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5. Population Pharmacokinetic Modeling of Dolutegravir to Optimize Pediatric Dosing in HIV-1-Infected Infants, Children, and Adolescents

Author

Chandasana, Hardik, Thapar, Mita, Hayes, Siobhan, Baker, Mark, Gibb, Diana M., Turkova, Anna, Ford, Deborah, Ruel, Theodore, Wiznia, Andrew, Fairlie, Lee, Bwakura-Dangarembizi, Mutsa, Mujuru, Hilda, Alvero, Carmelita, Farhad, Mona, Hazra, Rohan, Townley, Ellen, Buchanan, Ann, Bollen, Pauline, Waalewijn, Hylke, Colbers, Angela, Burger, David, Acosta, Edward P., and Singh, Rajendra

Published
2023
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6. 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

Author

Mehar (nee Abdulla), Amina Farhana, Abraham, Pattamukkil, Abrams, Elaine, Acero, Judith, Agaba, Gerald Muzorah, Ahimbisibwe, Grace, Ainebyoona, Barbara, Akobye, Winnie, Akhalwaya, Yasmeen, Akoojee, Nazim, Ali, Shabinah S., Amuge, Pauline, Andrea, Catherine, Muñoz Fernandez, Maria Angeles, Ankunda, Rogers, Rutebarika, Diana Antonia, Anugulruengkitt, Suvaporn, Apollo, Tsitsi, Archary, Moherndran, 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, Bollen, Pauline, Borg, Chiara, Borges Da Silva, Anne-Marie, Brown, Jackie, Bruno, Elena, Bunupuradah, Torsak, Burger, David, Buthelezi, Nomzamo, Bwakura-Dangarembizi, Mutsa, Byaruhanga, Africanus, Calvert, Joanna, Casey, Petronelle, Cassim, Haseena, Cebekhulu, Sphiwee, Chailert, Sanuphong, Chalermpantmetagul, Suwalai, Chamjamrat, Wanna, Chan, Man, 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, Colbers, Angela, Compagnucci, Alexandra, Constança Mendes, Ana, Conway, Magda, Cotton, Mark F., Crawley, Jane, Cressey, Tim R., 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, Ford, Deborah, 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, Gibb, Diana M., 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, Kekitiinwa, Adeodata R., 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, Kityo, Cissy M., 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, Lugemwa, Abbas, 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 L., 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, Mumbiro, Vivian, Mupambireyi, Zivai, Murciano Cabeza, Alba, Murungi, Herbert, Murungu, Dorothy, Musarurwa, Sandra, Musiime, Victor, Musiime, Alex V., 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, Srirompotong, Ussanee, 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, Turkova, Anna, Turner, Rebecca, Udomvised, Arttasid, Vadee, Aasia, Van Huyssteen, Hesti, Van Looy, Nadine, Variava, Ebrahim, Vaughan-Gordon, Yvonne, Vecchia, Giulio, Violari, Avy, Vowden, Richard, Waalewijn, Hylke, 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, Zuidewind, Peter, Chan, Man K, Bollen, Pauline D J, Bwakura-Dangarembizi, Mutsa F, Kekitiinwa, Adeodata R, Cotton, Mark F, Ahimbisibwe, Grace Miriam, Ali, Shabinah, Kityo, Cissy M, Ferrand, Rashida A, Gibb, Diana M, and Burger, David M

Published
2022
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7. 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

Author

Mehar (nee Abdulla), Amina Farhana, Abraham, Pattamukkil, Abrams, Elaine, Acero, Judith, Agaba, Gerald Muzorah, Ahimbisibwe, Grace, Ainebyoona, Barbara, Akobye, Winnie, Akhalwaya, Yasmeen, Akoojee, Nazim, Ali, Shabinah S., Amuge, Pauline, Andrea, Catherine, Muñoz Fernandez, Maria Angeles, Ankunda, Rogers, Rutebarika, Diana Antonia, Anugulruengkitt, Suvaporn, Apollo, Tsitsi, Archary, Moherndran, 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, Bollen, Pauline, Borg, Chiara, Borges Da Silva, Anne-Marie, Brown, Jackie, Bruno, Elena, Bunupuradah, Torsak, Burger, David, Buthelezi, Nomzamo, Bwakura-Dangarembizi, Mutsa, Byaruhanga, Africanus, Calvert, Joanna, Casey, Petronelle, Cassim, Haseena, Cebekhulu, Sphiwee, Chailert, Sanuphong, Chalermpantmetagul, Suwalai, Chamjamrat, Wanna, Chan, Man, 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, Colbers, Angela, Compagnucci, Alexandra, Constança Mendes, Ana, Conway, Magda, Cotton, Mark F., Crawley, Jane, Cressey, Tim R., 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, Ford, Deborah, 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, Gibb, Diana M., 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, Kekitiinwa, Adeodata R., 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, Kityo, Cissy M., 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, Lugemwa, Abbas, 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 L., 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, Mumbiro, Vivian, Mupambireyi, Zivai, Murciano Cabeza, Alba, Murungi, Herbert, Murungu, Dorothy, Musarurwa, Sandra, Musiime, Victor, Musiime, Alex V., 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, Srirompotong, Ussanee, 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, Turkova, Anna, Turner, Rebecca, Udomvised, Arttasid, Vadee, Aasia, Van Huyssteen, Hesti, Van Looy, Nadine, Variava, Ebrahim, Vaughan-Gordon, Yvonne, Vecchia, Giulio, Violari, Avy, Vowden, Richard, Waalewijn, Hylke, 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, Zuidewind, Peter, Mujuru, Hilda A, Kityo, Cissy M, Turner, Rebecca M, Ali, Shabinah, Nathoo, Kusum J, Mosala, Modehei, Kekitiinwa, Adeodata R, Rojo, Pablo, and Gibb, Diana M

Published
2022
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8. Estimating the impact of alternative programmatic cotrimoxazole strategies on mortality among children born to mothers with HIV: A modelling study

Author

Mathur, Shrey, Smuk, Melanie, Evans, Ceri, Wedderburn, Catherine J., Gibb, Diana M., Penazzato, Martina, and Prendergast, Andrew J.

Subjects
EPUB (Standard), HIV (Viruses), HIV testing, Mortality -- Uganda -- Côte d'Ivoire -- Mozambique -- Zimbabwe, Evidence (Law), Drug resistance in microorganisms, Antiviral agents, Highly active antiretroviral therapy, Children -- Health aspects, Disease transmission, Biological sciences, World Health Organization
Abstract

Background World Health Organization (WHO) guidelines recommend cotrimoxazole prophylaxis for children who are HIV-exposed until infection is excluded and vertical transmission risk has ended. While cotrimoxazole has benefits for children with HIV, there is no mortality benefit for children who are HIV-exposed but uninfected, prompting a review of global guidelines. Here, we model the potential impact of alternative cotrimoxazole strategies on mortality in children who are HIV-exposed. Methods and findings Using a deterministic compartmental model, we estimated mortality in children who are HIV-exposed from 6 weeks to 2 years of age in 4 high-burden countries: Côte d'Ivoire, Mozambique, Uganda, and Zimbabwe. Vertical transmission rates, testing rates, and antiretroviral therapy (ART) uptake were derived from UNAIDS data, trial evidence, and meta-analyses. We explored 6 programmatic strategies: maintaining current recommendations; shorter cotrimoxazole provision for 3, 6, 9, or 12 months; and starting cotrimoxazole only for children diagnosed with HIV. Modelled alternatives to the current strategy increased mortality to varying degrees; countries with high vertical transmission had the greatest mortality. Compared to current recommendations, starting cotrimoxazole only after a positive HIV test had the greatest predicted increase in mortality: Mozambique (961 excess annual deaths; excess mortality 339 per 100,000 HIV-exposed children; risk ratio (RR) 1.06), Uganda (491; 221; RR 1.04), Zimbabwe (352; 260; RR 1.05), and Côte d'Ivoire (125; 322; RR 1.06). Similar effects were observed for 3-, 6-, 9-, and 12-month strategies. Increased mortality persisted but was attenuated when modelling lower cotrimoxazole uptake, smaller mortality benefits, higher testing coverage, and lower vertical transmission rates. The study is limited by uncertain estimates of cotrimoxazole coverage in programmatic settings; an inability to model increases in mortality arising from antimicrobial resistance due to limited surveillance data in sub-Saharan Africa; and lack of a formal health economic analysis. Conclusions Changing current guidelines from universal cotrimoxazole provision for children who are HIV-exposed increased predicted mortality across the 4 modelled high-burden countries, depending on test-to-treat cascade coverage and vertical transmission rates. These findings can help inform policymaker deliberations on cotrimoxazole strategies, recognising that the risks and benefits differ across settings., Author(s): Shrey Mathur 1,*, Melanie Smuk 1, Ceri Evans 1,2,3, Catherine J. Wedderburn 4,5, Diana M. Gibb 4, Martina Penazzato 6, Andrew J. Prendergast 1,2 Introduction Vertical transmission of HIV [...]

Published
2024
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9. Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

Author

Mehar (nee Abdulla), Amina Farhana, Abraham, Pattamukkil, Abrams, Elaine, Acero, Judith, Agaba, Gerald Muzorah, Ahimbisibwe, Grace, Ainebyoona, Barbara, Akobye, Winnie, Akhalwaya, Yasmeen, Akoojee, Nazim, Ali, Shabinah S., Amuge, Pauline, Andrea, Catherine, Muñoz Fernandez, Maria Angeles, Ankunda, Rogers, Rutebarika, Diana Antonia, Anugulruengkitt, Suvaporn, Apollo, Tsitsi, Archary, Moherndran, 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, Bollen, Pauline, Borg, Chiara, Borges Da Silva, Anne-Marie, Brown, Jackie, Bruno, Elena, Bunupuradah, Torsak, Burger, David, Buthelezi, Nomzamo, Bwakura-Dangarembizi, Mutsa, Byaruhanga, Africanus, Calvert, Joanna, Casey, Petronelle, Cassim, Haseena, Cebekhulu, Sphiwee, Chailert, Sanuphong, Chalermpantmetagul, Suwalai, Chamjamrat, Wanna, Chan, Man, 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, Colbers, Angela, Compagnucci, Alexandra, Constança Mendes, Ana, Conway, Magda, Cotton, Mark F, Crawley, Jane, Cressey, Tim R, 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, Ford, Deborah, 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, Gibb, Diana M, 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, Kekitiinwa, Adeodata R, 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, Kityo, Cissy M, 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, Lugemwa, Abbas, 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 L, 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, Mumbiro, Vivian, Mupambireyi, Zivai, Murciano Cabeza, Alba, Murungi, Herbert, Murungu, Dorothy, Musarurwa, Sandra, Musiime, Victor, Musiime, Alex V, 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, Srirompotong, Ussanee, 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, Turkova, Anna, Turner, Rebecca, Udomvised, Arttasid, Vadee, Aasia, Van Huyssteen, Hesti, Van Looy, Nadine, Variava, Ebrahim, Vaughan-Gordon, Yvonne, Vecchia, Giulio, Violari, Avy, Vowden, Richard, Waalewijn, Hylke, 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, Zuidewind, Peter, Ahimbisibwe, Grace Miriam, Mosia, Nozibusiso Rejoice, Fortuny, Clàudia, Bwakura-Dangarembizi, Mutsa F, Mujuru, Hilda A, Kityo, Cissy, Ferrand, Rashida A, and Rojo, Pablo

Published
2023
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10. Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV – Week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial

Author

Compagnucci, A., Saidi, Y., Riault, Y., Coelho, A., Kouakam, C., Picault, L., Ndiaye, M., Meyer, L., Cagnot, C., Circosta, S., Léger, L., Simanic, S., Arulananthan, A., Gibb, D.M., Babiker, A., Chan, M., Ford, D., Hudson, F., Harper, L., Bamford, A., Nolan, A., Widuch, K., Townsend, S., Van-Looy, N., Gao, L., Little, E., Turkova, A., Fabiane, S., Calvert, J., Blackstone, J., Scott, K., Inshaw, J., Nunn, A., Nardone, A., Bilardi, D., Cressey, T.R., Chalermpantmetagul, S., Khamduang, W., Jourdain, G., Ngo Giang Huong, N., Chinwong, D., Saenjum, C., Peongjakta, R., Sukrakanchana, P., Laomanit, L., Kaewbundit, A., Khamkon, J., Than-in-at, K., Meeboon, C., Sripaoraya, W., Krueduangkam, N., Kruenual, N., Khamjakkaew, W., Klinprung, S., Giaquinto, C., Morkunaite, G., Hirt, D., Prieto Tato, L., Niehues, T., Plonné, D., Morén, C., Noguera, T., Muñoz Fernández, M.A., Bologna, R., Arazi, S., Fedullo, A.G., Taicz, M., Vicentini, E., Moragas, M., Mangano, A., Dell’Orso, M., Gatto, M., Reliquet, V., Soria, A., Paredes, E., Chereau, N., Tching Sin, M., Flet, L., Rodallec, A., Hemon, C., Elenga, N., Terrine, M.D., Blaise, N., Augustin, S., Mespoulhe, P., Pouchain, H., Pavia-Ruz, N., Muñoz- Hernández, R., Neri-Macias, A., Jarillo-Quijada, M.D., Espinosa-Sotero, C., Marques, L., Teixeira, C., Fernandes, A., Nunes, R., Nascimento, H., Tuna, J., Padrao, A., Ferraz, I., Mendes, A.C., Correira, C., Pinheiro, H., Matos, A.C., Sampaio, A.C., Oliveira, A., Caldeira, A., Tavares, M., Reis Melo, A., Castro, C., Faria, C., Prucha, C., Ribeiro, R., Monteiro, F., Candeias, M.F., Silva Milhiero, T., Gomes Neves, E., Corte-Real, R., Morgado, M., Mendes, D., Cardão, M., Violari, A., Ramsagar, N., Liberty, A., Nyati, M., Maseko, L., Khunene, M., Mkhize, S., Essack, Z., Akoojee, N., Singh, U., Fourie, Y., Govender, S., Vadee, A., Lakha, R., Erasmus, J., Mamiane, A., Daniel, T., Bhana, P., Maduna, N., Cotton, M., Groenewald, M., Slade, G., Coetzee, J., Ganger, L., Weldon, S., Wessels, M., Hoorn, L., Pieterse, S., Makola, C., Smith, K., Isaacs, M., Cweya, A., Fry, S., Barnabas, S., Theunissen, M., Nduna, N., Smuts, M., Rojo Conejo, P., Epalza, C., Fernández, M., Mellado Peña, M.J., Sainz Costa, T., Escosa García, L., Gomez Salcedo, P., Fortuny Guasch, C., Noguera Julian, T., Estepa, C., Cubells, M., Sans, E., Bruno, E., Prieto, L., Mendez García, P., Murciano Cabeza, A., Coto, M., Torrent, R., Torres Arauz, M., Navarro Gómez, M., Mur, A., Guillén Martin, S., Moreno, M., Ramos Amador, J.T., Garcia, I., Kalhert, C., Wachinger, T., Wohlwend, B., Hafner, S., Dollenmaier, G., Paioni, P., Signorell, R., Boni, J., Duppenthaler, A., Mann, B., Saegesser, C., Barbani, M., Ngampiyaskul, C., Greetanukroh, P., Khannak, P., Tearsansern, P., Chamjamrat, W., Chanto, N., Thapwai, T., Thungkham, K., Puangmalai, P., Ruklao, C., Ounchanum, P., Khusuwan, S., Denjanta, S., Thaweesombat, Y., Thewsoongnoen, J., Kaewmamueng, K., Kamboua, P., Pongprapass, S., Srisuk, W., Kongponoi, A., Limplertjareanwanich, J., Kanjanavanit, S., Saewtrakool, C., Yingyong, P., Chutima, D., Junkaew, R., Chankun, T., Srirompotong, U., Sudsaard, P., Kongsuk, K., Petpranee, T., Srirojana, S., Donngernl, D., Kamkoonmongkol, A., Na Kalasin, N., Phunkhum, P., Kekitiinwa, A.R., Amuge, P., Bbuye, D., Nalubwama, J., Namanda, S., Nsibuka Kisekka, M., Kirabira, A., Lawrence, L., Agaba, G., Ahimbisibwe, G., Nalugo, A., Namuli, F., Kadhuba, R., Namuddu, R., Nabwire, I., Kiyimba, L., Baita, A., Tikabibamu, J., Nakandi, L., Kisitu, G.P., Nabukeera Barung, N., Kityo, C.M., Musiime, V., Kaudha, E., Nanduudu, A., Mujyambere, E., Labeja Ocitti, S.P., Ategeka, J., Nambi, E., Nazzinda, R., Rutebarika, D., Basiimwa, R., Mbabazi, R., Kyobutungi, P., Nabalamba, M., Nakalyango, A., Tumusiime, J., Nakabuye, S., Mwebaza, J., Oruk, S., Namusanje, J., Musiime, A., Mugarura, L., Ojok, M., Kitabalwa, J., Katemba, C., Nannungi, M., Bagirigomwa, E., Odoch, D., Rubanga, E., Mulima, D., Babu, E.L., Baliruno, D., Inyakuwal, C., Williams, E.D., Mulindwa, A., Uyungrwoth, A., Raus, I., Mostovenko, O., Stepchenkova, T., Volokha, A., Primak, N., Kenny, J., Callaghan, A., Ahmad, M., Vergnano, S., Ross, M., Manyi, F., Nayagam, D., Hawkins, S., Ball, C., Hamlyn, E., Gilmour, C., Gilmour-White, S., Doshi, S., Fuller, E., Adebayo, A., Tupper, K., Nsirim, E., Welch, S., Daglish, J., Thrasyvoulou, L., Irvine, E., Gandhi, K., Vaughn-Gordon, Y., Sibanda, N., Compagnucci, Alexandra, Chan, Man K., Saïdi, Yacine, Cressey, Tim R., Bamford, Alasdair, Riault, Yoann, Coelho, Alexandra, Nolan, Aoife, Chalermpantmetagul, Suwalai, Morkunaite, Gabija, Amuge, Pauline, Musiime, Victor, Violari, Avy, Cotton, Mark, Kekitiinwa, Adeodata R., Kaudha, Elizabeth, Groenewald, Marisa, Liberty, Afaaf A., Kanjanavanit, Suparat, Volokha, Alla, Bologna, Rosa, Pavia Ruz, Noris, Prieto Tato, Luis, Paioni, Paolo, Marques, Laura, Reliquet, Véronique, Niehues, Tim, Welch, Steven B., Ford, Deborah, Giaquinto, Carlo, Gibb, Diana M., Babiker, Abdel, and Ramos Amador, Jose Tomas

Published
2023
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11. Inadequate Lopinavir Concentrations With Modified 8-Hourly Lopinavir/Ritonavir 4: 1 Dosing During Rifampicin-based Tuberculosis Treatment in Children Living With HIV

Author

Chabala, Chishala, Turkova, Anna, Kapasa, Monica, LeBeau, Kristen, Tembo, Chimuka H., Zimba, Kevin, Weisner, Lubbe, Zyambo, Khozya, Choo, Louise, Chungu, Chalilwe, Lungu, Joyce, Mulenga, Veronica, Crook, Angela, Gibb, Diana, McIlleron, Helen, Gibb, Diana M., Turkova, Anna, Crook, Angela M., Choo, Louise, Wills, Genevieve, Thomason, Margaret J., Teera, Jaqueline, Owen- Powell, Ellen, LeBeau, Kristen, Baptiste, David, McGowan, Charlotte, Spyer, Moira, Chabala, Chishala, Mulenga, Veronica, Lungu, Joyce, Kapasa, Monica, Zimba, Kevin, Zyambo, Khozya, Chungu, Chalilwe, Tembo, Chimuka, Kunda, Sharon, Shingalili, Ellen, Zulu, Semy, Chipoya, Terence, Mwanakalanga, Habulembe, Chambela, Elias, Hankombo, Jessy M., Kalumbi, Mox Malama, Chola, Daniel, Malama, Stephen, Wobudeya, Eric, Musoke, Philippa, Baldwin, Mboizi Robert, Nansamba, Winnie, Ssenyonga, Mark, Ssengooba, Willy, Businge, Gerald, Hesseling, Anneke C., Palmer, Megan, van der Zalm, Marieke M., Workman, Jessica, Demers, Anne-Marie, Schaaf, Simon, Gie, Robert, Walters, Elisabetta, Zimri, Warren, Hoddinott, Graeme, Deventer, Anneen van, Goussard, Pierre, Morrison, Julie, Mave, Vidya, (PI), Kinikar, Aarti Avinash, Raichur, Priyanka, Nijampurkar, Aparna, Khan, Sameer, Hissar, Syed, Joseph, Bency, Bhavani, Perumal Kannabiran, Prathiksha, G, Baskaran, Dhanaraj, Gomathi, NS, Mythily, V, Kumar, Hemanth, Chelvi, Silambu, Sekar, L, Hanna, Luke, Ramesh, K, Latha, Hema, Bharathi, S, Banu, Parveen, Xavier, Dino, Kumar, Manjith, Guru, K, Kumar, Sasi, Kesavan, A, Gunasundari, A, Mangalambal, G, Nagarajan, Valarmathi, Shankar, Shakeela, Selvi, R, Vaishnavi, S, Yadav, Krishna, Supriya, R, Giranab, Hema, Seetha, A, Mary, Stella, Gopika, S, Rohini, S, Revathy, M, Balaji, Sarath, Elilarasi, S, Ganesh, J, Aravind, MA, Mulambo, Sylvia, Mwanyungwi, Hope, Tapse, Dharati, Sane, Manasi, Abdullah, Amina, Nakalanzi, Sarah, Williams, Cynthia Mukisa, McIlleron, Helen, Aarnoutse, Rob, Revill, Paul, Love-Koh, James, Walker, Simon, Mugyenyi, Peter, Darbyshire, Janet, Clayden, Polly, Donald, Peter, Singh, Varinder, Grzemska*, Malgosia, Swaminathan, Soumya, Verkuijl, *Replaced by Sabine, Peto, Tim, Mwinga, Alwyn, Fielding, Katherine, Graham, Stephen M., Welch, Steven B., Seddon, James A., Whittaker, Elizabeth, Anderson, Suzanne, and Grandjean, Louis

Published
2023
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12. 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

Author

Barlow‐Mosha, Linda Namutebi, Ahimbisibwe, Grace Miriam, Chappell, Elizabeth, Amuge, Pauline Mary, Nanduudu, Annet, Kaudha, Elizabeth, Amukele, Timothy, Balamusani, David, Kafufu, Bosco, Nimwesiga, Audrey, Kataike, Hajira, Namwanje, Rosemary, Kasangaki, Gladys, Mulindwa, Alice, Muzorah, Gerald Agaba, Bbuye, Dickson, Musiime, Victor, Mujyambere, Emmanuel, Ssenyonga, Mark, Mulima, Disan, Kyambadde, Raymonds Crespo, Namusanje, Josephine, Isabirye, Richard, Nabalamba, Mariam, Nakirya, Barbara Musoke, Kityo, Cissy, Kekitiinwa, Adeodata R., Giaquinto, Carlo, Copp, Andrew, Gibb, Diana M., Ford, Deborah, Musoke, Philippa, and Turkova, Anna

Subjects
Folic acid -- Health aspects, HIV infection in children -- Drug therapy, Vitamin B12 -- Health aspects, Drug interactions -- Observations, Health
Abstract

: Introduction: Dolutegravir‐based antiretroviral therapy (ART) is the preferred antiretroviral treatment for children and adolescents living with HIV. A large surveillance study in Botswana previously raised concerns about an association between pre‐conception dolutegravir and neural tube defects. Before these concerns were subsequently resolved, we set up a sub‐study to look at the effect of dolutegravir on levels of folate and vitamin B12 in children and adolescents within the randomized ODYSSEY trial, as folate and vitamin B12 are known to play a crucial role in neural tube development. Methods: We conducted the sub‐study among Ugandan ODYSSEY participants and compared folate and vitamin B12 between children randomized to dolutegravir‐based ART (DTG) and non‐dolutegravir‐based standard‐of‐care treatment (SOC). Plasma folate was measured at enrolment and week 4 on stored samples; in addition, plasma and red blood cell (RBC) folate and vitamin B12 were assayed at week ≥96 in prospectively collected samples. RBC mean corpuscular volume (MCV) was measured 24‐weekly in all ODYSSEY participants. Samples analysed in the sub‐study were collected between September 2016 and October 2020. Results: A total of 229 children aged ≥6 years were included in the sub‐study with median age at trial enrolment of 12.3 (interquartile range [IQR] 9.0, 14.7) years, and CD4 count of 501 (IQR 228, 695); 112 (49%) children were male. Most participants (225/229, 98%) had plasma folate results at enrolment and 214 (93%) children had results available for RBC folate, vitamin B12 and plasma folate at week ≥96. MCV results were analysed on 679 children aged ≥6 years enrolled in ODYSSEY. At week 4, mean plasma folate was significantly higher in the dolutegravir arm than in SOC (difference [DTG‐SOC] 1.6 ng/ml, 95% CI 0.8, 2.3; p Conclusions: Plasma and RBC folate levels were higher in children and adolescents receiving dolutegravir‐based ART than on other ART regimens. Further studies are needed to clarify the mechanisms of these interactions and the clinical implications of increased blood folate levels., INTRODUCTION Dolutegravir‐based antiretroviral therapy (ART) has become the preferred treatment option for children living with HIV due to superior efficacy and similar safety compared to non‐dolutegravir‐based ART [1]. A number [...]

Published
2023
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13. Borrowing information across patient subgroups in clinical trials, with application to a paediatric trial

Author

Turner, Rebecca M., Turkova, Anna, Moore, Cecilia L., Bamford, Alasdair, Archary, Moherndran, Barlow-Mosha, Linda N., Cotton, Mark F., Cressey, Tim R., Kaudha, Elizabeth, Lugemwa, Abbas, Lyall, Hermione, Mujuru, Hilda A., Mulenga, Veronica, Musiime, Victor, Rojo, Pablo, Tudor-Williams, Gareth, Welch, Steven B., Gibb, Diana M., Ford, Deborah, and White, Ian R.

Published
2022
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14. 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

Author

Waalewijn, Hylke, Chan, Man K, Bollen, Pauline D J, Mujuru, Hilda A, Makumbi, Shafic, Kekitiinwa, Adeodata R, Kaudha, Elizabeth, Sarfati, Tatiana, Musoro, Godfrey, Nanduudu, Annet, Lugemwa, Abbas, Amuge, Pauline, Moore, Cecilia L, Rojo, Pablo, Giaquinto, Carlo, Colbers, Angela, Gibb, Diana M, Ford, Deborah, Turkova, Anna, and Burger, David M

Published
2022
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15. Whole blood versus red cell concentrates for children with severe anaemia: a secondary analysis of the Transfusion and Treatment of African Children (TRACT) trial

Author

Maitland, Kathryn, Walker, Sarah A, George, Elizabeth C, Williams, Thomas N, Gibb, Diana M, Mpoya, Ayub, Frost, Gary, Walsh, Kevin, Olupot-Olupot, Peter, Nteziyaremye, Julius, Namayanja, Cate, Ssenyondo, Tonny, Passi, George, Muhindo, Rita, Masifa, George, Adong, Ruth, Okalebo, Charles B, Atimango, Emmanuela, Thembo, Nobert, Odong, George, Kiluli, Godfrey, Kapsindet, Job, Kiguli, Sarah, Opoka, Robert O, Kayaga, Julianne, Nabawanuka, Eva, Kadama, Eva, Mukisa, Cynthia Williams, Engoru, Charles, Alaroker, Florence, Nakuya, Margaret, Amorut, Denis, Olupot, Moses, Onyas, Pius, Ariimi, Margaret, Itipe, Melda, Atim, Mary G, Abeno, Mary, Okwi, Steven, Kulume, Mary G, Among, Grace, Achipa, Dorreen E, Uyoga, Sophie, Macharia, Alex, Mellewa, Machpherson, Chagaluka, George, Kennedy, Neil, Kumwenda, Felistas, Sochera, Tiferanji Fatch, Malenga, Albert, Chimalizeni, Yamikani FG, Gushu, Benard, Phiri, Tusekile, Chesale, Amisa, Mitole, Ndaona, Chokani, Ellida, Munthali, Annie, Hensbroek, Michael Boele von, South, Annabelle, Thomason, Margaret J, Baptiste, David, Connon, Roisin, MacCabe, Leanne, Ali, Abdul, Khamis, Kibibi, Madoola, Macreen, Abongo, Grace, Bates, Imelda, Urban, Britta, Heydermann, Robert, Kyomuhendo, Flavia, Nakalanzi, Sarah, Chabuka, John, Mkandawire, Nkhafwire, Fitzgerald, Felicity, Evans, Jennifer A, Molyneux, Elizabeth, Lubega, Irene, Crawley, Jane, Kazembe, Peter, Murphy, Mike, Peto, Tim, Todd, Jim, Mirembe, Grace, Musoka, Philipa, Tenu, Filemoni, M'baya, Bridon, Kyeyune Byabazair, Dorothy, Mbanya, Dora, and Walker, A Sarah

Published
2022
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16. Population Pharmacokinetics of Dolutegravir in African Children: Results From the CHAPAS-4 Trial.

Author

Waalewijn, Hylke, Wasmann, Roeland E, Bamford, Alasdair, Gibb, Diana M, McIlleron, Helen M, Colbers, Angela, Burger, David M, Denti, Paolo, and team, the CHAPAS-4 trial

Subjects
AFRICANS, SECONDARY analysis, TENOFOVIR, HIV infections, DESCRIPTIVE statistics, EMTRICITABINE, PHARMACOKINETICS, ANTI-HIV agents, BIOAVAILABILITY, CONFIDENCE intervals, CHILDREN
Abstract

We characterized population pharmacokinetics in 42 African children receiving once-daily 25 mg (14 to <20 kg) or 50 mg (>20 kg) dolutegravir. Coadministration with emtricitabine and tenofovir alafenamide reduced dolutegravir bioavailability by 19.6% (95% confidence interval: 8.13%–30.8%) compared with zidovudine or abacavir with lamivudine. Nevertheless, concentrations remained above efficacy targets, confirming current dosing recommendations. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Co‐trimoxazole prophylaxis for children who are HIV‐exposed and uninfected: a systematic review

Author

Wedderburn, Catherine J., Evans, Ceri, Slogrove, Amy L., Rehman, Andrea M., Gibb, Diana M., Prendergast, Andrew J., and Penazzato, Martina

Subjects
Co-trimoxazole -- Dosage and administration, Maternal-fetal exchange -- Health aspects, Secondary data analysis -- Management, HIV infection -- Physiological aspects, Company business management, Health
Abstract

: Introduction: Co‐trimoxazole prophylaxis is recommended for children born to women with HIV to protect those who acquire HIV from opportunistic infections, severe bacterial infections and malaria. With scale‐up of maternal antiretroviral therapy, most children remain HIV‐exposed uninfected (HEU) and the benefits of universal co‐trimoxazole are uncertain. We assessed the effect of co‐trimoxazole on mortality and morbidity of children who are HEU. Methods: We performed a systematic review (PROSPERO number: CRD42021215059). We systematically searched MEDLINE, Embase, Cochrane CENTRAL, Global Health, CINAHL Plus, Africa‐Wide Information, SciELO and WHO Global Index Medicus for peer‐reviewed articles from inception to 4th January 2022 without limits. Ongoing randomized controlled trials (RCTs) were identified through registries. We included RCTs reporting mortality or morbidity in children who are HEU receiving co‐trimoxazole versus no prophylaxis/placebo. The risk of bias was assessed using the Cochrane 2.0 tool. Data were summarized using narrative synthesis and findings were stratified by malaria endemicity. Results: We screened 1257 records and included seven reports from four RCTs. Two trials from Botswana and South Africa of 4067 children who are HEU found no difference in mortality or infectious morbidity in children randomized to co‐trimoxazole prophylaxis started at 2–6 weeks of age compared to those randomized to placebo or no treatment, although event rates were low. Sub‐studies found that antimicrobial resistance was higher in infants receiving co‐trimoxazole. Two trials in Uganda investigating prolonged co‐trimoxazole after breastfeeding cessation showed protection against malaria but no other morbidity or mortality differences. All trials had some concerns or a high risk of bias, which limited the certainty of evidence. Discussion: Studies show no clinical benefit of co‐trimoxazole prophylaxis in children who are HEU, except to prevent malaria. Potential harms were identified for co‐trimoxazole prophylaxis leading to antimicrobial resistance. The trials in non‐malarial regions were conducted in populations with low mortality potentially reducing generalizability to other settings. Conclusions: In low‐mortality settings with few HIV transmissions and well‐performing early infant diagnosis and treatment programmes, universal co‐trimoxazole may not be required., INTRODUCTION Vertical transmission of HIV has declined enormously over recent years due to the widespread scale‐up of antiretroviral therapy (ART) among pregnant and breastfeeding women. However, despite this marked progress, [...]

Published
2023
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18. Subcortical Brain Volumes and Neurocognitive Function in Children With Perinatal HIV Exposure: A Population-Based Cohort Study in South Africa.

Author

Wedderburn, Catherine J, Yeung, Shunmay, Groenewold, Nynke A, Rehman, Andrea M, Subramoney, Sivenesi, Fouche, Jean-Paul, Joshi, Shantanu H, Narr, Katherine L, Hoffman, Nadia, Roos, Annerine, Gibb, Diana M, Zar, Heather J, Stein, Dan J, and Donald, Kirsten A

Subjects
BASAL ganglia, TODDLERS development, BRAIN anatomy, CHILD development, INFANT development
Abstract

Background Children who are HIV-exposed and uninfected (HEU) are at risk for early neurodevelopmental impairment. Smaller basal ganglia nuclei have been reported in neonates who are HEU compared to HIV-unexposed (HU); however, neuroimaging studies outside infancy are scarce. We examined subcortical brain structures and associations with neurocognition in children who are HEU. Methods This neuroimaging study was nested within the Drakenstein Child Health Study birth cohort in South Africa. We compared (T1-weighted) magnetic resonance imaging–derived subcortical brain volumes between children who were HEU (n = 70) and HU (n = 92) at age 2–3 years using linear regression. Brain volumes were correlated with neurodevelopmental outcomes measured with the Bayley Scales of Infant and Toddler Development III. Results Compared to HU children, on average children who were HEU had 3% lower subcortical grey matter volumes. Analyses of individual structures found smaller volume of the putamen nucleus in the basal ganglia (−5% difference, P =.016) and the hippocampus (−3% difference, P =.044), which held on adjustment for potential confounders (P <.05). Maternal viremia and lower CD4 count in pregnancy were associated with smaller child putamen volumes. Children who were HEU had lower language scores than HU; putamen and hippocampus volumes were positively correlated with language outcomes. Conclusions Overall, children who are HEU had a pattern of smaller subcortical volumes in the basal ganglia and hippocampal regions compared to HU children, which correlated with language function. Findings suggest that optimizing maternal perinatal HIV care is important for child brain development. Further studies are needed to investigate underlying mechanisms and long-term outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

Author

Bollen, Pauline D J, Moore, Cecilia L, Mujuru, Hilda A, Makumbi, Shafic, Kekitiinwa, Adeodata R, Kaudha, Elisabeth, Parker, Anna, Musoro, Godfrey, Nanduudu, Annet, Lugemwa, Abbas, Amuge, Pauline, Hakim, James G, Rojo, Pablo, Giaquinto, Carlo, Colbers, Angela, Gibb, Diana M, Ford, Deborah, Turkova, Anna, and Burger, David M

Published
2020
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22. The cost-effectiveness of prophylaxis strategies for individuals with advanced HIV starting treatment in Africa

Author

Walker, Simon M, Cox, Edward, Revill, Paul, Musiime, Victor, Bwakura-Dangarembizi, Mutsa, Mallewa, Jane, Cheruiyot, Priscilla, Maitland, Kathryn, Ford, Nathan, Gibb, Diana M., Walker, A. Sarah, and Soares, Marta

Subjects
United Kingdom. Medical Research Council -- Analysis, Bacterial infections -- Analysis -- Health aspects -- Economic aspects, Mortality -- Kenya -- Zimbabwe -- United Kingdom -- Malawi -- Uganda -- Sub-Saharan Africa, Prophylaxis -- Analysis -- Health aspects -- Economic aspects, Highly active antiretroviral therapy -- Economic aspects -- Analysis -- Health aspects, Strategic planning (Business) -- Analysis -- Economic aspects -- Health aspects, Meningitis -- Health aspects -- Analysis -- Economic aspects, HIV -- Health aspects -- Analysis -- Economic aspects, Fluconazole -- Analysis -- Economic aspects -- Health aspects, Antiretroviral agents -- Economic aspects -- Health aspects -- Analysis, Health, World Health Organization
Abstract

Introduction: Many HIV-positive individuals in Africa have advanced disease when initiating antiretroviral therapy (ART) so have high risks of opportunistic infections and death. The REALITY trial found that an enhanced-prophylaxis package including fluconazole reduced mortality by 27% in individuals starting ART with CD4 Methods: The REALITY trial enrolled from June 2013 to April 2015. A decision-analytic model was developed to estimate the cost-effectiveness of six management strategies in individuals initiating ART in the REALITY trial countries. Strategies included standard-prophylaxis, enhanced-prophylaxis, standard-prophylaxis with fluconazole; and three CrAg testing strategies, the first stratifying individuals to enhanced-prophylaxis (CrAg-positive) or standard-prophylaxis (CrAg-negative), the second to enhanced-prophylaxis (CrAg-positive) or enhanced-prophylaxis without fluconazole (CrAg-negative) and the third to standardprophylaxis with fluconazole (CrAg-positive) or without fluconazole (CrAg-negative). The model estimated costs, life-years and quality-adjusted life-years (QALY) over 48 weeks using three competing mortality risks: cryptococcal meningitis; tuberculosis, serious bacterial infection or other known cause; and unknown cause. Results: Enhanced-prophylaxis was cost-effective at cost-effectiveness thresholds of US$300 and US$500 per QALY with an incremental cost-effectiveness ratio (ICER) of US$157 per QALY in the CD4 Conclusions: The REALITY enhanced-prophylaxis package in individuals with advanced HIV starting ART reduces morbidity and mortality, is practical to administer and is cost-effective. Efforts should continue to ensure that components are accessed at lowest available prices. Keywords: HIV; prophylaxis; fluconazole; late-presenters; cost-effectiveness, 1 | INTRODUCTION In low- and middle-income settings, more than a third of HIV-positive individuals starting antiretroviral therapy (ART) present with advanced disease (CD4 [less than or equal to] 200 [...]

Published
2020
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24. Co-trimoxazole or multivitamin multimineral supplement for post-discharge outcomes after severe anaemia in African children: a randomised controlled trial

Author

Maitland, Kathryn, Olupot-Olupot, Peter, Kiguli, Sarah, Chagaluka, George, Alaroker, Florence, Opoka, Robert O, Mpoya, Ayub, Walsh, Kevin, Engoru, Charles, Nteziyaremye, Julius, Mallewa, Machpherson, Kennedy, Neil, Nakuya, Margaret, Namayanja, Cate, Kayaga, Julianne, Nabawanuka, Eva, Sennyondo, Tonny, Aromut, Denis, Kumwenda, Felistas, Musika, Cynthia Williams, Thomason, Margaret J, Bates, Imelda, von Hensbroek, Michael Boele, Evans, Jennifer A, Uyoga, Sophie, Williams, Thomas N, Frost, Gary, George, Elizabeth C, Gibb, Diana M, and Walker, A Sarah

Published
2019
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25. Incidence of switching to second-line antiretroviral therapy and associated factors in children with HIV: an international cohort collaboration

Author

Collins, Intira J, Wools-Kaloustian, Kara, Goodall, Ruth, Smith, Colette, Abrams, Elaine J, Ben-Farhat, Jihane, Balkan, Suna, Davies, Mary-Ann, Edmonds, Andrew, Leroy, Valériane, Nuwagaba-Biribonwoha, Harriet, Patel, Kunjal, Paul, Mary E, Pinto, Jorge, Rojo Conejo, Pablo, Sohn, Annette, Van Dyke, Russell, Vreeman, Rachel, Maxwell, Nicky, Timmerman, Venessa, Duff, Charlotte, Judd, Ali, Seage III, George, Williams, Paige, Gibb, Diana M, Bekker, Linda-Gail, Mofenson, Lynne, Vicari, Marissa, Essajee, Shaffiq, Mohapi, Edith Q, Kazembe, Peter N, Hlatshwayo, Makhosazana, Lumumba, Mwita, Kekitiinwa-Rukyalekere, Adeodata, Wanless, Sebastian, Matshaba, Mogomotsi S., Goetghebuer, Tessa, Thorne, Claire, Warszawski, Josiane, Galli, Luisa, Geelen, Sybil, Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaia, Liubov, Noguera-Julian, Antoni, Naver, Lars, Rudin, Christoph, Jourdain, Gonzague, Volokha, Alla, Rouzier, Vanessa, Succi, Regina, Chokephaibulkit, Kulkanya, Kariminia, Azar, Yotebieng, Marcel, Lelo, Patricia, Lyamuya, Rita, Marete, Irene, Oyaro, Patrick, Boulle, Andrew, Malisita, Kennedy, Fatti, Geoffrey, Haas, Andreas D, Desmonde, Sophie, Dicko, Fatoumata, Abzug, Mark J, Levin, Myron, Oleske, James, Chernoff, Miriam, Traite, Shirley, Purswani, Murli, Teasdale, Chloe, and Chadwick, Ellen

Published
2019
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26. Causes and Timing of Mortality and Morbidity Among Late Presenters Starting Antiretroviral Therapy in the REALITY Trial

Author

Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy (REALITY) Trial Team, Post, Frank A., Szubert, Alexander J., Prendergast, Andrew J., Johnston, Victoria, Lyall, Hermione, Fitzgerald, Felicity, Musiime, Victor, Musoro, Godfrey, Chepkorir, Priscilla, Agutu, Clara, Mallewa, Jane, Rajapakse, Chathurika, Wilkes, Helen, Hakim, James, Mugyenyi, Peter, Walker, A. Sarah, Gibb, Diana M., and Pett, Sarah L.

Published
2018

28. Effect of ready-to-use supplementary food on mortality in severely immunocompromised HIV-infected individuals in Africa initiating antiretroviral therapy (REALITY): an open-label, parallel-group, randomised controlled trial

Author

Mugyenyi, Peter, Kityo, Cissy, Musiime, Victor, Wavamunno, Priscilla, Nambi, Esther, Ocitti, Paul, Ndigendawani, Milly, Kabahenda, Sheila, Kemigisa, Mable, Acen, Juliet, Olebo, David Francis, Mpamize, Gordon, Amone, Alex, Okweny, David, Mbonye, Andrew, Nambaziira, Florence, Rweyora, Angela, Kangah, Mary, Kabaswahili, Beatrice, Abach, James, Abongomera, George, Omongin, Joseph, Aciro, Irene, Philliam, Aleti, Arach, Beatrice, Ocung, Emmanuel, Amone, Geoffrey, Miles, Peter, Adong, Claudia, Tumsuiime, Constance, Kidega, Patrick, Otto, Ben, Apio, Florence, Baleeta, Keith, Mukuye, Andrew, Abwola, Mary, Ssennono, Fred, Baliruno, David, Tuhirwe, Stephen, Namisi, Ronald, Kigongo, Fredrick, Kikyonkyo, Dickson, Mushahara, Furaha, Tusiime, Julian, Musiime, Alex, Nankya, Agnes, Atwongyeire, Dickens, Sirikye, Sowal, Myalo, Sula, Noowe, Nelson, Lugemwa, Abbas, Kasozi, Mariam, Mwebe, Sandra, Atwine, Lorna, Senkindu, Tapson, Natuhurira, Ian, Katemba, Chrispus, Ninsiima, Emily, Acaku, Moses, Kyomuhangi, Joy, Ankunda, Rogers, Tukwasibwe, Deogratious, Ayesiga, Lillian, Hakim, James, Nathoo, Kusum, Bwakura-Dangarembizi, Mutsa, Reid, Andrew, Chidziva, Ennie, Mhute, Tawand, Tinago, Gloria, Bhiri, Joyline, Mudzingwa, Shepherd, Phiri, Misheck, Steamer, John, Nhema, Ruth, Warambwa, Colin, Musoro, Godfrey, Mutsai, Shirley, Nemasango, Beauty, Moyo, Columbus, Chitongo, Stuart, Rashirai, Kennias, Vhembo, Sydney, Mlambo, Brian, Nkomani, Sanele, Ndemera, Buxton, Willard, Marko, Berejena, Chipo, Musodza, Yeukai, Matiza, Patience, Mudenge, Boniface, Guti, Vongai, Etyang, Anthony, Agutu, Clara, Berkley, Jay, Maitland, Kathryn, Njuguna, Patricia, Mwaringa, Shalton, Etyang, Timothy, Awuondo, Ken, Wale, Stephen, Shangala, Jimmy, Kithunga, Jefwa, Mwarumba, Salim, Said Maitha, Salma, Mutai, Robert, Lozi Lewa, Margaret, Mwambingu, Gabriel, Mwanzu, Alfred, Kalama, Connie, Latham, Helen, Shikuku, Joyce, Fondo, Amos, Njogu, Anne, Khadenge, Connie, Mwakisha, Bryan, Siika, Abraham, Wools-Kaloustian, Kara, Nyandiko, Winston, Chepkorir-Cheruiyot, Priscilla, Sudoi, Allan, Wachira, Simon, Meli, Betty, Karoney, Mercy, Nzioka, Agnes, Tanui, Michael, Mokaya, Martha, Ekiru, Wilson, Mboya, Chris, Mwimali, Dorothy, Mengich, Cecilia, Choge, Julie, Injera, Wilfred, Njenga, Kennedy, Cherutich, Salinah, Anyango Orido, Millicent, Omondi Lwande, Gerald, Rutto, Peter, Mudogo, Alice, Kutto, Irene, Shali, Amina, Jaika, Linda, Jerotich, Hellen, Pierre, Mowlem, Mallewa, Jane, Kaunda, Symon, Van Oosterhout, Joep, O'Hare, Bernadette, Heydermann, Robert, Gonzalez, Carmen, Dzabala, Nettie, Kelly, Christine, Denis, Brigitte, Selemani, George, Nyondo- Mipando, Linda, Chirwa, Emmie, Banda, Peter, Mvula, Linley, Msuku, Harrison, Ziwoya, Milton, Manda, Yollam, Nicholas, Simon, Masesa, Clemens, Mwalukomo, Thandi, Makhaza, Lumbani, Sheha, Irene, Bwanali, Joseph, Limbuni, Molly, Gibb, Diana M, Thomason, Margaret J, Walker, Ann Sarah, Pett, Sarah L, Szubert, Alexander J, Griffiths, Anna, Wilkes, Helen, Rajapakse, Chathurika, Spyer, Moira J, Prendergast, Andrew J, Klein, Nigel, Rauchenberger, Mary, Van Looy, Nadine, Little, Emma, Fairbrother, Keith, Cowan, Frances, Seeley, Janet, Bernays, Sarah, Kawuma, Rachel, Mupambireyi, Zivai, Chepkorir, Priscilla, Melly, Betty, Walker, A Sarah, and Berkley, James A

Published
2018
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34. Height and timing of growth spurt during puberty in young people living with vertically acquired HIV in Europe and Thailand

Author

Crichton, Siobhan, Belfrage, Erik, Collins, Intira Jeannie, Doerholt, Katja, Judd, Ali, Le Coeur, Sophie, Spoulou, Vana, Scherpbier, Henriette, Smit, Colette, Goetghebuer, Tessa, Gibb, Diana M., Noguera-Julian, Antoni, Navarro, Maria Luisa, Ramos, Jose Tomas, Galli, Luisa, Giaquinto, Carlo, Thorne, Claire, Ansone, Santa, Marczynska, Magdalena, Okhonskaia, Liubov, Tejada, Begoña Martinez de, Jourdain, Gonzague, Decker, Luc, Ene, Luminita, and Goodall, Ruth

Published
2019
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36. Five year neurodevelopment outcomes of perinatally HIV-infected children on early limited or deferred continuous antiretroviral therapy

Author

Laughton, Barbara, Cornell, Morna, Kidd, Martin, Springer, Priscilla Estelle, Dobbels, Els Francoise Marie-Therese, Van Rensburg, Anita Janse, Otwombe, Kennedy, Babiker, Abdel, Gibb, Diana M., Violari, Avy, Kruger, Mariana, and Cotton, Mark Fredric

Subjects
HIV patients -- Drug therapy -- Analysis, Pediatric research, Pediatric HIV infections -- Drug therapy -- Patient outcomes -- Research, Antiretroviral agents -- Dosage and administration, Central nervous system -- Health aspects -- Research, Health
Abstract

Introduction: Early antiretroviral therapy (ART) has improved neurodevelopmental outcomes of HIV-infected (HIV-positive) children; however, little is known about the longer term outcomes in infants commencing early ART or whether temporary ART interruption might have long-term consequences. In the children with HIV early antiretroviral treatment (CHER) trial, HIV-infected infants [less than or equal to]12 weeks of age with CD4 [greater than or equal to]25% were randomized to deferred ART (ART-Def); immediate time-limited ART for 40 weeks (ART-40W) or 96 weeks (ART-96W). ART was restarted in the time-limited arms for immunologic/clinical progression. Our objective was to compare the neurodevelopmental profiles in all three arms of Cape Town CHER participants. Methods: A prospective, longitudinal observational study was used. The Griffiths mental development scales (GMDS), which includes six subscales and a global score, were performed at 11, 20, 30, 42 and 60 months, and the Beery-Buktenica develop-mental tests for visual motor integration at 60 months. HIV-exposed uninfected (HEU) and HIV-unexposed (HU) children were enrolled for comparison. Mixed model repeated measures were used to compare groups over time, using quotients derived from standardized British norms. Results: In this study, 28 ART-Def, 35 ART-40W, 33 ART-96W CHER children, and 34 HEU and 39 HU controls were enrolled. GMDS scores over five years were similar between the five groups in all subscales except locomotor and general Griffiths (interaction p < 0.001 and p = 0.02 respectively), driven by early lower scores in the ART-Def arm. At 60 months, scores for all groups were similar in each GMDS scale. However, Beery visual perception scores were significantly lower in HIV-infected children (mean standard scores: 75.8 ART-Def, 79.8 ART-40W, 75.9 ART-96W) versus 84.4 in HEU and 90.5 in HU (p < 0.01)). Conclusions: Early locomotor delay in the ART-Def arm resolved by five years. Neurodevelopmental outcomes at five years in HIV-infected children on early time-limited ART were similar to uninfected controls, apart from visual perception where HIV-infected children scored lower. Poorer visual perception performance warrants further investigation. Keywords: HIV care continuum; Children; ARV; CHER trial; Early time-limited antiretroviral therapy; Neurodevelopment; Treatment interruption; Griffiths mental development scales; Visual perception, 1 | INTRODUCTION HIV encephalopathy, a common finding in perinatally HIV-infected children, has decreased since the introduction of combination antiretroviral therapy (ART) [1]. Other neurodevelopmental deficits despite ART remain a [...]

Published
2018
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37. Development of a Pediatric Ebola Predictive Score, Sierra Leone

Author

Fitzgerald, Felicity, Wing, Kevin, Naveed, Asad, Gbessay, Musa, Ross, J.C.G., Checchi, Francesco, Youkee, Daniel, Jalloh, Mohamed Boie, Baion, David E., Mustapha, Ayeshatu, Jah, Hawanatu, Lako, Sandra, Oza, Shefali, Boufkhed, Sabah, Feury, Reynold, Bielicki, Julia, Williamson, Elizabeth, Gibb, Diana M., Klein, Nigel, Sahr, Foday, and Yeung, Shunmay

Subjects
Ebola hemorrhagic fever -- Comparative analysis, Ebola virus -- Comparative analysis, Conjunctivitis -- Comparative analysis, Pediatrics -- Comparative analysis, Virus diseases -- Comparative analysis, Health, World Health Organization
Abstract

The Ebola virus disease (EVD) outbreak in West Africa claimed >11,000 lives with nearly 30,000 cases (l). During the outbreak in Sierra Leone, patients arriving at healthcare facilities were screened [...]

Published
2018
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43. Pharmacokinetic Data of Dolutegravir in Second-line Treatment of Children With Human Immunodeficiency Virus: Results From the CHAPAS4 Trial.

Author

Bevers, Lisanne A H, Waalewijn, Hylke, Szubert, Alexander J, Chabala, Chishala, Bwakura-Dangarembizi, Mutsa, Makumbi, Shafic, Nangiya, Joan, Mumbiro, Vivian, Mulenga, Veronica, Musiime, Victor, Burger, David M, Gibb, Diana M, and Colbers, Angela

Subjects
HIV infections, HIV integrase inhibitors, FOOD consumption, ANTIRETROVIRAL agents, TREATMENT effectiveness, RANDOMIZED controlled trials, DESCRIPTIVE statistics, RESEARCH funding, COMBINED modality therapy, NUCLEOSIDE reverse transcriptase inhibitors, CHILDREN
Abstract

Background Dolutegravir (DTG), combined with a backbone of 2 nucleoside reverse transcriptase inhibitors, is currently the preferred first-line treatment for human immunodeficiency virus (HIV) in childhood. CHAPAS4 is an ongoing randomized controlled trial investigating second-line treatment options for children with HIV. We did a nested pharmacokinetic (PK) substudy within CHAPAS4 to evaluate the DTG exposure in children with HIV taking DTG with food as part of their second-line treatment. Methods Additional consent was required for children on DTG enrolled in the CHAPAS4 trial to participate in this PK substudy. Children weighing 14–19.9 kg took 25 mg DTG as dispersible tablets and children ≥20 kg took 50 mg film-coated tablets. Steady-state 24-hour DTG plasma concentration-time PK profiling was done at t = 0 and 1, 2, 4, 6, 8, 12, and 24 hours after observed DTG intake with food. Reference adult PK data and pediatric data from the ODYSSEY trial were used primarily for comparison. The individual target trough concentration (Ctrough) was defined as 0.32 mg/L. Results Thirty-nine children on DTG were included in this PK substudy. The geometric mean (GM) area under the concentration–time curve over the dosing interval (AUC0-24h) was 57.1 hours × mg/L (coefficient of variation [CV%], 38.4%), which was approximately 8% below the average AUC0-24h in children in the ODYSSEY trial with comparable dosages, but above the adult reference. The GM (CV%) Ctrough was 0.82 mg/L (63.8%), which was comparable to ODYSSEY and adult reference values. Conclusions This nested PK substudy shows that the exposure of DTG taken with food in children on second-line treatment is comparable with that of children in the ODYSSEY trial and adult references. Clinical Trials Registration. ISRCTN22964075. [ABSTRACT FROM AUTHOR]

Published
2023
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44. First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.

Author

Waalewijn, Hylke, Szubert, Alexander J, Wasmann, Roeland E, Wiesner, Lubbe, Chabala, Chishala, Bwakura-Dangarembizi, Mutsa, Makumbi, Shafic, Nangiya, Joan, Mumbiro, Vivian, Mulenga, Veronica, Musiime, Victor, Monkiewicz, Lara N, Griffiths, Anna L, Bamford, Alasdair, Doerholt, Katja, Denti, Paolo, Burger, David M, Gibb, Diana M, McIlleron, Helen M, and Colbers, Angela

Subjects
HIV infections, REFERENCE values, HIV integrase inhibitors, PROTEASE inhibitors, COMBINATION drug therapy, TENOFOVIR, RESEARCH funding
Abstract

Background We evaluated the pharmacokinetics of tenofovir alafenamide fumarate (TAF) and tenofovir in a subset of African children enrolled in the CHAPAS-4 trial. Methods Children aged 3–15 years with human immunodeficiency virus infection failing first-line antiretroviral therapy were randomized to emtricitabine/TAF versus standard-of-care nucleoside reverse transcriptase inhibitor combination, plus dolutegravir, atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. Daily emtricitabine/TAF was dosed according to World Health Organization (WHO)–recommended weight bands: 120/15 mg in children weighing 14 to <25 kg and 200/25 mg in those weighing ≥25 kg. At steady state, 8–9 blood samples were taken to construct pharmacokinetic curves. Geometric mean (GM) area under the concentration–time curve (AUC) and the maximum concentration (Cmax) were calculated for TAF and tenofovir and compared to reference exposures in adults. Results Pharmacokinetic results from 104 children taking TAF were analyzed. GM (coefficient of variation [CV%]) TAF AUClast when combined with dolutegravir (n = 18), darunavir/ritonavir (n = 34), or lopinavir/ritonavir (n = 20) were 284.5 (79), 232.0 (61), and 210.2 (98) ng*hour/mL, respectively, and were comparable to adult reference values. When combined with atazanavir/ritonavir (n = 32), TAF AUClast increased to 511.4 (68) ng*hour/mL. For each combination, tenofovir GM (CV%) AUCtau and Cmax remained below reference values in adults taking 25 mg TAF with a boosted protease inhibitors. Conclusions In children, TAF combined with boosted PIs or dolutegravir and dosed according to WHO-recommended weight bands provides TAF and tenofovir concentrations previously demonstrated to be well tolerated and effective in adults. These data provide the first evidence for use of these combinations in African children. Clinical Trials Registration ISRCTN22964075. [ABSTRACT FROM AUTHOR]

Published
2023
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45. Levofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)

Author

Seddon, James A., Garcia-Prats, Anthony J., Purchase, Susan E., Osman, Muhammad, Demers, Anne-Marie, Hoddinott, Graeme, Crook, Angela M., Owen-Powell, Ellen, Thomason, Margaret J., Turkova, Anna, Gibb, Diana M., Fairlie, Lee, Martinson, Neil, Schaaf, H. Simon, and Hesseling, Anneke C.

Published
2018
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46. Growing up with perinatal HIV: changes in clinical outcomes before and after transfer to adult care in the UK

Author

Judd, Ali, Collins, Intira Jeannie, Parrott, Francesca, Hill, Teresa, Jose, Sophie, Ford, Deborah, Asad, Hibo, Gibb, Diana M., and Sabin, Caroline

Subjects
HIV (Viruses) -- Care and treatment -- Analysis, Mortality -- United Kingdom -- Analysis, Medical care -- United Kingdom -- Management -- Analysis, Company business management, Health
Abstract

Abstract Introduction: With improved survival, adolescents with perinatal HIV (PHIV) are transitioning from paediatric to adult care, but there are few published data on clinical outcomes post-transfer. Using linked data [...]

Published
2017
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47. Outcomes of second‐line antiretroviral therapy among children living with HIV: a global cohort analysis

Author

Patel, Kunjal, Smith, Colette, Collins, Intira Jeannie, Goodall, Ruth, Abrams, Elaine J., Sohn, Annette H., Mohamed, Thahira J., Van Dyke, Russell B., Rojo, Pablo, Wools?Kaloustian, Kara, Pinto, Jorge, Edmonds, Andrew, Marete, Irene, Paul, Mary, Nuwaqaba?Biribonwoha, Harriet, Leroy, Valériane, Davies, Mary?Ann, Vreeman, Rachel, Maxwell, Nicky, Timmerman, Venessa, Duff, Charlotte, Mofenson, Lynne, Bekker, Linda?Gail, Vicari, Marissa, Essajee, Shaffiq, Penazzato, Martina, Slogrove, Amy, Williams, Paige, Crichton, Siobhan, Seage, George, Thahane, Lineo, Kazembe, Peter N., Lukhele, Bhekumusa, Mwita, Lumumba, Kekitiinwa?Rukyalekere, Adeodata, Wanless, Sebastian, Matshaba, Mogomotsi S., Goetghebuer, Tessa, Thorne, Claire, Warszawski, Josiane, Galli, Luisa, Geelen, Sybil, Gibb, Diana M., Giaquinto, Carlo, Marczynska, Magdalena, Marques, Laura, Prata, Filipa, Ene, Luminita, Okhonskaia, Liubov, Noguera?Julian, Antoni, Naver, Lars, Rudin, Christoph, Jourdain, Gonzague, Judd, Ali, Volokha, Alla, Rouzier, Vanessa, Succi, Regina, Kariminia, Azar, Yotebieng, Marcel, Lelo, Patricia, Lyamuya, Rita, Oyaro, Patrick, Boulle, Andrew, Malisita, Kennedy, Fatti, Geoffrey, Haas, Andreas D., Desmonde, Sophie, Dicko, Fatoumata, Abzug, Mark J., Purswani, Murli, Van Dyke, Russell, Chadwick, Ellen, Abrams, Elaine, Teasdale, Chloe, and Nuwagaba, Harriet

Subjects
HIV infection in children -- Statistics -- Drug therapy -- Patient outcomes, Highly active antiretroviral therapy -- Patient outcomes -- Statistics, Pediatric research, Health
Abstract

: Introduction: Limited data describe outcomes on second‐line antiretroviral therapy (ART) among children globally. Our objective was to contribute data on outcomes among children living with HIV after initiation of second‐line ART in the context of routine care within a large global cohort collaboration. Methods: Patient‐level data from 1993 through 2015 from 11 paediatric HIV cohorts were pooled. Characteristics at switch and through two years of follow‐up were summarized for children who switched to second‐line ART after starting a standard first‐line regimen in North America, Latin America, Europe, Asia, Southern Africa (South Africa & Botswana) and the rest of sub‐Saharan Africa (SSA). Cumulative incidences of mortality and loss to follow‐up (LTFU) were estimated using a competing risks framework. Results: Of the 85,389 children on first‐line ART, 3,555 (4%) switched to second‐line after a median of 2.8 years on ART (IQR: 1.6, 4.7); 69% were from Southern Africa or SSA and 86% of second‐line regimens were protease inhibitor‐based. At switch, median age was 8.4 years and 50% had a prior AIDS diagnosis. Median follow‐up after switch to second‐line ranged from 1.8 years in SSA to 5.3 years in North America. Median CD4 counts at switch to second‐line ranged from 235 cells/mm[sup.3] in SSA to 828 cells/mm[sup.3] in North America. Improvements in CD4 counts were observed over two years of follow‐up, particularly in regions with lower CD4 counts at second‐line switch. Improvements in weight‐for‐age z‐scores were not observed during follow‐up. Cumulative incidence of LTFU at two years was Conclusions: Children switched to second‐line ART experience CD4 count increases as well as low to moderate rates of LTFU and mortality within two years after switch. Severe immune deficiency at time of switch in some settings suggests need for improved recognition and management of treatment failure in children., Introduction In 2018, there were an estimated 1.7 million children living with HIV globally and 160,000 new paediatric infections [1]. With the recommendation for immediate antiretroviral therapy (ART) [2], substantial [...]

Published
2020
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49. Authors’ reply to Southall

Author

Kiguli, Sarah, Akech, Samuel O, Mtove, George, Opoka, Robert O, Engoru, Charles, Olupot-Olupot, Peter, Nyeko, Richard, Evans, Jennifer, Crawley, Jane, Prevatt, Natalie, Reyburn, Hugh, Levin, Michael, George, Elizabeth C, South, Annabelle, Babiker, Abdel G, Gibb, Diana M, and Maitland, Kathryn

Published
2014

50. WHO guidelines on fluid resuscitation in children : missing the FEAST data

Author

Kiguli, Sarah, Akech, Samuel O, Mtove, George, Opoka, Robert O, Engoru, Charles, Olupot-Olupot, Peter, Nyeko, Richard, Evans, Jennifer, Crawley, Jane, Prevatt, Natalie, Reyburn, Hugh, Levin, Michael, George, Elizabeth C, South, Annabelle, Babiker, Abdel G, Gibb, Diana M, and Maitland, Kathryn

Published
2014

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