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1. Twice-Daily Dosing of Dolutegravir in Infants on Rifampicin Treatment: A Pharmacokinetic Substudy of the EMPIRICAL Trial.

Author

Jacobs, Tom, Mumbiro, Vivian, Cassia, Uneisse, Zimba, Kevin, Nalwanga, Damalie, Ballesteros, Alvaro, Domínguez-Rodríguez, Sara, Tagarro, Alfredo, Madrid, Lola, Mutata, Constantine, Chitsamatanga, Moses, Bwakura-Dangarembizi, Mutsa, Passanduca, Alfeu, Buck, W, Nduna, Bwendo, Chabala, Chishala, Najjingo, Elizabeth, Musiime, Victor, Moraleda, Cinta, Colbers, Angela, Mujuru, Hilda, Rojo, Pablo, and Burger, David

Subjects
HIV, dolutegravir, drug–drug interaction, infants, rifampicin, Female, Humans, Infant, Male, Heterocyclic Compounds, 3-Ring, HIV, HIV Infections, Oxazines, Piperazines, Pyridones, Rifampin
Abstract

BACKGROUND: We evaluated dolutegravir pharmacokinetics in infants with human immunodeficiency virus (HIV) receiving dolutegravir twice daily (BID) with rifampicin-based tuberculosis (TB) treatment compared with once daily (OD) without rifampicin. METHODS: Infants with HIV aged 1-12 months, weighing ≥3 kg, and receiving dolutegravir BID with rifampicin or OD without rifampicin were eligible. Six blood samples were taken over 12 (BID) or 24 hours (OD). Dolutegravir pharmacokinetic parameters, HIV viral load (VL) data, and adverse events (AEs) were reported. RESULTS: Twenty-seven of 30 enrolled infants had evaluable pharmacokinetic curves. The median (interquartile range) age was 7.1 months (6.1-9.9), weight was 6.3 kg (5.6-7.2), 21 (78%) received rifampicin, and 11 (41%) were female. Geometric mean ratios comparing dolutegravir BID with rifampicin versus OD without rifampicin were area under curve (AUC)0-24h 0.91 (95% confidence interval, .59-1.42), Ctrough 0.95 (0.57-1.59), Cmax 0.87 (0.57-1.33). One infant (5%) receiving rifampicin versus none without rifampicin had dolutegravir Ctrough

Published
2024

3. First-Line Antituberculosis Drug Concentrations in Infants With HIV and a History of Recent Admission With Severe Pneumonia.

Author

Chabala, Chishala, Jacobs, Tom, Moraleda, Cinta, Ndaferankhande, John, Mumbiro, Vivian, Passanduca, Alfeu, Namuziya, Natasha, Nalwanga, Damalie, Musiime, Victor, Ballesteros, Alvaro, Domínguez-Rodríguez, Sara, Chitsamatanga, Moses, Cassia, Uneisse, Nduna, Bwendo, Bramugy, Justina, Sacarlal, Jahit, Madrid, Lola, Nathoo, Kusum, Colbers, Angela, Burger, David, Mulenga, Veronica, Buck, William, Mujuru, Hilda, Te Brake, Lindsey, Rojo, Pablo, Tagarro, Alfredo, and Aarnoutse, Rob

Subjects
HIV, HRZE, Tuberculosis, infants, pharmacokinetics, Adult, Infant, Humans, Antitubercular Agents, HIV Infections, Pneumonia, Reference Values
Abstract

Optimal antituberculosis therapy is essential for favorable clinical outcomes. Peak plasma concentrations of first-line antituberculosis drugs in infants with living HIV receiving WHO-recommended dosing were low compared with reference values for adults, supporting studies on increased doses of first-line TB drugs in infants.

Published
2023

7. Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial

Author

Rojo, Pablo, Moraleda, Cinta, Tagarro, Alfredo, Domínguez-Rodríguez, Sara, Castillo, Lola Madrid, Tato, Luis Manuel Prieto, López, Aranzazu Sancho, Manukyan, Lilit, Marcy, Olivier, Leroy, Valeriane, Nardone, Alessandra, Burger, David, Bassat, Quique, Bates, Matthew, Moh, Raoul, Iroh Tam, Pui-Ying, Mvalo, Tisungane, Magallhaes, Justina, Buck, W Chris, Sacarlal, Jahit, Musiime, Victor, Chabala, Chishala, and Mujuru, Hilda Angela

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Rare Diseases, Pneumonia, Clinical Trials and Supportive Activities, Tuberculosis, Pediatric, Patient Safety, HIV/AIDS, Clinical Research, Pneumonia & Influenza, Lung, Orphan Drug, Infectious Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Child, Clinical Trials, Phase II as Topic, Cytomegalovirus, Cytomegalovirus Infections, HIV Infections, Humans, Infant, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Treatment Outcome, Valganciclovir, Factorial, Empirical, HIV, Infants, Child mortality, Factorial randomized clinical trial, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine, Clinical sciences, Epidemiology, Health services and systems
Abstract

BackgroundPneumonia is the primary cause of death among HIV-infected children in Africa, with mortality rates as high as 35-40% in infants hospitalized with severe pneumonia. Bacterial pathogens and Pneumocystis jirovecii are well known causes of pneumonia-related death, but other important causes such as cytomegalovirus (CMV) and tuberculosis (TB) remain under-recognized and undertreated. The immune response elicited by CMV may be associated with the risk of developing TB and TB disease progression, and CMV may accelerate disease caused both by HIV and TB. Minimally invasive autopsies confirm that CMV and TB are unrecognized causes of death in children with HIV. CMV and TB may also co-infect the same child. The aim of this study is to compare the impact on 15-day and 1-year mortality of empirical treatment against TB and CMV plus standard of care (SoC) versus SoC in HIV-infected infants with severe pneumonia.MethodsThis is a Phase II-III, open-label randomized factorial (2 × 2) clinical trial, conducted in six African countries. The trial has four arms. Infants from 28 to 365 days of age HIV-infected and hospitalized with severe pneumonia will be randomized (1:1:1:1) to (i) SoC, (ii) valganciclovir, (iii) TB-T, and (iv) TB-T plus valganciclovir. The primary endpoint of the study is all-cause mortality, focusing on the short-term (up to 15 days) and long-term (up to 1 year) mortality. Secondary endpoints include repeat hospitalization, duration of oxygen therapy during initial admission, severe and notable adverse events, adverse reactions, CMV and TB prevalence at enrolment, TB incidence, CMV viral load reduction, and evaluation of diagnostic tests such as GeneXpert Ultra on fecal and nasopharyngeal aspirate samples and urine TB-LAM.DiscussionGiven the challenges in diagnosing CMV and TB in children and results from previous autopsy studies that show high rates of poly-infection in HIV-infected infants with respiratory disease, this study aims to evaluate a new approach including empirical treatment of CMV and TB for this patient population. The potential downsides of empirical treatment of these conditions include toxicity and medication interactions, which will be evaluated with pharmacokinetics sub-studies.Trial registrationClinicalTrials.gov , NCT03915366, Universal Trial Number U111-1231-4736, Pan African Clinical Trial Registry PACTR201994797961340.

Published
2022

12. 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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13. Pharmacokinetics of antiretroviral and tuberculosis drugs in children with HIV/TB co-infection: a systematic review

Author

Jacobs, Tom G, Svensson, Elin M, Musiime, Victor, Rojo, Pablo, Dooley, Kelly E, McIlleron, Helen, Aarnoutse, Rob E, Burger, David M, Turkova, Anna, Colbers, Angela, Abrams, Elaine, Archary, Moherndran, Belew, Yodit, Best, Brookie, Burger, David, Burry, Jessica, Capparelli, Edmund, Carpenter, Deborah, Casas, Esther, Clayden, Polly, Clarke, Diana, Cressey, Tim, Dangarembizi, Mutsa, Denti, Paolo, Diop, Karim, Ecker, Andrea, Essajee, Shaffiq, Giaquinto, Carlo, Gibb, Diana, Hazra, Rohan, Kim, Maria, Lallemant, Marc, Lee, Janice, Lewis, Linda, Lockman, Shahin, Mirochnick, Mark, Mofenson, Lynne, Obimbo, Elizabeth, Ojoo, Atieno, Pascual, Fernando, Penazzato, Martina, Pinto, Jorge, Rakhmanina, Natella, Ruel, Ted, Siberry, George, Sugandhi, Nandita, Vicari, Marissa, Watkins, Melynda, and Wolf, Hilary

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Rare Diseases, HIV/AIDS, Infectious Diseases, Tuberculosis, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Anti-HIV Agents, Child, Child, Preschool, Coinfection, HIV Infections, Humans, Lopinavir, Pharmaceutical Preparations, WHO Paediatric Antiretroviral Working Group, Microbiology, Pharmacology and Pharmaceutical Sciences, Clinical sciences, Pharmacology and pharmaceutical sciences
Abstract

IntroductionManagement of concomitant use of ART and TB drugs is difficult because of the many drug-drug interactions (DDIs) between the medications. This systematic review provides an overview of the current state of knowledge about the pharmacokinetics (PK) of ART and TB treatment in children with HIV/TB co-infection, and identifies knowledge gaps.MethodsWe searched Embase and PubMed, and systematically searched abstract books of relevant conferences, following PRISMA guidelines. Studies not reporting PK parameters, investigating medicines that are not available any longer or not including children with HIV/TB co-infection were excluded. All studies were assessed for quality.ResultsIn total, 47 studies met the inclusion criteria. No dose adjustments are necessary for efavirenz during concomitant first-line TB treatment use, but intersubject PK variability was high, especially in children 4 weeks old as well as twice-daily dolutegravir (instead of once daily) in children older than 6 years. Exposure to some TB drugs (ethambutol and rifampicin) was reduced in the setting of HIV infection, regardless of ART use. Only limited PK data of second-line TB drugs with ART in children who are HIV infected have been published.ConclusionsWhereas integrase inhibitors seem favourable in older children, there are limited options for ART in young children (

Published
2020

14. 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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16. 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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17. Prioritising the most needed paediatric antiretroviral formulations: the PADO4 list.

Author

Penazzato, Martina, Townsend, Claire L, Rakhmanina, Natella, Cheng, Yao, Archary, Moherndran, Cressey, Tim R, Kim, Maria H, Musiime, Victor, Turkova, Anna, Ruel, Theodore D, Rabie, Helena, Sugandhi, Nandita, Rojo, Pablo, Doherty, Meg, Abrams, Elaine J, and PADO4 participants

Subjects
PADO4 participants, Humans, HIV Infections, Anti-HIV Agents, Drug Compounding, Lactation, Pregnancy, Developing Countries, Adolescent, Child, Infant, Infant, Newborn, Female, Congresses as Topic, Pediatric, Infectious Diseases, HIV/AIDS, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Medical and Health Sciences
Abstract

Despite considerable progress in paediatric HIV treatment and timely revision of global policies recommending the use of more effective and tolerable antiretroviral regimens, optimal antiretroviral formulations for infants, children, and adolescents remain limited. The Paediatric Antiretroviral Drug Optimization group reviews medium-term and long-term priorities for antiretroviral drug development to guide industry and other stakeholders on formulations most needed for low-income and middle-income countries. The group convened in December, 2018, to assess progress since the previous meeting and update the list of priority formulations. Issues relating to drug optimisation for neonatal prophylaxis and paediatric treatment, and those relating to the investigation of novel antiretrovirals in adolescents and pregnant and lactating women were also discussed. Continued focus on identifying, prioritising, and providing access to optimal antiretroviral formulations suitable for infants, children, and adolescents is key to ensuring that global HIV treatment targets can be met.

Published
2019

19. 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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20. 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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21. What babies need: accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies

Author

Burger, David, Bekker, Adrie, Cressey, Tim, Hirt, Deborah, Lutsar, Irja, Mcilleron, Helen, Standing, Joe, Van den Anker, John, Svensson, Elin, Abrams, Elaine, Amuge, Pauline, Archary, Mo, Belew, Yodit, Best, Brookie, Bygrave, Helen, Capparelli, Edmund, Casas, Esther, Clarke, Diana, Clayden, Polly, Colbers, Angela, Dangarembizi, Mutsa, De Lisa, Roberto, Denti, Paolo, Domanico, Paul, Essajee, Shaffiq, Frigati, Lisa, Giaquinto, Carlo, Gibb, Diana, Hackett, Stephanie, Hazra, Rohan, Lallemant, Marc, Lewis, Linda, Lockman, Shahin, Mahaka, Imelda, McFarland, Betsy, Meere, Cathal, Mir, Fatima, Mirochnick, Mark, Mofenson, Lynne, Mukui, Irene, Mushavi, Angela, Musiime, Victor, Namusoke-Magongo, Eleanor, Obimbo, Elisabeth, Ojoo, Mary Atieno, Parades, Roger, Perez-Casas, Carmen, Piccolis, Manuele, Pinto, Jorge, Puthanakit, Thanyawee, Rakhmanina, Natella, Reinisch, Annette, Rojo, Pablo, Rouzier, Vanessa, Ruel, Ted, Sam-Agudu, Nadia, Siberry, George, Simione, Teresa, Simon, Katie, Singh, Vindi, Solares, Manjari, Sugandhi, Nandita, Sylla, Mariam, Thior, Ibou, Turkova, Anna, Vicari, Marissa, Walsh, Jenny, Watkins, Melynda, Wolf, Hilary, Hafiz, Asma, Penazzato, Martina, Rangaraj, Ajay, Doherty, Meg, Vitoria, Marco, Jacobs, Tom G, Schouwenburg, Stef, Archary, Moherndran, Ruel, Theodore D, van den Anker, John, Burger, David M, Cressey, Tim R, Abrams, Elaine J, and Lyall, Hermione

Published
2022
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24. 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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25. Pharmacokinetics of once-daily darunavir/ritonavir in second-line treatment in African children with HIV.

Author

Tsirizani, Lufina, Naghani, Shaghayegh Mohsenian, Waalewijn, Hylke, Szubert, Alexander, Mulenga, Veronica, Chabala, Chishala, Bwakura-Dangarembizi, Mutsa, Chitsamatanga, Moses, Rutebarika, Diana A, Musiime, Victor, Kasozi, Mariam, Lugemwa, Abbas, Monkiewicz, Lara N, McIlleron, Helen M, Burger, David M, Gibb, Diana M, Denti, Paolo, Wasmann, Roeland E, and Colbers, Angela

Subjects
HIV protease inhibitors, HIV-positive children, DARUNAVIR, RITONAVIR, TENOFOVIR, LAMIVUDINE
Abstract

Background Darunavir is a potent HIV protease inhibitor with a high barrier to resistance. We conducted a nested pharmacokinetic sub-study within CHAPAS-4 to evaluate darunavir exposure in African children with HIV, taking once-daily darunavir/ritonavir for second-line treatment. Methods We used data from the CHAPAS-4 pharmacokinetic sub-study treating children with once-daily darunavir/ritonavir (600/100 mg if 14–24.9 kg and 800/100 mg if ≥25 kg) with either tenofovir alafenamide fumarate (TAF)/emtricitabine (FTC), abacavir/lamivudine or zidovudine/lamivudine. Steady-state pharmacokinetic sampling was done at 0, 1, 2, 4, 6, 8, 12 and 24 hours after observed darunavir/ritonavir intake. Non-compartmental and population pharmacokinetic analyses were used to describe the data and identify significant covariates. Reference adult pharmacokinetic data were used for comparison. We simulated the World Health Organization (WHO) recommended 600/100 mg darunavir/ritonavir dose for the 25–34.9 kg weight band. Results Data from 59 children with median age and weight 10.9 (range 3.8–14.7) years and 26.0 (14.5–47.0) kg, respectively, were available. A two-compartment disposition model with transit absorption compartments and weight-based allometric scaling of clearance and volume best described darunavir data. Our population achieved geometric mean (%CV) darunavir AUC0–24h, 94.3(50) mg·h/L and C max, 9.1(35) mg/L, above adult reference values and C trough, 1.5(111) mg/L, like adult values. The nucleoside reverse-transcriptase inhibitor backbone was not found to affect darunavir concentrations. Simulated WHO-recommended darunavir/ritonavir doses showed exposures equivalent to adults. Higher alpha-1-acid glycoprotein increased binding to darunavir and decreased apparent clearance of darunavir. Conclusions Darunavir exposures achieved in our trial are within safe range. Darunavir/ritonavir can safely be co-administered with TAF/FTC. Both WHO-recommended 600/100 mg and CHAPAS-4 800/100 mg darunavir/ritonavir doses for the 25–34.9 kg weight band offer favourable exposures. The choice between them can depend on tablet availability. [ABSTRACT FROM AUTHOR]

Published
2024
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27. High Incidence of Refeeding Syndrome during the Transition from F75 to Ready‐to‐Use Therapeutic Feeds among Children 6 to 59 Months with Severe Acute Malnutrition at the Pediatric Nutritional Unit of Mulago Hospital.

Author

Muzeyi, Wani, Ochieng Andra, Teddy, Oriokot, Lorraine, Musiime, Victor, and Bhaswant, Maharshi

Abstract

Background. Refeeding syndrome is a complication developed by children being managed for severe acute malnutrition (SAM). It is caused by changes in electrolyte balance once high‐caloric feeding is reinitiated. Phosphorus, potassium, and magnesium are the main electrolytes affected when it occurs. However, hypophosphatemia is the hallmark of the diagnosis of refeeding syndrome. WHO recommends inpatient management of patients with complicated SAM with initially F75 which is low in calories and later transitioned to RUTF which is high in calories but also has a higher phosphorus content. Objective. This study aims to determine the incidence and factors associated with refeeding syndrome in the transition phase when treating children aged 6 to 59 months with severe acute malnutrition at the Mwanamugimu Nutritional Unit, Mulago. Methods. We conducted a prospective cohort study at the Mwanamugimu Nutritional Unit of Mulago National Referral Hospital. A total of 150 children between 6 and 59 months with SAM were enrolled into the study. We measured serum electrolytes (phosphorus, sodium, and potassium) at admission, initiation of RUTF, and 48 hours after transition. The refeeding syndrome was diagnosed by a drop in serum phosphorus of more than 0.3 mmol from baseline. The data were analyzed using STATA 17.0. Incidence of refeeding syndrome was determined as the proportion of participants whose serum phosphorus declined by more than 0.3 mmol from baseline. For factors associated, a multivariate‐modified Poisson regression analysis reporting relative risk was performed with a 0.2 level of significance at bivariate and 0.05 at multivariate analyses. Results. Of the 150 children recruited, 35 were lost to follow‐up and 115 children had their data analyzed. Of the 115 participants in the study, 40 developed refeeding syndrome indicating a cumulative incidence of 34.8% with a 95% CI of 26.5–44%. A low baseline serum sodium (RR: 0.89, 95% CI: 0.80–0.99, and P value: 0.038) and having edematous malnutrition (RR: 0.90, 95% CI: 0.81–0.99, and P value; 0.042) at admission were found to be significant (P < 0.05) risk factors of refeeding syndrome. Conclusion. The cumulative incidence of RFS of 34.8% is very high. RFS is found to be associated with low baseline sodium and pedal edema. Children with a low baseline sodium and edema should undergo a cautious transition of feeds. [ABSTRACT FROM AUTHOR]

Published
2024
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28. HIV prevalence among children admitted with severe acute malnutrition and associated factors with mother-to-child HIV transmission at Mulago Hospital, Uganda: A mixed methods study

Author

Musiime, Victor, primary, Rujumba, Joseph, additional, Kakooza, Lawrence, additional, Namisanvu, Henriator, additional, Atuhaire, Loice, additional, Naguti, Erusa, additional, Beinomugisha, Judith, additional, Kiggwe, Andrew, additional, Nkinzi, Sharafat, additional, Segawa, Ivan, additional, Matsiko, Nicholas, additional, Babirekere-Iriso, Esther, additional, and Musoke, Philippa, additional

Published
2024
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32. PA-655 Severe pneumonia is associated with worse neurocognitive function among infants living with HIV

Author

Nalwanga, Damalie, primary, Moraleda, Cinta, additional, Tagoola, Abner, additional, Lubega, John Paul, additional, Nalunkuma, Amina, additional, Kakooza, Lawrence, additional, Kiggwe, Andrew, additional, Mbabazi, Bashira, additional, Nkinzi, Sharafat, additional, Ballesteros, Alvaro, additional, Tagarro, Alfredo, additional, Rojo, Pablo, additional, and Musiime, Victor, additional

Published
2023
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33. OA-429 High mortality in African infants living with HIV hospitalized with severe pneumonia

Author

Nduna, Bwendo, primary, Moraleda, Cinta, additional, Sacaral, Jahit, additional, Beinomugisha, Judith, additional, Zulu, Idah, additional, Chitamatanga, Moses, additional, Tam, Pui-Ying Iroh, additional, Chawinga, Chimwemwe, additional, Fernandez, Sheila, additional, Ballesteros, Álvaro, additional, Passanduca, Alfeu, additional, Tagoola, Abner, additional, Atibo, Raul, additional, Nansera, Denis, additional, Bwakura-Dangarembizi, Mutsa, additional, Gambi, Lughano, additional, Mvalo, Tisungane, additional, Madrid, Lola, additional, Macmillan, Belinda, additional, Musiime, Victor, additional, Moh, Raoul, additional, Buck, Chris W, additional, Chabala, Chishala, additional, Tagarro, Alfredo, additional, Rojo, Pablo, additional, and Empirical, Trial, additional

Published
2023
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34. PA-675 Navigating the COVID-19 pandemic for participant recruitment and follow-up: experiences from the PediCAP clinical trial consortium

Author

Kiggwe, Andrew, primary, Nalwanga, Damalie, additional, Tagoola, Abner, additional, Madhi, Shabir, additional, Moore, David, additional, Archary, Moherndran Archary, additional, Mulenga, Veronica, additional, Mujuru, Hilda Angela, additional, Sacarlal, Jahit, additional, Buck, Chris, additional, Sidat, Muhammad, additional, Nguyen, Hanh, additional, Haque, Farjana, additional, Dennis, Emily, additional, Clements, Michelle, additional, Murphy, Brendan, additional, Spittle, Ben, additional, Viero, Francesca, additional, Bielick, Julia, additional, Musiime, Victor, additional, and Sharland, Mike, additional

Published
2023
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35. OA-286 Plasma concentrations of first line antituberculosis drugs in infants with HIV and severe pneumonia: a pharmacokinetic sub-study of the empirical trial

Author

Chabala, Chishala, primary, Jacobs, Tom, additional, Moraleda, Cinta, additional, Mumbiro, Vivian, additional, Namuziya, Natasha, additional, Mutesi, Sophie, additional, Domínguez-Rodríguez, Sara, additional, Chitsamatanga, Moses, additional, Casia, Uneisse, additional, Nalwanga, Damalie, additional, Nduna, Bwendo, additional, Lajara, Nancy, additional, Ballesteros, Alvaro, additional, Madrid, Lola, additional, Nathoo, Kusum, additional, Mulenga, Veronica, additional, Buck, Chris, additional, Musiime, Victor, additional, Mujuru, Hilda, additional, Tagarro, Alfredo, additional, Brake, Lindsey te, additional, Aarnoutse, Rob, additional, Rojo, Pablo, additional, and Burger, David, additional

Published
2023
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39. 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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40. Prioritising the most needed paediatric antiretroviral formulations: the PADO4 list

Author

Abrams, Elaine, Ananworanich, Jintanat, Andrieux-Meyer, Isabelle, Archary, Moherndran, Belew, Yodit, Best, Brookie, Bologna, Rosa, Burry, Jessica, Carpenter, Deborah, Cheng, Yao, Clayden, Polly, Colbers, Angela, Conway, Magda, Cressey, Timothy R., Dangarembizi, Mutsa, Essajee, Shaffiq, Gonzalez Tome, Maribel, Hill, Andrew, Khoo, Saye, Kim, Maria, Lewis, Linda, Lee, Janice, Lockman, Shahin, Mahaka, Imelda, Mirochnick, Mark H., Mofenson, Lynne, Muhimpundu, Mireille, Mushavi, Angela, Musiime, Victor, Obimbo, Elizabeth, Pascual, Fernando, Perez Casas, Carmen, Pozniak, Anton, Rabie, Helena, Rakhmanina, Natella, Rojo, Pablo, Ruel, Theodore, Schapiro, Jonathan, Siberry, George, Simione, Teresa Beatriz, Sugandhi, Nandita, Tidiane Tall, Cheick, Turkova, Anna, Venter, Francois, Vicari, Marissa, Walsh, Jenny, Wambui, Jacque, Watkins, Melynda, Penazzato, Martina, Townsend, Claire L, Cressey, Tim R, Kim, Maria H, Ruel, Theodore D, Doherty, Meg, and Abrams, Elaine J

Published
2019
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41. Impact of COVID-19 on Well-Being and Physical Activity in Ugandan Children With and Without HIV.

Author

Milad, Mina, Karungi, Christine, Sattar, Abdus, Musiime, Victor, Nazzinda, Rashidah, McComsey, Grace A., and Dirajlal-Fargo, Sahera

Subjects
PHYSICAL activity, WELL-being, COVID-19 pandemic, COVID-19, CHILDHOOD obesity
Abstract

Background: The present study aims to understand the socioeconomic and physical activity impact of the COVID-19 pandemic on children living with perinatally acquired HIV (PHIV) and without HIV (HIV−) in Kampala (Uganda). Methods: The authors included children aged 10–18 years who filled out questionnaires at baseline (2017–2018, prepandemic) and 2 years later (March 2020–January 2021, pandemic) in an observational cohort study at Joint Clinical Research Centre (Kampala). Physical activity energy expenditure was calculated using a youth compendium from the National Collaborative on Childhood Obesity Research. Descriptive and standard test statistics including Kruskal–Wallis were used. Results: One hundred and ninety-eight children from Kampala Uganda were included prepandemic (101 PHIV and 97 HIV−); 131 (71 PHIV and 60 HIV−) had information collected during the pandemic. At baseline, median and interquartile range age was 13 years (11; 15), and 52% were females. During the pandemic, overall weekly physical activity increased by a median of 854 minutes (interquartile range: 270–1890), and energy expenditures increased by 16% in both PHIV and in HIV− (P <.001 for groups overall prepandemic vs pandemic). Conclusions: The authors found in this Ugandan cohort of children that children engaged in more physical activity. Further research is warranted to understand the long-term effects of the pandemic on children's well-being. [ABSTRACT FROM AUTHOR]

Published
2022
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42. Population Pharmacokinetics of Pediatric Lopinavir/Ritonavir Oral Pellets in Children Living with HIV in Africa.

Author

Chupradit, Suthunya, Wamalwa, Dalton C., Maleche‐Obimbo, Elizabeth, Kekitiinwa, Adeodata R., Mwanga‐Amumpaire, Juliet, Bukusi, Elizabeth A., Nyandiko, Winstone M., Mbuthia, Joseph K., Swanson, Alistair, Cressey, Tim R., Punyawudho, Baralee, and Musiime, Victor

Subjects
HIV-positive children, RITONAVIR, COLD storage, ANTIRETROVIRAL agents
Abstract

Antiretroviral therapy for children living with HIV (CLHIV) under 3 years of age commonly includes lopinavir/ritonavir (LPV/r). However, the original liquid LPV/r formulation has taste and cold storage difficulties. To address these challenges, LPV/r oral pellets have been developed. These pellets can be mixed with milk or food for administration and do not require refrigeration. We developed the population pharmacokinetic (PK) model and assessed drug exposure of LPV/r oral pellets administered twice daily to CLHIV per World Health Organization (WHO) weight bands. The PK analysis included Kenyan and Ugandan children participating in the LIVING studies (NCT02346487) receiving LPV/r pellets (40/10 mg) and ABC/3TC (60/30 mg) dispersible tablets. Population PK models were developed for lopinavir (LPV) and ritonavir (RTV) to evaluate the impact of RTV on the oral clearance (CL/F) of LPV. The data obtained from the study were analyzed using nonlinear mixed‐effects modeling approach. Data from 514 children, comprising a total of 2,998 plasma concentrations of LPV/r were included in the analysis. The LPV and RTV concentrations were accurately represented by a one‐compartment model with first‐order absorption (incorporating a lag‐time) and elimination. Body weight influenced LPV and RTV PK parameters. The impact of RTV concentrations on the CL/F of LPV was characterized using a maximum effect model. Simulation‐predicted target LPV exposures were achieved in children with this pellet formulation across the WHO weight bands. The LPV/r pellets dosed in accordance with WHO weight bands provide adequate LPV exposures in Kenyan and Ugandan children weighing 3.0 to 24.9 kg. [ABSTRACT FROM AUTHOR]

Published
2024
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43. Activated NK Cells with Pro-inflammatory Features are Associated with Atherogenesis in Perinatally HIV-Acquired Adolescents

Author

Alles, Mario, primary, Gunasena, Manuja, additional, Kettelhut, Aaren, additional, Ailstock, Kate, additional, Musiime, Victor, additional, Kityo, Cissy, additional, Richardson, Brian, additional, Mulhern, Will, additional, Tamilselvan, Banumathi, additional, Rubsamen, Michael, additional, Kasturiratna, Dhanuja, additional, Demberg, Thorsten, additional, Cameron, Cheryl M., additional, Cameron, Mark J., additional, Dirajlal-Fargo, Sahera, additional, Funderburg, Nicholas T., additional, and Liyanage, Namal P.M., additional

Published
2023
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44. 93 Acceptability and Usability of Tablet-Based Neuropsychological Tests among South African and Ugandan Adolescents With and Without HIV

Author

Ferraris, Christopher M, primary, Dunayev, Rebecca, additional, Kanaan, Nour, additional, Kirsch, Courtney E, additional, Morrison, Corey, additional, Asiedu, Nana, additional, Tsapalas, Daphne, additional, Santoro, Anthony F, additional, Phillips, Nicole J, additional, Hoare, Jacqueline, additional, Nanteza, Angel, additional, Gumikiriza-Onoria, Joy L, additional, Musiime, Victor, additional, Dirajlal-Fargo, Sahera, additional, and Robbins, Reuben N, additional

Published
2023
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48. 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

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

Published
2023
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49. 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

50. 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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