucci Ana Constança Mendes Magda Conway Mark F. Cotton Jane Crawley Tim R. Cressey Jacky Crisp Ana Cristina Matos Sumaya Dadan Jacqui Daglish Siva Danaviah Tseleng Daniel Anita De Rossi Sukanda Denjanta Els Dobbels Maria Dowie Prosper Dube Benedictor Dube Nimisha Dudakia Alice Elwana Cristina Epalza David Eram Juan Erasmus Peter Erim Luis Escosa Garcia Zaakirah Essack Carolina Estepa Monica Etima Alexandre Fernandes Maite Fernandez Felicity Fitzgerald Jacquie Flynn Claudia Fortuny Guasch Caroline Foster George Fourie Yolandie Fourie Sophie Foxall Derusha Frank Kate Gandhi India Garcia Kathleen Gartner Joshua Gasa Gugu Gasa Carlo Giaquinto Diana M. Gibb Coral Gomez Rico Daniel Gomez-Pena Secrecy Gondo Anna Goodman Maria Gorreti Nakalema Winnie Gozhora Pisut Greetanukroh Biobanco Gregorio Maranon Tiziana Grossele Shamiso Gwande Tapiwa Gwaze Tsitsi Gwenzi James Hakim Emmanuel Hakiza Abdul Hamid Kaka Ashley Harley Mornay Isaacs Richard Isabirye Wilber Ishemunyoro Tom Jacobs Lungile Jafta Nasir Jamil Anita Janse Janse van Rensburg Vinesh Jeaven Maria José Mellado Peña Gonzague Jourdain Katabalwa Juliet Thidarat Jumpimai Raungwit Junkaew Thidarat Jupimai Winfred Kaahwa Mildred Kabasonga Olivia Kaboggoza Rose Jacqueline Kadhuba Ampika Kaewbundit Kanyanee Kaewmamueng Bosco Kafufu Brenda Kakayi Phakamas Kamboua Suparat Kanjanavanit Gladys Kasangaki Naruporn Kasipong Miriam Kasozi Hajira Kataike Chrispus Katemba Elizabeth Kaudha Nkata Kekane Adeodata R. Kekitiinwa Edridah Keminyeto Woottichai Khamduang Warunee Khamjakkaew Jiraporn Khamkon Sasipass Khannak Orapin Khatngam Tassawan Khayanchoomnoom Busi Khumalo Mirriam Khunene Suwimon Khusuwan Phionah Kibalama Robinah Kibenge Anthony Kirabira Cissy M. Kityo Lameck Kiyimba Nigel Klein Soraya Klinprung Robin Kobbe Olivia Kobusingye Josephine Kobusungye Areerat Kongponoi Christoph Königs Olivier Koole Christelle Kouakam Nitinart Krueduangkam Namthip Kruenual Nuananong Kunjaroenrut Raymonds Kyambadde Priscilla Kyobutungi Flavia Kyomuhendo Erinah Kyomukama Reshma Lakha Cleopatra Langa Laddawan Laomanit Emily Lebotsa Prattana Leenasirimakul Lawrence Lekku Sarah Lensen Valériane Leroy Jin Li Afaaf Liberty Juthamas Limplertjareanwanich Emma Little Ezra Lutalo Jose Luis Jimenez Hermione Lyall Candice MacDonald Gladness Machache Penelope Madlala Tryphina Madonsela Nomfundo Maduna Joel Maena Apicha Mahanontharit Collin Makanga Candice Makola Shafic Makumbi Lucille Malgraaf Angelous Mamiane Felicia Mantkowski Wendy Mapfumo Laura Marques Agnes Mary Mugagga Lindiwe Maseko Tshepiso Masienyane Ruth Mathiba Farai Matimba Sajeeda Mawlana Emmanuel Mayanja Fatima Mayat Ritah Mbabazi Nokuthula Mbadaliga Faith Mbasani Kathleen McClaughlin Helen McIlleron Watchara Meethaisong Patricia Mendez Garcia Annet Miwanda Carlota Miranda Siphiwe Mkhize Kgosimang Mmolawa Rosie Mngqibisa Fatima Mohamed Tumelo Moloantoa Maletsatsi Monametsi Samuel Montero Cecilia L. Moore Rejoice Mosia Columbus Moyo Mumsy Mthethwa Shepherd Mudzingwa Tawona Mudzviti Hilda Mujuru Emmanuel Mujyambere Trust Mukanganiki Cynthia Mukisa Williams Mark Mulder Disan Mulima Alice Mulindwa Zivai Mupambireyi Alba Murciano Cabeza Herbert Murungi Dorothy Murungu Sandra Musarurwa Victor Musiime Alex V. Musiime Maria Musisi Philippa Musoke Barbara Musoke Nakirya Godfrey Musoro Sharif Musumba Sobia Mustafa Shirley Mutsai Phyllis Mwesigwa Rubondo Mariam Naabalamba Immaculate Nagawa Allemah Naidoo Shamim Nakabuye Sarah Nakabuye Sarah Nakalanzi Justine Nalubwama Annet Nalugo Stella Nalusiba Clementine Namajja Sylvia Namanda Paula Namayanja Esther Nambi Rachael Kikabi Namuddu Stella Namukwaya Florence Namuli Josephine Namusanje Rosemary Namwanje Anusha Nanan-kanjee Annet Nanduudu Charity Nankunda Joanita Nankya Baddokwaya Maria Nannungi Winnie Nansamba Kesdao Nanthapisal Juliet Nanyonjo Sathaporn Na-Rajsima Claire Nasaazi Helena Nascimento Eleni Nastouli Wipaporn Natalie Songtaweesin Kusum Nathoo Ian Natuhurira Rashidah Nazzinda Thabisa Ncgaba Milly Ndigendawani Makhosonke Ndlovu Georgina Nentsa Chaiwat Ngampiyaskul Ntombenhle Ngcobo Nicole Ngo Giang Huong Pia Ngwaru Ruth Nhema Emily Ninsiima Gloria Ninsiima Misheck Nkalo Phiri Antoni Noguera Julian Monica Nolan Thornthun Noppakaorattanamanee Muzamil Nsibuka Kisekka Eniola Nsirim Rashina Nundlal Rosita Nunes Lungile Nyantsa Mandisa Nyati Sean O'Riordan Paul Ocitti Labeja Denis Odoch Rachel Oguntimehin Martin Ojok Geoffrey Onen Wilma Orange Pradthana Ounchanum Benson Ouma Andreia Padrao Deborah Pako Anna Parker Malgorzata Pasko-Szcech Reena Patel Rukchanok Peongjakta Turian Petpranee Tasmin Phillips Jackie Philps Laura Picault Sonja Pieterse Helena Pinheiro Supawadee Pongprapass Anton Pozniak Andrew Prendergast Luis Prieto Tato Patcharee Puangmalai Thanyawee Puthanakit Modiehi Rakgokong Helena Ramos Nastassja Ramsagar Cornelius Rau Yoann Riault Pablo Rojo Conejo Basiimwa Roy Clark Eddie Rubanga Baker Rubinga Chutima Ruklao Pattira Runarassamee Chalermpong Saenjum Chayakorn Saewtrakool Yacine Saidi Talia Sainz Costa Chutima Saisaengjan Rebecca Sakwa Tatiana Sarfati Noshalaza Sbisi Dihedile Scheppers Stephan Schultze-Strasser Ulf Schulze-Sturm Karen Scott Janet Seeley Robert Serunjogi Leora Sewnarain Clare Shakeshaft Subashinie Sidhoo Mercy Shibemba Delane Shingadia Sheleika Singh Wasna Sirirungsi Sibongile Sithebe Theresa Smit Kurt Smith Marlize Smuts Moira Spyer Worathip Sripaoraya Warunee Srisuk Mark Ssenyonga Patamawadee Sudsaard Praornsuda Sukrakanchana Pathanee Tearsansern Carla Teixeira Kanchana Than-in-at Thitiwat Thapwai Yupawan Thaweesombat Jutarat Thewsoongnoen Rodolphe Thiébaut Margaret Thomason Laura Thrasyvoulou Khanungnit Thungkham Judith Tikabibamu Gloria Tinago Ketmookda Trairat Gareth Tudor-Williams Mercy Tukamushaba Deogratiuos Tukwasibwe Julius Tumusiime Joana Tuna Rebecca Turner Arttasid Udomvised Aasia Vadee Hesti Van Huyssteen Nadine Van Looy Yvonne Vaughan-Gordon Giulio Vecchia Richard Vowden Rebecca Wampamba Steve Welch Ian Weller Sibusisiwe Weza Ellen White Ian White Kaja Widuch Helen Wilkes Sookpanee Wimonklang Ben Wynne Pacharaporn Yingyong Zaam Zinda Nakawungu
Source :
The Lancet HIV, 9, e627-e637, The Lancet HIV, 9, 9, pp. e627-e637
Publication Year :
2022
Abstract
Contains fulltext : 282959.pdf (Publisher’s version ) (Open Access) 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
Details
ISSN :
24054704 and 23523018
Database :
OpenAIRE
Journal :
The Lancet HIV, 9, e627-e637, The Lancet HIV, 9, 9, pp. e627-e637
Accession number :
edsair.doi.dedup.....5fcd653c24284165b332697a9034e895