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1. Low unspliced cell-associated HIV RNA in early treated adolescents living with HIV on long suppressive ART

Author

Kathleen Gärtner, Sara Domínguez-Rodríguez, Judith Heaney, Triantafylia Gkouleli, Paul Grant, Karim Dorgham, Delphine Sauce, Cathia Soulie, Eloise J. Busby, Denise M. O’Sullivan, Moira Spyer, Johannes C. Botha, Maria Angeles Muñoz-Fernandez, Alfredo Tagarro, Nicola Cotugno, Jim F. Huggett, Nigel Klein, Paolo Palma, Pablo Rojo Conejo, Caroline Foster, Carlo Giaquinto, Paolo Rossi, Deborah Persaud, Anita De Rossi, Anne-Geneviève Marcelin, and Eleni Nastouli

Subjects
HIV-1, adolescents, early treated, suppressed, cell-associated RNA, cell-associated DNA, Immunologic diseases. Allergy, RC581-607
Abstract

IntroductionInitiation of antiretroviral treatment (ART) in patients early after HIV-infection and long-term suppression leads to low or undetectable levels of HIV RNA and cell-associated (CA) HIV DNA and RNA. Both CA-DNA and CA-RNA, overestimate the size of the HIV reservoir but CA-RNA as well as p24/cell-free viral RNA can be indicators of residual viral replication. This study describes HIV RNA amounts and levels of cytokines/soluble markers in 40 well-suppressed adolescents who initiated ART early in life and investigated which viral markers may be informative as endpoints in cure clinical trials within this population.MethodsForty adolescents perinatally infected with HIV on suppressive ART for >5 years were enrolled in the CARMA study. HIV DNA and total or unspliced CA-RNA in PBMCs were analyzed by qPCR/RT-qPCR and dPCR/RT-dPCR. Cell-free HIV was determined using an ultrasensitive viral load (US-VL) assay. Plasma markers and p24 were analyzed by digital ELISA and correlations between total and unspliced HIV RNA and clinical markers, including age at ART, Western Blot score, levels of cytokines/inflammation markers or HIV CA-DNA, were tested.ResultsCA-RNA was detected in two thirds of the participants and was comparable in RT-qPCR and RT-dPCR. Adolescents with undetectable CA-RNA showed significantly lower HIV DNA compared to individuals with detectable CA-RNA. Undetectable unspliced CA-RNA was positively associated with age at ART initiation and Western Blot score. We found that a higher concentration of TNF-α was predictive of higher CA-DNA and CA-RNA. Other clinical characteristics like US-VL, time to suppression, or percent CD4+ T-lymphocytes were not predictive of the CA-RNA in this cross-sectional study.ConclusionsLow CA-DNA after long-term suppressive ART is associated with lower CA-RNA, in concordance with other reports. Patients with low CA-RNA levels in combination with low CA-DNA and low Western Blot scores should be further investigated to characterize candidates for treatment interruption trials. Unspliced CA-RNA warrants further investigation as a marker that can be prioritized in paediatric clinical trials where the sample volume can be a significant limitation.

Published
2024
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2. Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group studyResearch in context

Author

Guy de Bruyn, Joyce Wang, Annie Purvis, Martin Sanchez Ruiz, Haritha Adhikarla, Saad Alvi, Matthew I. Bonaparte, Daniel Brune, Agustin Bueso, Richard M. Canter, Maria Angeles Ceregido, Sachin Deshmukh, David Diemert, Adam Finn, Remi Forrat, Bo Fu, Julie Gallais, Paul Griffin, Marie-Helene Grillet, Owen Haney, Jeffrey A. Henderson, Marguerite Koutsoukos, Odile Launay, Federico Martinon Torres, Roger Masotti, Nelson L. Michael, Juliana Park, Doris Maribel Rivera-Medina, Natalya Romanyak, Chris Rook, Lode Schuerman, Lawrence D. Sher, Fernanda Tavares-Da-Silva, Ashley Whittington, Roman M. Chicz, Sanjay Gurunathan, Stephen Savarino, Saranya Sridhar, Allaw Mohammed, Babin Valérie, Babyak Jennifer, Ines Ben-Ghezala, Thomas Breuer, Corinne Breymeier, Anne Conrad, Ciarrah Holmqvist, Cristiana Costa-Araujo, Florence Coux, Christine Dellanno, Bertrand Dussol, Brandon Essink, Jesús Garrido, Pierre-Olivier Girodet, Claudia Gonzalez, Marie-Ange Grosbois, Justin Hammond, Chelsea He, Ciarrah Homlqvist, Kathy Hudzina, Mark Hutchens, Peta-Gay Jackson Booth, Arnel Joaquin, Rama Kandasamy, Jennifer Kasztejna, Michael Keefer, Murray Kimmel, Matthew Kresge, Fabrice Laine, Maeva Lefebvre, Denise Lopez, Malaborbor Perpetua Lourdes, Zoha Maakaroun-Vermesse, Caitlin Malishchak, Lisa Menard, Sandra Mendoza, Patrick Moore, Mounika Mulamalla, Patrick Mulholland, Jean-Francois Nicolas, Onyema Ogbuagu, Juan Ortiz, Ana Paula Perroud, Gina Peyton, Ya-Fen Purvis, Vanessa Raabe, Enrique Rivas, Nadine Rouphael, Beatrice Roy, Lola Sagot, Nessryne Sater, Howard Schwartz, Randall Severance, Jiayuan Shi, Magdalena Sobieszczyk, Charlene Stevens, Tran Phuong Thuy, Ramy Toma, Tina Tong, Sophie Tourneux, John Treanor, Núria Turet, Rachel Froget, Stephen Walsh, Judith White, Victor del Campo Perez, Lina Perez Breva, Pablo Rojo Conejo, Maria Belen Ruiz Antoraz, Toong Chin, Charlotte Fribbens, Adrian Phillipson, Rachel Kaminski, Stevan Emmett, Corey Hebert, Thomas Birch, Russell Roberson, Jeffrey Zacher, Sophie Gelu-Maury, Loron Loryne, and Yvonne Davis

Subjects
AS03 adjuvant, Beta, Booster, B.1.351, COVID-19, CoV2 preS dTM-AS03, Medicine (General), R5-920
Abstract

Summary: Background: In a parallel-group, international, phase 3 study (ClinicalTrials.gov NCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03). Methods: Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. Participants were stratified by age (18–55 and ≥ 56 years) and received one of the following CoV2 preS dTM-AS03 booster formulations: MV(D614) (n = 1285), MV(B.1.351) (n = 707) or bivalent D614 + B.1.351 (BiV; n = 625). Unvaccinated adults who tested negative on a SARS-CoV-2 rapid diagnostic test (control group, n = 479) received two primary doses, 21 days apart, of MV(D614). Anti-D614G and anti-B.1.351 antibodies were evaluated using validated pseudovirus (lentivirus) neutralization (PsVN) assay 14 days post-booster (day [D]15) in 18–55-year-old BNT162b2-primed participants and compared with those pre-booster (D1) and on D36 in 18–55-year-old controls (primary immunogenicity endpoints). PsVN titers to Omicron BA.1, BA.2 and BA.4/5 subvariants were also evaluated. Safety was evaluated over a 12-month follow-up period. Planned interim analyses are presented up to 14 days post-last vaccination for immunogenicity and over a median duration of 5 months for safety. Findings: All three boosters elicited robust anti-D614G or -B.1.351 PsVN responses for mRNA, adenovirus-vectored and protein vaccine-primed groups. Among BNT162b2-primed adults (18–55 years), geometric means of the individual post-booster versus pre-booster titer ratio (95% confidence interval [CI]) were: for MV (D614), 23.37 (18.58–29.38) (anti-D614G); for MV(B.1.351), 35.41 (26.71–46.95) (anti-B.1.351); and for BiV, 14.39 (11.39–18.28) (anti-D614G) and 34.18 (25.84–45.22 (anti-B.1.351). GMT ratios (98.3% CI) versus post-primary vaccination GMTs in controls, were: for MV(D614) booster, 2.16 (1.69; 2.75) [anti-D614G]; for MV(B.1.351), 1.96 (1.54; 2.50) [anti-B.1.351]; and for BiV, 2.34 (1.84; 2.96) [anti-D614G] and 1.39 (1.09; 1.77) [anti-B.1.351]. All booster formulations elicited cross-neutralizing antibodies against Omicron BA.2 (across priming vaccine subgroups), Omicron BA.1 (BNT162b2-primed participants) and Omicron BA.4/5 (BNT162b2-primed participants and MV D614-primed participants). Similar patterns in antibody responses were observed for participants aged ≥56 years. Reactogenicity tended to be transient and mild-to-moderate severity in all booster groups. No safety concerns were identified. Interpretation: CoV2 preS dTM-AS03 boosters demonstrated acceptable safety and elicited robust neutralizing antibodies against multiple variants, regardless of priming vaccine. Funding: Sanofi and Biomedical Advanced Research and Development Authority (BARDA).

Published
2023
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3. Infecciones durante oxigenación de membrana extracorpórea

Author

Rosa María Calderón Checa, Pablo Rojo Conejo, Aranzazu Flavia González-Posada Flores, Ana María Llorente de la Fuente, Alba Palacios Cuesta, Juan Miguel Aguilar, and Sylvia Belda Hofheinz

Subjects
Extracorporeal membrane oxygenation, Nosocomial infection, Risk factors, Pediatrics, RJ1-570
Abstract

Resumen: Objetivo: Identificar factores de riesgo asociados con el desarrollo de infecciones nosocomiales en pacientes pediátricos asistidos con oxigenación por membrana extracorpórea (ECMO). Pacientes y métodos: Se han revisado de forma retrospectiva los pacientes que han recibido asistencia en ECMO de enero de 2011 a diciembre de 2014. Se han recogido datos demográficos, sobre la asistencia y sobre las infecciones que aparecen durante dicha asistencia. Resultados: En este periodo hubo 50 asistencias en ECMO. Veinte pacientes tuvieron 23 episodios de infección, de los que 16 fueron bacteriemias, siendo el microorganismo más frecuente el estafilococo coagulasa negativo (habiendo 2 casos de candidemia). En cuanto a los grupos de edad, el lugar y el tipo de canulación, la presencia de coagulopatía grave y la realización de intervenciones quirúrgicas durante la asistencia, ninguno de estos factores resultó un factor de riesgo de infección estadísticamente significativo. La duración media de soporte en ECMO fue significativamente mayor en los pacientes que tuvieron alguna infección (8,91 vs. 5,96 días; p=0,039). No hubo diferencias significativas en cuanto a la estancia en la Unidad de Cuidados Intensivos Pediátricos ni en cuanto a la supervivencia. Conclusiones: La incidencia de infección durante ECMO es muy alta y los pacientes que tienen una infección están asistidos un tiempo significativamente mayor, por lo que se deben instaurar medidas para prevenir la aparición de estas infecciones e intentar minimizar el tiempo de asistencia en ECMO. Abstract: Objective: To identify risk factors associated with infectious complications acquired by paediatric patients during extracorporeal life support (ECLS). Patients and methods: Patients under ECLS from January 2011 to December 2014 have been retrospectively reviewed and data on demographics, care and infectious complications were collected. Results: There were 50 ECLS assistances in the study period, of which 20 patients had 23 infectious complications: 16 were bloodstream infections, with coagulase negative staphylococci being the predominant isolate (there were 2 cases of candidaemia). Age, site of cannulation procedure, cannulation site, severe coagulopathy, and surgical interventions during assistance were analysed as risk factors for infectious complications, but no significant differences were found. ECLS duration was significantly longer in patients with infectious complications (8.91 vs 5.91 days; P=.039). There were no significant differences as regards Paediatric Intensive Care Unit (PICU) stay, or in survival. Conclusions: Infectious complications during ECLS are very common, and ECLS duration is significantly longer in patients with infections. Measures should be put in place to prevent infectious complications and reduce time on ECLS.

Published
2018
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4. Experience with infections in the use of extracorporeal membrane oxygenation

Author

Rosa María Calderón Checa, Pablo Rojo Conejo, Aranzazu Flavia González-Posada Flores, Ana María Llorente de la Fuente, Alba Palacios Cuesta, Juan Miguel Aguilar, and Sylvia Belda Hofheinz

Subjects
Oxigenación por membrana extracorpórea, Infección nosocomial, Factores de riesgo, Pediatrics, RJ1-570
Abstract

Objective: To identify risk factors associated with infectious complications acquired by paediatric patients during extracorporeal life support (ECLS). Patients and methods: Patients under ECLS from January 2011 to December 2014 have been retrospectively reviewed and data on demographics, care and infectious complications were collected. Results: There were 50 ECLS assistances in the study period, of which 20 patients had 23 infectious complications: 16 were bloodstream infections, with coagulase negative staphylococci being the predominant isolate (there were 2 cases of candidaemia). Age, site of cannulation procedure, cannulation site, severe coagulopathy, and surgical interventions during assistance were analysed as risk factors for infectious complications, but no significant differences were found. ECLS duration was significantly longer in patients with infectious complications (8.91 vs 5.91 days; P = .039). There were no significant differences as regards Paediatric Intensive Care Unit (PICU) stay, or in survival. Conclusions: Infectious complications during ECLS are very common, and ECLS duration is significantly longer in patients with infections. Measures should be put in place to prevent infectious complications and reduce time on ECLS. Resumen: Objetivo: Identificar factores de riesgo asociados con el desarrollo de infecciones nosocomiales en pacientes pediátricos asistidos con oxigenación por membrana extracorpórea (ECMO). Pacientes y métodos: Se han revisado de forma retrospectiva los pacientes que han recibido asistencia en ECMO de enero de 2011 a diciembre de 2014. Se han recogido datos demográficos, sobre la asistencia y sobre las infecciones que aparecen durante dicha asistencia. Resultados: En este periodo hubo 50 asistencias en ECMO. Veinte pacientes tuvieron 23 episodios de infección, de los que 16 fueron bacteriemias, siendo el microorganismo más frecuente el estafilococo coagulasa negativo (habiendo 2 casos de candidemia). En cuanto a los grupos de edad, el lugar y el tipo de canulación, la presencia de coagulopatía grave y la realización de intervenciones quirúrgicas durante la asistencia, ninguno de estos factores resultó un factor de riesgo de infección estadísticamente significativo. La duración media de soporte en ECMO fue significativamente mayor en los pacientes que tuvieron alguna infección (8,91 vs. 5,96 días; p = 0,039). No hubo diferencias significativas en cuanto a la estancia en la Unidad de Cuidados Intensivos Pediátricos ni en cuanto a la supervivencia. Conclusiones: La incidencia de infección durante ECMO es muy alta y los pacientes que tienen una infección están asistidos un tiempo significativamente mayor, por lo que se deben instaurar medidas para prevenir la aparición de estas infecciones e intentar minimizar el tiempo de asistencia en ECMO.

Published
2018
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6. Neuropsychiatric Manifestations and Sleep Disturbances in Children and Adolescents Randomised to Dolutegravir-Based Antiretroviral Therapy vs Standard-of-Care in the Odyssey Trial

Author

Anna Turkova, Ellen White, Adeodata R. Kekitiinwa, Vivian Mumbiro, Elizabeth Kaudha, Afaaf Liberty, Grace Miriam Ahimbisibwe, Tumelo Moloantoa, Ussanee Srirompotong, Nozibusiso Rejoice Mosia, Thanyawee Puthanakit, Robin Kobbe, Clàudia Fortuny, Hajira Kataike, Dickson Bbuye, Sathaporn Na-Rajsima, Alexandra Coelho, Abbas Lugemwa, Mutsa F. Bwakura-Dangarembizi, Nigel Klein, Hilda Mujuru, Cissy Kityo, Mark F. Cotton, Rashida Abbas Ferrand, Carlo Giaquinto, Pablo Rojo Conejo, Avy Violari, Diana M. Gibb, Deborah Ford, and ODYSSEY Trial Team

Published
2023

7. Prevalence, clinical expression, invasiveness and outcome of Staphylococcus aureus containing Panton-Valentine leukocidin in children treated in a university hospital of Lithuania

Author

Astra Vitkauskiene, Lina Jankauskaite, Ausra Snipaitiene, Vaidotas Gurskis, Pablo Rojo Conejo, Birute Petraitiene, Rimantas Kevalas, and Giedre Trumpulyte

Subjects
0301 basic medicine, Microbiology (medical), General Immunology and Microbiology, business.industry, 030106 microbiology, Leukocidin, General Medicine, respiratory system, biochemical phenomena, metabolism, and nutrition, bacterial infections and mycoses, medicine.disease_cause, University hospital, Virulence factor, Microbiology, 03 medical and health sciences, 0302 clinical medicine, Infectious Diseases, Staphylococcus aureus, medicine, bacteria, 030212 general & internal medicine, Panton–Valentine leukocidin, skin and connective tissue diseases, business
Abstract

Background: There is a high prevalence of Staphylococcus aureus virulence factor Panton-Valentine leukocidin (PVL) in North-East parts of Europe. The aim was to evaluate data regarding the PVL occu...

Published
2020

8. 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

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

Subjects
Adult, Epidemiology, Pyridones, Anti-HIV Agents, Immunology, HIV Infections, 3-Ring, Piperazines, Heterocyclic Compounds, Virology, Oxazines, Humans, Protease Inhibitors, Child, Preschool, Infant, Newborn, Infant, Bayes Theorem, Viral Load, Newborn, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Infectious Diseases, Child, Preschool, Heterocyclic Compounds, 3-Ring, Treatment Outcome
Abstract

Contains fulltext : 283099.pdf (Publisher’s version ) (Open Access) BACKGROUND: Young children living with HIV have few treatment options. We aimed to assess the efficacy and safety of dolutegravir-based antiretroviral therapy (ART) in children weighing between 3 kg and less than 14 kg. METHODS: ODYSSEY is an open-label, randomised, non-inferiority trial (10% margin) comparing dolutegravir-based ART with standard of care and comprises two cohorts (children weighing ≥14 kg and

Published
2022

9. Congenital cytomegalovirus infection in newborns born to HIV-infected mothers

Author

Luis M. Prieto, Daniel Blázquez Gamero, Irene Rubio Mancha, Belén Torres Pastor, Cristina Epalza Ibarrondo, Pablo Rojo Conejo, José Tomás Ramos Amador, Elisa Fer-nández Cooke, Ángela Manzanares, Diana Mazariegos, Cinta Moraleda, Alberto Muñoz, David Torres Fernández, and Serena Villaverde

Subjects
Infant, Newborn, Infant, Mothers, HIV Infections, Infectious Disease Transmission, Vertical, Infant, Newborn, Diseases, Fetal Diseases, Anti-Retroviral Agents, Pregnancy, Cytomegalovirus Infections, Humans, Female, Pregnancy Complications, Infectious, Child, Retrospective Studies
Abstract

Congenital citomegalovirus (CMVc) infection is more common in children exposed to HIV during pregnancy, with reported rates in pre-ART era from 2 to 7%. The use of combined antiretroviral treatment (ARTc) could be a determining factor in reducing this risk of CMV transmission. The aim of this study was to describe the epidemiology of CMVc infection in newborns of HIV-infected mothers at Hospital Universitario 12 de Octubre, Madrid, Spain, from 2000 to 2017.An observational and retrospective study was carried out. Epidemiological and clinical variables were collected. Statistical analysis was performed with the SPSS 24.0 computer program.288 mother-infant pairs were included in the study. We observed a CMVc rate of 2.1% (95% CI 0.9-4.9).The rate of CMVc in HIV-exposed children observed was lower than that reported in pre-ARTc era but seems higher than those described in general population.

Published
2022

10. 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

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

Subjects
Male, Adolescent, Pyridones, Epidemiology, Immunology, Infant, HIV Infections, 3-Ring, Piperazines, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Infectious Diseases, Child, Child, Preschool, Female, Heterocyclic Compounds, 3-Ring, Humans, Oxazines, Rifampin, Uganda, HIV-1, Tuberculosis, Heterocyclic Compounds, Virology, Preschool
Abstract

Contains fulltext : 282959.pdf (Publisher’s version ) (Open Access) BACKGROUND: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. METHODS: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to

Published
2022

11. Determinants of precocious B-cell aging in European adolescents living with perinatally acquired HIV-1 after over 10 years of suppressive therapy

Author

Kinga K. Smolen, Katherine Luzuriaga, Alessandra Ruggiero, Philip J. R. Goulder, Carlo Giaquinto, Elena Morrocchi, Caroline Foster, Benoit Fatou, Nigel Klein, Eleni Nastouli, Ofer Levy, Savita Pawha, Stefano Rinaldi, Sara Domínguez-Rodríguez, Anita De Rossi, Pablo Rojo Conejo, Paolo Palma, Alfredo Tagarro, Alasdair Bamford, Nicola Cotugno, Giuseppe Rubens Pascucci, Hanno Steen, Paolo Rossi, and Al Ozonoff

Subjects
LAG3, biology, business.industry, T cell, Lymphoproliferative disorders, medicine.disease, Virus, medicine.anatomical_structure, Immune system, TIGIT, Immunology, biology.protein, medicine, Antibody, business, B cell
Abstract

HIV infection results in a state of chronic immune activation leading to premature immune aging, B-cells dysfunction, that persists despite prolonged virological suppression. In this scenario, adolescence living with perinatally acquired HIV (PHIV), deserve a peculiar attention since potentially exposed for their entire life to chronic immune activation. Here we identified determinants of precocious aging B cells in 40 PHIV undergoing suppressive antiretroviral therapy (ART) for median 13.5 years. All individuals started ART by 2nd year of life and achieved virus suppression within the 1st year of ART, with majority of patient maintaining suppression until analysis and 5/40 experiencing viral Spike (transient elevation of HIV-1 VL, 50-999 copies/ml). We employed a multiomics approach including deep immunological B and T cell phenotype in PBMC, with aging B cells defined by the expression of T-bet and CD11c; plasma proteomics analysis by mass spectrometry and serum level of anti-measles antibodies as correlates of humoral response. We found that individuals with expansion of aging B cell, defined by the expression of T-bet+CD11c+, were those starting treatment later, presenting detectable levels of cell-associated HIV-1 RNA, history of Spikes, and a higher frequency of exhausted T-cells, including those expressing PD-1, LAG3, TIGIT. Accordingly, the proteomic analysis revealed that subjects with expansion of aging B cells and exhausted T cells had enrichment of proteins involved in immune inflammation and complement activation pathways, such as CLU and APCS which are also involved in tumor progression. Signs of precocious aging were associated with a reduced capacity to maintain virological memory against measles vaccination. To our knowledge, this is the first study focusing on precocious B-cell aging and dysfunctionality in PHIV with long-term virological suppression. Our experimental strategy enabled identification of clinical, viral, cellular and plasma soluble markers associated with B-cells aging. Our results pave the way to further define risk of disease progression or lymphoproliferative disorders in PHIV.Author summaryDespite a successful antiretroviral therapy (ART), adolescence living with perinatally acquired HIV (PHIV) experience B-cells dysfunction, including loss of vaccine-induced immunological memory and higher risk of developing B-cells associated tumors. It is thus paramount to define novel and precise correlates of precious aging B cell for the definition of novel therapeutic strategies. Here, we studied 40 PHIV who started treatment by 2nd year of life and maintain virological suppression for 13.5 years, with 5/40 patients experiencing transient elevation of the HIV-1 load in the plasma (Spike). We applied a multi-omics approach including immunological B and T cell phenotype, plasma proteomics analysis and serum level of anti-measles antibodies as functional correlates of vaccine-induced immunity. We found that levels of aging B cells were positively associated with age at ART start, cell associated HIV-1 RNA (caHIV-1 RNA) and the presence of Spikes. Individuals with increased proportions of aging B cells had concomitant expansion of exhausted T cells and were unable to maintain vaccine-induced immunity over time. B-cell aging, and T-cell exhaustion were also associated with proteins involved in immune inflammation. The factors found here to be associated with aging B-cell could inform further therapeutic studies.

Published
2021

12. Ventricular Repolarization Parameters and Coronary Involvement in Kawasaki Disease

Author

Ana Barrios-Tascón, Masaru Miura, Sara Domínguez-Rodríguez, Elisa Fernández-Cooke, Georgia Sarquella-Brugada, Alfredo Tagarro, Elisa Fernandez-Cooke, Cristina Calvo, Judith Sánchez-Manubens, Jordi Antón, Javier Aracil Santos, Esmeralda Nuñez Cuadros, Maria Luisa Navarro Gómez, David Moreno Pérez, María Martín Cantero Pérez, Esmeralda Nuñez Cuadros Pérez, Begoña Carazo Gallego Pérez, Fernando Sánchez García, Marisol Camacho Lovillo, Renata Marqués, Olaf Neth Laura, Fernández Silveira, Miguel Sánchez Forte, Ángeles Ortega Montes, Leticia Isabel Martínez Campos, Beatriz Bravo Mancheño, Margarita Camacho, Antonio F. Medina Claros, Carlos Salido, María Torres Rico, Beatriz Ruiz Saez, Elena Fernadez de la Puebla Lechuga, Ma José Lirola Cruz, Kety Maya Carrasco, Moisés Rodríguez González, Enrique Blanca Jover, José Uberos Fernández, María Mercedes Ibáñez Alcalde, Miguel Lafuente Hidalgo, Lorenzo Jiménez Montañés, Matilde Bustillo Alonso, Ariadna Ayerza Casas, Bárbara Montes Zapico, Carlos Pérez Méndez, Javier Fernández Aracama, Lucía Rodríguez, María Aleida Ibáñez Fernández, Sandra Navarro Campo, Silvia Escribà Bori, María Concepción Mir Perelló, Ma Ángeles de la Fuente Sánchez, Patricia Aparicio García, Carlos Briales, Joaquín Castilla Crespí, María Elena Colino Gil, Nerea Delgado Cabrera, Ana Bello Naranjo, Jesús Poch Páez, Moneyba García Yáñez, Montse González García, Maite Viadero, Beatriz Jiménez Montero, Olga Domínguez García, Begoña Losada Pinedo, Gema Iñigo Martín, Lucía María Escribano Gómez, Antonio Cepillo, Miguel Lillo Lillo, María Isabel Buedo, Laura del Rey, Elena Urbaneja Rodríguez, Sara Rellán Rodríguez, Teresa Cantero, Beatriz Plata Izquierdo, Luisa García-Cuenllas Álvarez, Ignacio Oulego Erroz, Elena Pérez Santaolalla, Carlos Alcalde Martín, Fernando Centeno Malfaz, Elena Pérez Gutiérrez, Ma Soledad Jiménez Casso, Fredy Prada, Rosa Bou, Estibaliz Iglesias, Joan Calzada, Olga Calavia Garsaball, Marc Tobeña Rue, Gemma Giralt García, Zulema Lobato, Neus Rius Gordillo, Montserrat Pascual Torres, María Méndez Hernández, Lourdes García, Sergio Flores Villar, Silvia Yevenes Ruiz, Laura Minguell Domingo, Anna Ballester, Ana Miralles, Berta Pujol Soler, Anton Foguet Vidal, Pere Sala Castellví, Angelita Serrano Aguiar, José Manuel Siurana Rodríguez, Anna Sangorrin Iranzo, Roser Álvarez Pérez, Paula Ribes Cajas, Pere Genaró i Jornet, Ana Grande Tejada, Cristina Zarallo, Federico Martinón-Torres, Irene Rivero Calle, Antonio Justicia Grande, María López Sousa, Alejandro Souto Vilas, Bernardo López Abel, Elisa de Miguel Esteban, Bibiana Riaño Méndez, Daniel Blázquez, Pablo Rojo Conejo, Carlos Grasa Lozano, Belén Toral, Leticia Albert De la Torre, Jaime de Inocencio, Mar Santos, Rafael Díaz-Delgado de la Peña, Paz Collado Ramos, Teresa Raga, Libertad Latorre, Sara Guillén, Ignacio Callejas Caballero, Luis Manuel Prieto Tato, María Fernanda Guzmán Monagas, Isabel Jiménez López, Sandra Villagrá, Viviana Arreo, Roi Piñeiro Pérez, María de la Parte, Amalia Tamariz-Martes, Marta Llorente Romano, Maria Belén Hernández Rupérez, Henar Rojo Sombrero, Estefanía García Cerro, Irene Maté Cano, Marta Villares Alonso, Marta Pilar Osuna Marco, Julia Jensen Veron, Cristina Zarallo Reales, María Dolores Rodríguez Mesa, Santiago Rueda Esteban, José Tomás Ramos Amador, Cristina González Menchén, Ana Belén Jiménez Jiménez, Pilar Galán, Dolores Pérez Campos, Ma Mercedes Bueno, David Crespo Marcos, Enrique Otheo de Tejada Barásoain, Walter Alberto Sifuentes Giraldo, María Luz Gámir Gámir, María José Cilleruelo Ortega, Agustín López López, Cristina Sánchez Vaquerizo, Ana Isabel Usano Carrasco, Ester Moreno Gómez, Olga Carvajal del Castillo, Beatriz Del Pozo Menéndez, Katie Badillo Navarro, Fernando Baquero, Lucía Deiros Bronte, Pablo Fernández Fraga, Nieves Domínguez, Beatriz Mercader Rodríguez, Francisco Castro García, Águeda Herrera Chamorro, Paula Alcañiz Rodríguez, Moisés Sorlí García, María Concepción Rex Nicolás, Elena Vera Romero, Patricia Martínez Olorón, Beatriz Rocandio Cilveti, Amaia Berridi, Laura Santos-Díez Vázquez, Olaia Fernández, Inmaculada Calvo, Belén Fernández Tudela, Manuel Oltra Benavent, Marta Dapena Archilés, Franciasco Sanchez Ferrer, César Gavilán, Ignacio Izquierdo Fos, María Isabel Serrano Robles, Yolanda Herranz Sánchez, Enrique Villalobos Pinto, Daniel Clemente Garulo, Stella Pie, Manuel Marrero Calvo, and José María Olmos García

Subjects
Male, medicine.medical_specialty, Ventricular Repolarization, Heart Diseases, Heart Ventricles, Enfermedad cardiovascular, Coronary disease, Mucocutaneous Lymph Node Syndrome, QT interval, 03 medical and health sciences, Recovery period, Electrocardiography, 0302 clinical medicine, Heart Conduction System, 030225 pediatrics, Internal medicine, medicine, Humans, In patient, 030212 general & internal medicine, Enfermedad coronaria, business.industry, Pediatría, Infant, Reproducibility of Results, medicine.disease, Increased risk, Cross-Sectional Studies, Síndrome mucocutáneo linfonodular, Child, Preschool, Pediatrics, Perinatology and Child Health, Cardiology, Kawasaki disease, Female, business
Abstract

Objectives: To evaluate electrocardiogram markers to predict coronary involvement in patients with Kawasaki disease by assessing measures of ventricular repolarization parameters on the 12-lead electrocardiogram. Study design: This cross-sectional study included 180 Spanish and Japanese patients ≤14 years of age with Kawasaki disease, with or without coronary involvement, from 2011 to 2016. We manually measured the Tp-Te/QT ratio and QTc interval (with Bazett's formula) in 12-lead electrocardiogram in the acute and recovery period and explored their potential association with coronary involvement. Results: No association was found between Tp-Te/QT ratio obtained manually in V5 and V6 leads and coronary involvement in the acute (V5:0.25 [IQR, 0.21-0.27] vs 0.25 [IQR, 0.20-0.27], P = .80; V6:0.24 [IQR, 0.21-0.27] vs 0.25 [IQR, 0.20-0.27], P = .86) or the recovery (V5: 0.23 [IQR, 0.20-0.25] vs 0.23 [IQR, 0.19-0.25], P = .68; V6: 0.23 [IQR, 0.20-0.25] vs 0.23 [IQR, 0.17-0.25], P = .50) period. By contrast, QTc in V5 and V6 was significantly lower in patients with Kawasaki disease and coronary involvement in the acute period (V5: 378 ms [IQR, 364-395 ms] vs 390 ms [IQR, 371-411 ms], P = .04; V6: 377 ms [IQR, 364-392 ms] vs 390 ms [IQR, 371-410 ms], P = .01). A QTc interval of

Published
2021

13. Determinants of Precocious B-Cell Aging in European Adolescents Living With Perinatally Acquired HIV-1 After Over 10 Years of Suppressive Therapy

Author

Alessandra Ruggiero, Giuseppe Rubens Pascucci, Nicola Cotugno, Sara Domínguez-Rodríguez, Stefano Rinaldi, Alfredo Tagarro, Pablo Rojo Conejo, Caroline Foster, Alasdair Bamford, Anita De Rossi, Eleni Nastouli, Nigel Klein, Elena Morrocchi, Benoit Fatou, Smolen K. Kinga, Al Ozonoff, Luzuriaga Katherine, Hanno Steen, Carlo Giaquinto, Philip Goulder, Paolo Rossi, Levy Ofer, Savita Pahwa, Paolo Palma, and on behalf of the EPIICAL consortium

Subjects
History, Polymers and Plastics, Business and International Management, Industrial and Manufacturing Engineering
Published
2021

14. Prevalence, clinical expression, invasiveness and outcome of

Author

Birute, Petraitiene, Pablo Rojo, Conejo, Lina, Jankauskaite, Rimantas, Kevalas, Giedre, Trumpulyte, Ausra, Snipaitiene, Astra, Vitkauskiene, and Vaidotas, Gurskis

Subjects
Methicillin-Resistant Staphylococcus aureus, Staphylococcus aureus, Bacterial Toxins, Exotoxins, Lithuania, Staphylococcal Infections, Community-Acquired Infections, Europe, Leukocidins, Prevalence, Humans, Prospective Studies, Child, Aged
Published
2020

15. Infecciones durante oxigenación de membrana extracorpórea

Author

Pablo Rojo Conejo, Juan Miguel Aguilar, Sylvia Belda Hofheinz, Rosa María Calderón Checa, Alba Palacios Cuesta, Ana María Llorente de la Fuente, and Aranzazu Flavia González-Posada Flores

Subjects
03 medical and health sciences, 0302 clinical medicine, Nosocomial infection, Extracorporeal membrane oxygenation, Risk factors, Pediatrics, Perinatology and Child Health, 030212 general & internal medicine, 030204 cardiovascular system & hematology, Pediatrics, RJ1-570
Abstract

Resumen: Objetivo: Identificar factores de riesgo asociados con el desarrollo de infecciones nosocomiales en pacientes pediátricos asistidos con oxigenación por membrana extracorpórea (ECMO). Pacientes y métodos: Se han revisado de forma retrospectiva los pacientes que han recibido asistencia en ECMO de enero de 2011 a diciembre de 2014. Se han recogido datos demográficos, sobre la asistencia y sobre las infecciones que aparecen durante dicha asistencia. Resultados: En este periodo hubo 50 asistencias en ECMO. Veinte pacientes tuvieron 23 episodios de infección, de los que 16 fueron bacteriemias, siendo el microorganismo más frecuente el estafilococo coagulasa negativo (habiendo 2 casos de candidemia). En cuanto a los grupos de edad, el lugar y el tipo de canulación, la presencia de coagulopatía grave y la realización de intervenciones quirúrgicas durante la asistencia, ninguno de estos factores resultó un factor de riesgo de infección estadísticamente significativo. La duración media de soporte en ECMO fue significativamente mayor en los pacientes que tuvieron alguna infección (8,91 vs. 5,96 días; p=0,039). No hubo diferencias significativas en cuanto a la estancia en la Unidad de Cuidados Intensivos Pediátricos ni en cuanto a la supervivencia. Conclusiones: La incidencia de infección durante ECMO es muy alta y los pacientes que tienen una infección están asistidos un tiempo significativamente mayor, por lo que se deben instaurar medidas para prevenir la aparición de estas infecciones e intentar minimizar el tiempo de asistencia en ECMO. Abstract: Objective: To identify risk factors associated with infectious complications acquired by paediatric patients during extracorporeal life support (ECLS). Patients and methods: Patients under ECLS from January 2011 to December 2014 have been retrospectively reviewed and data on demographics, care and infectious complications were collected. Results: There were 50 ECLS assistances in the study period, of which 20 patients had 23 infectious complications: 16 were bloodstream infections, with coagulase negative staphylococci being the predominant isolate (there were 2 cases of candidaemia). Age, site of cannulation procedure, cannulation site, severe coagulopathy, and surgical interventions during assistance were analysed as risk factors for infectious complications, but no significant differences were found. ECLS duration was significantly longer in patients with infectious complications (8.91 vs 5.91 days; P=.039). There were no significant differences as regards Paediatric Intensive Care Unit (PICU) stay, or in survival. Conclusions: Infectious complications during ECLS are very common, and ECLS duration is significantly longer in patients with infections. Measures should be put in place to prevent infectious complications and reduce time on ECLS.

Published
2018

16. Prevention and treatment of fetal cytomegalovirus infection with cytomegalovirus hyperimmune globulin: a multicenter study in Madrid

Author

Antonio García-Burguillo, José Tomás Ramos-Amador, Daniel Blázquez-Gamero, María Isabel González-Tomé, Virginia Sánchez, Fernando Baquero-Artigao, María Soriano-Ramos, Teresa Del Rosal, Noelia Perez, Pablo Rojo Conejo, Alberto Galindo Izquierdo, María de la Calle, and Nuria Méndez

Subjects
Adult, Hyperimmune globulin, medicine.medical_specialty, Amniotic fluid, Congenital cytomegalovirus infection, Ultrasonography, Prenatal, Tertiary Care Centers, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, Internal medicine, Humans, Medicine, 030212 general & internal medicine, Pregnancy Complications, Infectious, Retrospective Studies, Fetus, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, biology, business.industry, Infant, Newborn, Immunoglobulins, Intravenous, Infant, virus diseases, Obstetrics and Gynecology, Retrospective cohort study, Amniotic Fluid, medicine.disease, Infectious Disease Transmission, Vertical, Cytomegalovirus infection, Fetal Diseases, Multicenter study, Spain, Cytomegalovirus Infections, Pediatrics, Perinatology and Child Health, Immunology, Amniocentesis, biology.protein, Female, business
Abstract

Cytomegalovirus (CMV) is the leading cause of congenital infection worldwide. Data about the management of CMV infection in pregnant women are scarce, and treatment options are very limited. The aim of the study is to investigate the effectiveness of cytomegalovirus hyperimmune globulin (CMV-HIG) for the prevention and treatment of congenital CMV (cCMV) infection.A retrospective observational study was conducted in three tertiary hospitals in Madrid. In the period 2009-2015, CMV-HIG (CytotectThirty-six pregnant women were included. Median gestational age at birth was 39 weeks (interquartile range: 38-40) and two children (5.5%) were premature (born at 28 and 34 weeks' gestation). Amniocentesis was performed in 30/36 (83.4%) pregnancies and CMV PCR was positive in 21 of them (70%). One fetus with a positive PCR in amniotic fluid that received one dose of HIG after amniocentesis presented a negative CMV-PCR in urine at birth, and was asymptomatic at 12 months of age. Twenty-four children were infected at birth, and 16/21 (76.2%) presented no sequelae at 12 months, while two (9.5%) had a mild unilateral hearing loss and three (14.3%) severe hearing loss or neurological sequelae. Seventeen women were included in the PG and 19 in the TG. In the PG 7/17 (41%) fetuses were infected, one pregnancy was terminated due to abnormalities in cordocentesis and one showed a mild hearing loss at 12 months of age. In the TG, 18/19 children (95%) were diagnosed with cCMV, while the remaining neonate had negative urine CMV at birth. Eight out of the 19 fetuses (42.1%) showed CMV related abnormalities in the fetal US before HIG treatment. Complete clinical assessment in the neonatal period and at 12 months of age was available in 16 and 15 children, respectively. At birth 50% were symptomatic and at 12 months of age, 4/15 (26.7%) showed a hearing loss and 3/15 (20%) neurologic impairment. Fetuses with abnormalities in ultrasonography before HIG presented a high risk of sequelae (odds ratios: 60; 95%CI: 3-1185; p = .007).Prophylactic HIG administration in pregnant women after CMV primary infection seems not to reduce significantly the rate of congenital infection, but is safe and it could have a favorable effect on the symptoms and sequelae of infected fetuses. The risk of long-term sequelae in fetuses without US abnormalities before HIG is low, so it could be an option in infected fetuses with normal imaging. On the other hand, the risk of sequelae among infected fetuses with abnormalities in fetal ultrasonography before HIG despite treatment is high.

Published
2017

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

Author

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

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Pediatrics, Adolescent, Epidemiology, Immunology, Infectious Diseases, Virology, International Cooperation, 610 Medicine & health, HIV Infections, Global Health, Article, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Acquired immunodeficiency syndrome (AIDS), 360 Social problems & social services, medicine, Humans, Cumulative incidence, 030212 general & internal medicine, Child, Proportional hazards model, business.industry, Drug Substitution, Incidence (epidemiology), Incidence, Infant, Newborn, Infant, Viral Load, medicine.disease, 030112 virology, CD4 Lymphocyte Count, Regimen, Observational Studies as Topic, Anti-Retroviral Agents, Child, Preschool, Cohort, Female, business, Viral load
Abstract

BACKGROUND Estimates of incidence of switching to second-line antiretroviral therapy (ART) among children with HIV are necessary to inform the need for paediatric second-line formulations. We aimed to quantify the cumulative incidence of switching to second-line ART among children in an international cohort collaboration. METHODS In this international cohort collaboration study, we pooled individual patient-level data for children younger than 18 years who initiated ART (two or more nucleoside reverse-transcriptase inhibitors [NRTI] plus a non-NRTI [NNRTI] or boosted protease inhibitor) between 1993 and 2015 from 12 observational cohort networks in the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Global Cohort Collaboration. Patients who were reported to be horizontally infected with HIV and those who were enrolled in trials of treatment monitoring, switching, or interruption strategies were excluded. Switch to second-line ART was defined as change of one or more NRTI plus either change in drug class (NNRTI to protease inhibitor or vice versa) or protease inhibitor change, change from single to dual protease inhibitor, or addition of a new drug class. We used cumulative incidence curves to assess time to switching, and multivariable proportional hazards models to explore patient-level and cohort-level factors associated with switching, with death and loss to follow-up as competing risks. FINDINGS At the data cutoff of Sept 16, 2015, 182 747 children with HIV were included in the CIPHER dataset, of whom 93 351 were eligible, with 83 984 (90·0%) from sub-Saharan Africa. At ART initiation, the median patient age was 3·9 years (IQR 1·6-6·9) and 82 885 (88·8%) patients initiated NNRTI-based and 10 466 (11·2%) initiated protease inhibitor-based regimens. Median duration of follow-up after ART initiation was 26 months (IQR 9-52). 3883 (4·2%) patients switched to second-line ART after a median of 35 months (IQR 20-57) of ART. The cumulative incidence of switching at 3 years was 3·1% (95% CI 3·0-3·2), but this estimate varied widely depending on the cohort monitoring strategy, from 6·8% (6·5-7·2) in settings with routine monitoring of CD4 (CD4% or CD4 count) and viral load to 0·8% (0·6-1·0) in settings with clinical only monitoring. In multivariable analyses, patient-level factors associated with an increased likelihood of switching were male sex, older age at ART initiation, and initial NNRTI-based regimen (p

Published
2019

18. Role of Magnetic Resonance Imaging and Cranial Ultrasonography in Congenital Cytomegalovirus Infection

Author

Ana Martínez de Aragón, Claudia Fortuny Guasch, Ana Filgueira Posse, Mar Santos, Daniel Blázquez-Gamero, Almudena Alonso-Ojembarrena, Marie Antoinette Frick, Itziar Sota Busselo, Fernando Baquero-Artigao, Antoni Noguera-Julian, Elisa Garrote Llanos, Alfredo Tagarro García, Pere Soler-Palacín, María Soriano-Ramos, Pablo Rojo Conejo, Jorge Bustamante, María Teresa Rives Ferreiro, and Elisenda Moliner Calderón

Subjects
Male, Microbiology (medical), medicine.medical_specialty, MEDLINE, Neuroimaging, Ultrasonografía, medicine, Humans, Longitudinal Studies, Prospective Studies, Prospective cohort study, Tecnología médica, Ultrasonography, Espectroscopía de resonancia magnética, medicine.diagnostic_test, business.industry, Infant, Newborn, Brain, Infant, Magnetic resonance imaging, Prognosis, Magnetic Resonance Imaging, Virus, Infectious Diseases, Multicenter study, Spain, Cytomegalovirus Infections, Pediatrics, Perinatology and Child Health, Citomegalovirus, Female, Radiology, business
Abstract

Sin financiación 2.126 JCR (2019) Q4, 123/159 Immunology 1.139 SJR (2019) Q1, 39/311 Pediatrics, Perinatology and Child Health No data IDR 2019 UEM

Published
2019

19. Immunisation practices in centres caring for children with perinatally acquired HIV: A call for harmonisation

Author

Alasdair Bamford, Emma C. Manno, Maria Jose Mellado, Vana Spoulou, Laura Marques, Henriette J. Scherpbier, Tim Niehues, Agnieszka Oldakowska, Paolo Rossi, Paolo Palma, Esse N. Menson, M. Ángeles Muñoz-Fernández, Marinella Della Negra, Delane Shingadia, Jack Levy, Magdalena Marczynska, Pablo Rojo Conejo, Nigel Klein, Jintanat Ananworanich, John Bernard Ziegler, Hermione Lyall, Antonio Di Biagio, Vania Giacomet, Guido Castelli Gattinara, Heloisa Helena De Sousa Marques, Nicola Cotugno, Eeva Salo, Alla Volokha, Mariana Mardarescu, Veronique Reliquet, Stefania Bernardi, Carlo Giaquinto, Paediatric Infectious Diseases / Rheumatology / Immunology, and Other departments

Subjects
Male, 0301 basic medicine, Health Knowledge, Attitudes, Practice, Pediatrics, Vaccination Coverage, Human immunodeficiency virus (HIV), HIV Infections, Computer-assisted web interviewing, medicine.disease_cause, 0302 clinical medicine, Practices, Surveys and Questionnaires, Rotavirus, 030212 general & internal medicine, Practice Patterns, Physicians', Survey, Child, Children, Vaccines, education.field_of_study, Attenuated vaccine, Vaccination, Infectious Diseases, Child, Preschool, Molecular Medicine, Female, Attitudes, HIV, Vaccinations, medicine.medical_specialty, Population, Vaccines, Attenuated, 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), medicine, Humans, education, Immunization Schedule, Settore MED/38 - Pediatria Generale e Specialistica, General Veterinary, General Immunology and Microbiology, Immunization Programs, business.industry, Public Health, Environmental and Occupational Health, Infant, medicine.disease, Infectious Disease Transmission, Vertical, 030104 developmental biology, Family medicine, Healthcare settings, business
Abstract

Background Current national immunisation schedules differ between countries in terms of vaccine formulation, timing of vaccinations and immunisation programme funding and co-ordination. As a result, some HIV infected paediatric population may be left susceptible to vaccine preventable infections. Vaccines used in healthy population should be subjected to high quality ethical research and be explicitly validated for use in children with special vaccination needs such as those infected with HIV. This survey was completed to assess current vaccination practices and attitudes toward vaccination among pediatricians who care for vertically HIV infected children. Methods An online questionnaire was completed by 46 experts in paediatric HIV-infection from the Paediatric European Network for Treatment of AIDS (PENTA). Data were collected between November 2013 and March 2014. Results 46 units looking after 2465 patients completed the questionnaire. The majority of units (67%) reported that common childhood immunisation were administered by the family doctor or local health services rather than in the HIV specialist centre. Vaccination histories were mostly incomplete and difficult to obtain for 40% of the studied population. Concerns were reported regarding the use of live attenuated vaccines, such as varicella and rotavirus, and these were less frequently recommended (61% and 28% of the units respectively). Monitoring of vaccine responses was employed in a minority of centres (41%). A range of different assays were used resulting in diverse units of measurement and proposed correlates of protection. Conclusion Vaccination practices for perinatally HIV-infected children vary a great deal between countries. Efforts should be made to improve communication and documentation of vaccinations in healthcare settings and to harmonise recommendations relating to additional vaccines for HIV infected children and the use of laboratory assays to guide immunisation. This will ultimately improve coverage and vaccine induced immunity in this vulnerable patient group.

Published
2016

20. Disease disclosure, treatment adherence, and behavioural profile in a cohort of vertically acquired HIV-infected adolescents. NeuroCoRISpeS study

Author

María Ángeles Muñoz-Fernández, María Isabel González-Tomé, Gabriela Medin, Santiago Jimenez, Sara Guillén, Marisa Navarro Gomez, María José Mellado, Jesus Saavedra, Pablo Rojo Conejo, Cristina García-Navarro, José Tomás Ramos Amador, and Milagros García Hortelano

Subjects
Male, Health Knowledge, Attitudes, Practice, Pediatrics, medicine.medical_specialty, Health (social science), Adolescent, Social Psychology, Cross-sectional study, Social Stigma, HIV Infections, Truth Disclosure, Medication Adherence, Interviews as Topic, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Antiretroviral Therapy, Highly Active, Surveys and Questionnaires, 030225 pediatrics, Adaptation, Psychological, medicine, Humans, 030212 general & internal medicine, Young adult, Child, Psychiatry, business.industry, Public Health, Environmental and Occupational Health, Strengths and Difficulties Questionnaire, Viral Load, Infectious Disease Transmission, Vertical, CD4 Lymphocyte Count, Cross-Sectional Studies, Socioeconomic Factors, Spain, Cohort, Quality of Life, Life expectancy, Female, business, Psychosocial, Viral load
Abstract

Advances in care and antiretroviral treatment, improved life expectancy and quality of life in children with perinatally-acquired human immunodeficiency virus (HIV) infection. There is increasing interest in the chronic effects of growing up with HIV. The aim of this study was to assess the psychosocial, emotional and behavioural functioning in a cohort of perinatally-acquired HIV-infected adolescents. Data were obtained through semi-structured interviews and the Strengths and Difficulties Questionnaire (SDQ) for emotional and behavioural disorders screening.A total of 95 patients (58% women) were assessed with a median age of 15 years (11-19.1) and a median age at diagnosis of 1.7 years (0-12.2). The median CD4 count, at the inclusion, was 626 cells/mm(3) (132-998), with 34% (10-52%). Viral load was50 copies/ml in 72% of patients. Eighty-one per cent knew their diagnosis and optimal adherence was achieved in 53%. Passive coping was reported in 58.4% of the adolescents. Only 7.7% of teenagers had a complete and adequate knowledge of their disease and only 18.2% had shared it with their friends. Six unwanted pregnancies occurred (11% of women). Most of them (90%) attended school but 60% had been held back one or more school years. Overall, SDQ scored a risk of behavioural and emotional problems in 24.5%. The report of behaviours associated with hyperactivity was high in 14.9% of the population and borderline in 18.1%. Adolescents with encephalopathy accounted for 44% of those whose total scores fell in either the abnormal and borderline ranges for emotional difficulties (p = .038).Perinatally-acquired HIV-infected adolescents showed significant psychosocial and behavioural health risks that should bring attention to prevention and health care programmes. An earlier disclosure to children could favour a better psychological adjustment and a better treatment adherence. Future studies are needed to assess the relationship between vertically acquired HIV-infection and hyperactivity.

Published
2015

21. [Experience with infections in the use of extracorporeal membrane oxygenation]

Author

Juan Miguel Aguilar, Sylvia Belda Hofheinz, Alba Palacios Cuesta, Rosa María Calderón Checa, Ana María Llorente de la Fuente, Pablo Rojo Conejo, and Aranzazu Flavia González-Posada Flores

Subjects
Male, endocrine system, medicine.medical_specialty, Demographics, medicine.medical_treatment, Oxigenación por membrana extracorpórea, 030501 epidemiology, Pediatrics, Extracorporeal, RJ1-570, Infección nosocomial, 03 medical and health sciences, Paediatric intensive care unit, 0302 clinical medicine, Extracorporeal Membrane Oxygenation, Management of Technology and Innovation, Coagulopathy, medicine, Extracorporeal membrane oxygenation, Humans, In patient, 030212 general & internal medicine, Paediatric patients, Retrospective Studies, Cross Infection, business.industry, Infant, Newborn, Infant, medicine.disease, Life support, Emergency medicine, Female, 0305 other medical science, business, Factores de riesgo
Abstract

Objective: To identify risk factors associated with infectious complications acquired by paediatric patients during extracorporeal life support (ECLS). Patients and methods: Patients under ECLS from January 2011 to December 2014 have been retrospectively reviewed and data on demographics, care and infectious complications were collected. Results: There were 50 ECLS assistances in the study period, of which 20 patients had 23 infectious complications: 16 were bloodstream infections, with coagulase negative staphylococci being the predominant isolate (there were 2 cases of candidaemia). Age, site of cannulation procedure, cannulation site, severe coagulopathy, and surgical interventions during assistance were analysed as risk factors for infectious complications, but no significant differences were found. ECLS duration was significantly longer in patients with infectious complications (8.91 vs 5.91 days; P = .039). There were no significant differences as regards Paediatric Intensive Care Unit (PICU) stay, or in survival. Conclusions: Infectious complications during ECLS are very common, and ECLS duration is significantly longer in patients with infections. Measures should be put in place to prevent infectious complications and reduce time on ECLS. Resumen: Objetivo: Identificar factores de riesgo asociados con el desarrollo de infecciones nosocomiales en pacientes pediátricos asistidos con oxigenación por membrana extracorpórea (ECMO). Pacientes y métodos: Se han revisado de forma retrospectiva los pacientes que han recibido asistencia en ECMO de enero de 2011 a diciembre de 2014. Se han recogido datos demográficos, sobre la asistencia y sobre las infecciones que aparecen durante dicha asistencia. Resultados: En este periodo hubo 50 asistencias en ECMO. Veinte pacientes tuvieron 23 episodios de infección, de los que 16 fueron bacteriemias, siendo el microorganismo más frecuente el estafilococo coagulasa negativo (habiendo 2 casos de candidemia). En cuanto a los grupos de edad, el lugar y el tipo de canulación, la presencia de coagulopatía grave y la realización de intervenciones quirúrgicas durante la asistencia, ninguno de estos factores resultó un factor de riesgo de infección estadísticamente significativo. La duración media de soporte en ECMO fue significativamente mayor en los pacientes que tuvieron alguna infección (8,91 vs. 5,96 días; p = 0,039). No hubo diferencias significativas en cuanto a la estancia en la Unidad de Cuidados Intensivos Pediátricos ni en cuanto a la supervivencia. Conclusiones: La incidencia de infección durante ECMO es muy alta y los pacientes que tienen una infección están asistidos un tiempo significativamente mayor, por lo que se deben instaurar medidas para prevenir la aparición de estas infecciones e intentar minimizar el tiempo de asistencia en ECMO.

Published
2017

22. Celulitis preseptal y orbitaria

Author

Pablo Rojo Conejo and Isabel Gimeno Sánchez

Subjects
business.industry, Pediatrics, Perinatology and Child Health, Medicine, business
Published
2014

23. Evaluación inicial del programa de prevención de la transmisión materno-infantil de la infección por el virus de la inmunodeficiencia humana en Guinea Ecuatorial

Author

Luis Manuel Prieto-Tato, Pablo Rojo-Conejo, Antonio Vargas-Brizuela, Katie Badillo-Navarro, Jacinta Obiang-Esomoyo, and Pedro Avedillo-Jiménez

Subjects
Microbiology (medical), education.field_of_study, Mother to child transmission, business.industry, Research methodology, Population, Human immunodeficiency virus (HIV), medicine, medicine.disease_cause, business, Hiv transmission, education, Humanities
Abstract

Resumen Introduccion La prevalencia de la infeccion por el virus de la inmunodeficiencia humana (VIH) en gestantes en Guinea Ecuatorial (GE) es alta (7,3%). En 2008 se actualizo el protocolo de prevencion de transmision vertical (PTMH) de VIH para adaptarlo a las guias de la OMS vigentes. El objetivo de nuestro trabajo es describir las caracteristicas y la evolucion de los ninos expuestos al VIH tras la introduccion del protocolo. Metodos Estudio descriptivo retrospectivo de los hijos de madres con infeccion por VIH, en el Hospital Regional y Centro de Salud Maria Rafols en Bata (GE) seguidos desde junio de 2008 hasta noviembre de 2011. El diagnostico de infeccion por VIH en los ninos se baso en el protocolo de test rapidos serologicos. Resultados Se incluyeron 103 ninos, y de ellos 47 eran varones. Un total de 53 pacientes (51%) completaron el seguimiento. Catorce ninos (26%) fueron diagnosticados de infeccion por VIH (11 por diagnostico presuntivo, 3 por persistencia de anticuerpos despues de los 18 meses de vida). Seis ninos (12%) fallecieron antes de un diagnostico definitivo. El 52% de las madres recibieron tratamiento antirretroviral (TAR) durante el embarazo. La transmision vertical en los ninos cuyas madres recibieron TAR fue del 16% (3/19), frente al 43% (10/23) en los ninos cuyas madres no lo recibieron (p = 0,05), y del 8% (1/13) en los ninos cuyas madres recibieron TAR y el nino profilaxis posnatal (p Conclusiones En nuestra cohorte el cumplimiento del protocolo de PTMH ha sido todavia muy bajo. El tratamiento antirretroviral en mujeres embarazadas disminuyo la tasa de transmision vertical, pero esta aun sigue siendo muy alta. Una elevada proporcion de ninos se perdieron durante el seguimiento, asi que es prioritario desarrollar estrategias para evitarlo, asi como medidas de diagnostico virologico precoz.

Published
2014

24. 1958. Antiviral Effects, Pharmacokinetics (PK), and Safety of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678 (JNJ-8678), in RSV-infected Infants With Bronchiolitis, in the Phase 1b Study 53718678RSV1005

Author

Cristina Epalza, Fernando Ferrero, Federico Martinón-Torres, Pablo Rojo Conejo, Bart Remmerie, Sarah Rusch, Katie McFadyen, Eugenio Baraldi, Johan Vingerhoets, Marita Stevens, and Dymphy Huntjens

Subjects
030213 general clinical medicine, viruses, Fusion inhibitor, medicine.disease_cause, Abstracts, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, medicine, 030212 general & internal medicine, Respiratory system, Nose, Respiratory tract infections, business.industry, virus diseases, respiratory system, medicine.disease, Fusion protein, Virology, Infectious Diseases, medicine.anatomical_structure, Respiratory syncytial virus (RSV), B. Poster Abstracts, Oncology, Bronchiolitis, business
Abstract

Background JNJ-8678 is a RSV-specific fusion inhibitor and a potential new treatment for respiratory infections caused by RSV. Data from a Phase 1b study of PK, safety and antiviral effects in hospitalized RSV-infected infants are presented. Methods 37 and 7 patients, respectively, were randomized to JNJ-8678 (ascending doses, Table) or placebo (PBO) treatment once daily for 7 days. PK assessments were based on sparse sampling using a population PK model in adults scaled for pediatrics, accounting for allometric principles and maturation of drug clearance pathways. Safety was evaluated by AE reporting, lab and ECG assessments. Antiviral activity was assessed by measuring viral load (VL) using a quantitative RT-PCR assay for RSV RNA from nasal swabs. Results Sparse PK data are described by an integrated PK model (table) and indicated PK parameters for different dose levels were similar across age groups. Treatment with JNJ-8678 appeared to reduce VL more rapidly than PBO (figure). Median change in VL from baseline (BL) in JNJ-8678-treated patients (combined dose groups) vs. PBO was −1.98 vs. −0.32 log10 copies/mL at Day 3. Mean differences in change from BL (90% CI) of JNJ-8678 (combined dose groups) vs. PBO on Days 2 and 3 were estimated −1.33 (−2.26; −0.39) and −1.62 (−2.55; −0.69) log10 copies/mL, respectively (general linear model, adjusted for BL VL; P ≤ 0.05). There was a clear separation between JNJ-8678 and PBO, but no evident exposure–response relationship. JNJ-8678 was generally well tolerated with no new safety signals compared with adults and no dose relationship with AEs or lab abnormalities were observed. Conclusion This dataset in RSV-infected infants showed a clear trend for an early antiviral effect of JNJ-8678, which was similar across dose groups. JNJ-8678 treatment was generally well tolerated. Table: PK Data by Dose/Age Group Dose Dose (mg/kg) All n = 4 Age (Months) AUC24 Day 7, Mean ± SD Ctrough Day 7, Mean ± SD Low 1 1–3 5,121 ± 471 87 ± 16 1.5 3–6 6,236 ± 578 83 ± 18 2 6–24 5,631 ± 605 39 ± 14 Mid 3 1–3 17,867 ± 1,747 345 ± 64 4.5 3–6 21,965 ± 2,147 346 ± 73 6 6–24 19,693 ± 2,213 170 ± 60 Intermediate 8 6–24 27,454 ± 3,108 256 ± 88 High 5 1–3 32,478 ± 3,194 675 ± 120 6 3–6 30,722 ± 3,015 510 ± 105 9 6–24 31,445 ± 3,565 303 ± 103 Disclosures F. Martinon-Torres, Pfizer: Consultant, Consulting fee. SPMSD: Consultant, Consulting fee. GSK: Consultant, Consulting fee. S. Rusch, Janssen: Employee and Shareholder, Salary. D. Huntjens, Janssen: Employee and Shareholder, Salary. B. Remmerie, Janssen: Employee and Shareholder, Salary. J. Vingerhoets, Janssen: Employee and Shareholder, Salary. K. McFadyen, Janssen: Employee and Shareholder, Salary. E. Baraldi, Abbvie: Lectures, Speaker honorarium. Chiesi Farmaceutici: Consultant, Consulting fee. Novartis: Consultant, Consulting fee. Janssen: Consultant, Consulting fee. M. Stevens, Janssen: Employee and Shareholder, Salary.

Published
2018

25. Bilateral abducens nerve palsy as the initial clinical manifestation of meningococcal meningitis

Author

Rogelio Simón de las Heras, Noemí Núñez Enamorado, Pablo Rojo Conejo, and Ana Camacho Salas

Subjects
03 medical and health sciences, medicine.medical_specialty, 0302 clinical medicine, Palsy, business.industry, 030225 pediatrics, Meningococcal meningitis, Medicine, Clinical manifestation, business, Abducens nerve, 030217 neurology & neurosurgery, Surgery
Published
2017

27. Utilidad clínica de la micafungina en el tratamiento de las candidiasis invasoras en el neonato

Author

María Elena Infante-López and Pablo Rojo-Conejo

Subjects
Infectious Diseases, business.industry, Medicine, business, Microbiology, Humanities
Abstract

Antecedentes: Las infecciones por Candida son un problema clinico importante en las unidades de cuidados intensivos neonatales, no solo por el aumento de su incidencia en grandes prematuros, sino tambien por su alta morbimortalidad, que se mantiene constante a pesar de los avances de los cuidados neonatales en las ultimas decadas. Objetivos: Definir el uso terapeutico de la micafungina en el tratamiento de las candidiasis invasoras neonatales. Metodos: Revisar el estado actual del tratamiento de las candidiasis invasoras en neonatos, en especial la utilidad clinica de la micafungina a partir de los trabajos disponibles en Medline y EMBASE. Resultados y conclusiones: La micafungina es la tercera equinocandina aprobada como agente antifungico. Su amplio espectro de actividad frente a Candida albicans y especies de Candida diferentes a C. albicans, ademas de su escasa interaccion con otros farmacos y poca toxicidad, la convierten en una antifungico atractivo para el tratamiento de las candidiasis invasoras neonatales, una vez descartadas las posibles complicaciones. Debido, en parte, a que hasta el ano 2008 la European Medicines Agency no aprobo el uso de micafungina para el tratamiento de la candidiasis invasora en ninos, la experiencia clinica actual en neonatos es limitada y necesita ampliarse para definir su eficacia y perfil de seguridad.

Published
2009

28. Infecciones neonatales por Staphylococcus aureus de inicio en la comunidad

Author

Pablo Rojo-Conejo, Carmen Gómez-González, Marta Barrios-López, and Fernando Chaves-Sánchez

Subjects
Microbiology (medical)
Abstract

Resumen Introduccion Staphylococcus aureus es una causa importante de infecciones neonatales de inicio en la comunidad. En los ultimos anos se ha notificado en Estados Unidos la emergencia de infecciones por cepas resistentes a la meticilina en este grupo de edad, aunque existen pocos estudios en Espana. El objetivo de este estudio es describir las caracteristicas epidemiologicas, clinicas y microbiologicas de las infecciones por S. aureus de inicio en la comunidad en neonatos. Metodos Estudio prospectivo de las infecciones neonatales por S. aureus de inicio en la comunidad realizado durante 3 anos (2007-2009) en el Servicio de Urgencias Pediatricas del Hospital 12 de Octubre de Madrid (Espana). Resultados Se registraron 30 casos de los que solo un aislado (3,3%) fue resistente a la meticilina y 2 (6,7%) fueron LPV(+). Conclusiones A pesar de la emergencia de SARM y/o productor de LPV fuera del ambiente hospitalario en poblacion pediatrica en Espana, dichas infecciones son todavia poco frecuentes en neonatos.

Published
2013

29. Impact of highly active antiretroviral therapy on the morbidity and mortality in Spanish human immunodeficiency virus-infected children

Author

José Tomás Ramos Amador, Angel Nogales Espert, María Isabel González Tomé, Pablo Rojo Conejo, Paloma Ferrando Vivas, Jesús Ruiz Contreras, Sira FernÁndez De Miguel, JuliÁn Clemente PollÁn, and JosÉ Manuel SÁnchez Granados

Subjects
Male, Microbiology (medical), Pediatrics, medicine.medical_specialty, Anti-HIV Agents, HIV Infections, Risk Assessment, Severity of Illness Index, Drug Administration Schedule, Pharmacotherapy, Acquired immunodeficiency syndrome (AIDS), Reference Values, Antiretroviral Therapy, Highly Active, Cause of Death, Epidemiology, Confidence Intervals, Odds Ratio, medicine, Humans, Probability, Retrospective Studies, Cause of death, Acquired Immunodeficiency Syndrome, Dose-Response Relationship, Drug, business.industry, Incidence (epidemiology), Infant, virus diseases, Retrospective cohort study, Odds ratio, medicine.disease, Survival Analysis, Surgery, Hospitalization, Treatment Outcome, Infectious Diseases, Spain, Child, Preschool, Relative risk, Multivariate Analysis, Pediatrics, Perinatology and Child Health, Disease Progression, HIV-1, Drug Therapy, Combination, Female, business
Abstract

Highly active antiretroviral therapy (HAART) slows the progression of HIV disease and lowers mortality and morbidity in adults. The impact on the disease course in children has not been still completely elucidated. Furthermore the effect of HAART on organ-specific complications of HIV is unknown. To assess the effect of HAART on the progression of HIV infection, mortality, organ-specific complications, number of infections and hospitalizations in HIV-1-infected children. Records of HIV-1-infected children were reviewed in a large referral pediatric hospital. Patients were divided into three groups: children who did not receive antiretroviral therapy (Group 1); children who received mono- or bitherapy (Group 2); and patients who received HAART (Group 3). Endpoints analyzed were progression to AIDS and mortality among AIDS patients and overall. One hundred seven children have been evaluated. Actuarial survival at 5 years of age was 33% in Groups 1 and 2 compared with 100% in Group 3 (P < 0.01). At 5 years of age, the proportion of children progressing to AIDS was 76% in Groups 1 and 2, compared with 26% in Group 3 (P < 0.01). At 5 years of follow-up, there were 45 cases of organ-specific complications in patients without HAART. No children without organ-specific complications when HAART was started have developed them after 5 years (P < 0.01). In patients without HAART there were 9 cases of lymphoid interstitial pneumonia, and there was none in Group 3 (P < 0.01). The incidence rates of infections and hospitalizations were 2.83 and 0.52 per patient-year, respectively, in children who did not receive HAART and 0.75 and 0.17 when they were managed with HAART (relative risk, 0.26 and 0.32). HAART is associated with a marked decline in the progression to AIDS, improved survival in HIV-1-infected children, reduced incidence of infections and hospitalizations and decreased incidence of some organ-specific complications of HIV.

Published
2003

30. Once-daily antiretroviral therapy in a cohort of HIV-infected children and adolescents

Author

M. Isabel de José-Gómez, Miguel A. Roa-Francia, Jorge Martínez-Pérez, M. Luisa Navarro-Gómez, Dolores Gurbindo-Gutierrez, M. Isabel González-Tomé, Jesús Saavedra-Lozano, Beatriz Jiménez-Montero, Santiago Jiménez de Ory, José Beceiro, M. José Mellado-Peña, Pablo Rojo-Conejo, and José Tomás Ramos-Amador

Subjects
Microbiology (medical), Male, Pediatrics, medicine.medical_specialty, Adolescent, business.industry, HIV Infections, Antiretroviral therapy, Medication Adherence, Cohort Studies, Infectious Diseases, Anti-Retroviral Agents, Pill, Hiv infected, Antiretroviral Therapy, Highly Active, Pediatrics, Perinatology and Child Health, Cohort, Medicine, Humans, Female, Once daily, business, Child, Retrospective Studies
Abstract

We evaluated the evolution over time of once-daily antiretroviral therapy in HIV-infected children and its relationship with adherence. An increase on the prevalence of once-daily antiretroviral therapy was observed over time (from 0.9% in 2002 to 44.2% in 2011). There was no difference in adherence regarding once-daily or BID regimens in 2011. Adherence was related to age and pill burden.

Published
2014

31. [Initial evaluation of a programme to prevent mother-to-child transmission of human immunodeficiency virus infection in Equatorial Guinea]

Author

Katie, Badillo-Navarro, Luis, Prieto-Tato, Jacinta, Obiang-Esomoyo, Pedro, Avedillo-Jiménez, Antonio, Vargas-Brizuela, and Pablo, Rojo-Conejo

Subjects
Male, Clinical Protocols, Anti-HIV Agents, Equatorial Guinea, Infant, Newborn, Humans, Infant, Female, HIV Infections, Infectious Disease Transmission, Vertical, Program Evaluation, Retrospective Studies
Abstract

The prevalence of human immunodeficiency virus (HIV)-infected pregnant women in Equatorial Guinea (EG) has been reported as 7.3%. In 2008 an updated version of the PMTCT protocol was accepted according to the current WHO guidelines. The aim of this study was to describe the characteristics and outcome of children exposed to HIV after the introduction of the protocol.A retrospective review was conducted on the clinical characteristics of the infants born to HIV-infected mothers in the Hospital Regional de Bata and Primary Health Care Centre Maria Rafols in Bata (EG) between June 2008 and November 2011. The diagnosis of HIV infection in children was based on rapid serology tests.A total of 103 children were included, of which 47 were males. Fifty three patients (51%) completed the follow-up (51%). Fourteen children (26%) were diagnosed with HIV infection (11 presumptive diagnosis, 3 due to persistence of antibodies at 18 months). Six children (12%) died before a definitive diagnosis. Just over than half (52%) of mothers received antiretroviral therapy (ART) during pregnancy. The transmission rate in children whose mothers received ART was 16% (3/19), compared with 43% (10/23) in children whose mothers did not receive it. Only one child was infected (8%) when the mother received ART, and child received postnatal prophylaxis.The PMTCT protocol compliance was still very low. Antiretroviral therapy in pregnant women decreased the rate of vertical transmission, but the rate still remains very high. Many children were lost to follow-up. Strategies to prevent loss to follow-up and methods for earlier virological diagnostic are needed.

Published
2012

32. [Community-onset Staphylococcus aureus infection in neonates]

Author

Marta, Barrios-López, Pablo, Rojo-Conejo, Carmen, Gómez-González, and Fernando, Chaves-Sánchez

Subjects
Community-Acquired Infections, Methicillin-Resistant Staphylococcus aureus, Infant, Newborn, Humans, Prospective Studies, Staphylococcal Infections
Abstract

Staphylococcus aureus is a major cause of neonatal community-onset infections. The emergence of methicillin-resistant S. aureus infections in this age group has been reported in USA in the last few years; however there are no studies in Spain. The aim of this study is to describe the epidemiological, clinical and microbiological characteristics of S. aureus community-onset infections in neonates.We prospectively reviewed the S. aureus infections in neonates over a three year period (2007-2009) in the Pediatric Emergency Department of Hospital 12 de Octubre in Madrid (Spain).We recorded 30 cases of neonatal S. aureus community-onset infections. Only one isolated (3.3%) was resistant to methicillin, and two (6.7%) were PVL(+).Despite the emergence of MRSA outside the hospital in pediatric population in Spain, CA-MRSA and SA PVL(+) infections are not frequent in neonates.

Published
2012

33. [Micafungin for the treatment of neonatal invasive candidiasis]

Author

María Elena, Infante-López and Pablo, Rojo-Conejo

Subjects
Adult, Male, Clinical Trials as Topic, Antifungal Agents, Adolescent, Age Factors, Candidiasis, Infant, Newborn, Infant, Infant, Premature, Diseases, Echinocandins, Lipopeptides, Meta-Analysis as Topic, Amphotericin B, Child, Preschool, Micafungin, Humans, Multicenter Studies as Topic, Female, Prospective Studies, Child, Fungemia, Infant, Premature, Randomized Controlled Trials as Topic, Retrospective Studies
Abstract

In neonatal intensive care units, deep fungal disease due to Candida spp. are an important clinical problem, partly due to the increasing prevalence of Candida disease and also to the high associated and constant morbimortality; both factors are independently maintained though there has been a significant improvement in the management of neonatal patients.To define the therapeutic use of micafungin for the treatment of neonatal invasive candidiasis.We use a review of biomedic data bases namely Medline and EMBASE.Micafungin is the latest introduced echinocandin. It has a wide spectrum of activity and covers Candida albicans and non-albicans Candida species. It has scarce drugs interactions and is devoid of toxicity, being an attractive approach for the treatment of invasive candidiasis (without meningitis, endocarditis and endophthalmitis). Althought the European Medicines Agency approved in 2008 the use of Micafungin for the treatment of invasive candidiasis in children, the available clinical experience is limited and currently more clinical studies are warranted to define its efficacy and safety in neonates.

Published
2009

37. Chagas disease travels to Europe

Author

Pablo Rojo-Conejo, María Isabel González-Tomé, Luis Ignacio Gonzalez-Granado, and Jesús Ruiz-Contreras

Subjects
Chagas disease, Pregnancy, High prevalence, business.industry, media_common.quotation_subject, Immigration, Prevalence, General Medicine, Disease, medicine.disease, Emigration, Immunology, Life expectancy, Medicine, business, Demography, media_common
Abstract

In his Correspondence letter, Ricardo Pereira Igreja revisits the impor tance of Chagas disease 100 years after its discovery. Immigration from South America to Europe is increasing, so European countries are now facing some neglected diseases they are not used to dealing with. 97·5% of Bolivians who emigrate to Europe (the most popular desti nation after the USA) settle in Spain. The prevalence of Chagas disease in Bolivia is 20–40%. We have been assessing the prevalence of Chagas disease in Bolivian pregnant women in our Spanish hospital for the past 2 years and have found a 17·7% rate (71/401), with a 1·4% vertical transmission rate (1/71). Chagas disease has been included in the routine assessment for LatinAmerican blood donors in Spain since 2005, but no national screening protocol for pregnant woman has been established. Because of the noted high prevalence of Chagas disease in Bolivian pregnant women in Spain, we suggest that all such women should be screened. Early treatment of infected children could avoid most of the severe complications associated with this disease. Furthermore, identifi cation of the mothers would allow treatment of this group and could off er them a better life expectancy.

Published
2009

38. CD4/CD8 Ratio and the Risk of Kaposi Sarcoma or Non-Hodgkin Lymphoma in the Context of Efficiently Treated Human Immunodeficiency Virus (HIV) Infection: A Collaborative Analysis of 20 European Cohort Studies

Author

Caby, F., Guiguet, M., Weiss, L., Winston, A. d., Miro, J. M., Konopnicki, D., Le Moing, V., Bonnet, F. h., Reiss, P., Mussini, C., Poizot-Martin, I., Taylor, N. l., Skoutelis, A., Meyer, L., Goujard, C., Bartmeyer, B., Boesecke, C., Antinori, A., Quiros-Roldan, E., Wittkop, L., Frederiksen, C., Castagna, A., Thurnheer, M. C., Svedhem, V., Jose, S., Costagliola, D., Mary-Krause, M., Grabar, S., Judd, A., Zangerle, R., Touloumi, G., Warszawski, J., Dabis, F., Krause, M. M., Ghosn, J., Leport, C., Wit, F., Prins, M., Bucher, H., Gibb, D., Fätkenheuer, G., Del Amo, J., Obel, N., Thorne, C., Mocroft, A., Kirk, O., Stephan, C., Pérez-Hoyos, S., Hamouda, O., Chkhartishvili, N., Noguera-Julian, A., Monforte, A. D., Brockmeyer, N., Prieto, L., Conejo, P. R., Soriano-Arandes, A., Battegay, M., Kouyos, R., Casabona, J., Miró, J. M., Konopnick, D., Goetghebuer, T., Sönnerborg, A., Torti, C., Sabin, C., Teira, R., Garrido, M., Haerry, D., Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Victor Dupouy, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Imperial College London, University of Barcelona, Université libre de Bruxelles (ULB), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], University of Amsterdam [Amsterdam] (UvA), Università degli Studi di Modena e Reggio Emilia = University of Modena and Reggio Emilia (UNIMORE), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU), Evangelismos Athens General Hospital, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Hôpital Bicêtre, Robert Koch Institute [Berlin] (RKI), University Hospital Bonn, National Institute for Infectious Diseases 'Lazzaro Spallanzani', Università degli Studi di Brescia = University of Brescia (UniBs), Team MORPH3EUS (INSERM U1219 - UB - ISPED), University of Copenhagen = Københavns Universitet (UCPH), IRCCS Ospedale San Raffaele [Milan, Italy], Bern University Hospital [Berne] (Inselspital), Karolinska Institutet [Stockholm], Public Health England [London], Hôpital Cochin [AP-HP], Agence Nationale de Recherches sur le Sida et les Hépatites Virales, (CD4/CD8 ratio and cancer risk) project Working Group for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) in EuroCoord: Ali Judd, Robert Zangerle, Giota Touloumi, Josiane Warszawski, Laurence Meyer, François Dabis, Murielle Mary Krause, Jade Ghosn, Catherine Leport, Linda Wittkop, Peter Reiss, Ferdinand Wit, Maria Prins, Heiner Bucher, Diana Gibb, Gerd Fätkenheuer, Julia Del Amo, Niels Obel, Claire Thorne, Amanda Mocroft, Ole Kirk, Christoph Stephan, Santiago Pérez-Hoyos, Osamah Hamouda, Barbara Bartmeyer, Nikoloz Chkhartishvili, Antoni Noguera-Julian, Andrea Antinori, Antonella d'Arminio Monforte, Norbert Brockmeyer, Luis Prieto, Pablo Rojo Conejo, Antoni Soriano-Arandes, Manuel Battegay, Roger Kouyos, Cristina Mussini, Jordi Casabona, Jose M Miró, Antonella Castagna, Deborah Konopnick, Tessa Goetghebuer, Anders Sönnerborg, Carlo Torti, Caroline Sabin, Ramon Teira, Myriam Garrido, David Haerry, European Project: 287519, European Project: 260694,EC:FP7:HEALTH,FP7-HEALTH-2010-single-stage,EUROCOORD(2011), Admin, Oskar, European Union Seventh Framework Programme - 287519 - INCOMING, European Network of HIV/AIDS Cohort Studies to Coordinate at European and International Level Clinical Research on HIV/AIDS - EUROCOORD - - EC:FP7:HEALTH2011-01-01 - 2015-12-31 - 260694 - VALID, Caby, Fabienne, Guiguet, Marguerite, Weiss, Laurence, Winston, Alan, Miro, Jose M, Konopnicki, Deborah, Le Moing, Vincent, Bonnet, Fabrice, Reiss, Peter, Mussini, Cristina, Poizot-Martin, Isabelle, Taylor, Ninon, Skoutelis, Athanasio, Meyer, Laurence, Goujard, Cécile, Bartmeyer, Barbara, Boesecke, Christoph, Antinori, Andrea, Quiros-Roldan, Eugenia, Wittkop, Linda, Frederiksen, Casper, Castagna, Antonella, Thurnheer, Maria Christine, Svedhem, Veronica, Jose, Sophie, Costagliola, Dominique, Mary-Krause, Murielle, Grabar, Sophie, Global Health, Infectious diseases, AII - Infectious diseases, and APH - Aging & Later Life

Subjects
CD4/CD8 ratio, CD8 T-cells, Kaposi sarcoma, efficient cART, non-Hodgkin lymphoma, 0301 basic medicine, Microbiology (medical), Lymphoma, [SDV]Life Sciences [q-bio], 030106 microbiology, CD4-CD8 Ratio, Non-Hodgkin, HIV Infections, Kaposi, Efficient cART, Drug resistance, HIV superinfection, CD8-Positive T-Lymphocytes, medicine.disease_cause, Men who have sex with men, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, CD4 Lymphocyte Count, HIV, Humans, Incidence, Risk Factors, Lymphoma, Non-Hodgkin, Sarcoma, Kaposi, immune system diseases, Medicine, 030212 general & internal medicine, Non-Hodgkin lymphoma, Transmission (medicine), business.industry, Sarcoma, Resistance mutation, 3. Good health, Infectious Diseases, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Superinfection, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Viral load, HIV drug resistance, Demography
Abstract

BackgroundA persistently low CD4/CD8 ratio has been reported to inversely correlate with the risk of non-AIDS defining cancer in people living with human immunodeficiency virus (HIV; PLWH) efficiently treated by combination antiretroviral therapy (cART). We evaluated the impact of the CD4/CD8 ratio on the risk of Kaposi sarcoma (KS) or non-Hodgkin lymphoma (NHL), still among the most frequent cancers in treated PLWH.MethodsPLWH from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) were included if they achieved virological control (viral load ≤ 500 copies/mL) within 9 months following cART and without previous KS/LNH diagnosis. Cox models were used to identify factors associated with KS or NHL risk, in all participants and those with CD4 ≥ 500/mm3 at virological control. We analyzed the CD4/CD8 ratio, CD4 count and CD8 count as time-dependent variables, using spline transformations.ResultsWe included 56 708 PLWH, enrolled between 2000 and 2014. At virological control, the median (interquartile range [IQR]) CD4 count, CD8 count, and CD4/CD8 ratio were 414 (296–552)/mm3, 936 (670–1304)/mm3, and 0.43 (0.28–0.65), respectively. Overall, 221 KS and 187 NHL were diagnosed 9 (2–37) and 18 (7–42) months after virological control. Low CD4/CD8 ratios were associated with KS risk (hazard ratio [HR] = 2.02 [95% confidence interval {CI } = 1.23–3.31]) when comparing CD4/CD8 = 0.3 to CD4/CD8 = 1) but not with NHL risk. High CD8 counts were associated with higher NHL risk (HR = 3.14 [95% CI = 1.58–6.22]) when comparing CD8 = 3000/mm3 to CD8 = 1000/mm3). Similar results with increased associations were found in PLWH with CD4 ≥ 500/mm3 at virological control (HR = 3.27 [95% CI = 1.60–6.56] for KS; HR = 5.28 [95% CI = 2.17–12.83] for NHL).ConclusionsLow CD4/CD8 ratios and high CD8 counts despite effective cART were associated with increased KS/NHL risks respectively, especially when CD4 ≥ 500/mm3.

Published
2021

39. ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

Author

Clare Shakeshaft, Carlo Giaquinto, Tim R. Cressey, Adeodata Kekitiinwa, David M. Burger, Pauline Amuge, Pablo Rojo, Cecilia L. Moore, Osee Behuhuma, Yacine Saϊdi, Linda Barlow-Mosha, James Hakim, Alexandra Compagnucci, Lorna Atwine, Diana M. Gibb, Ebrahim Variava, Hilda Mujuru, Mark F. Cotton, Victor Musiime, Moherndran Archary, Deborah Ford, Cissy Kityo, Thanyawee Puthanakit, Anna Turkova, Avy Violari, Abbas Lugemwa, Medical Research Council Clinical Trials Unit (MRC CTU), University College of London [London] (UCL), University of Zimbabwe (UZ), Baylor College of Medicine Children's Foundation [Kampala, Uganda] (BCMCF), Joint Clinical Research Centre, MUJHU Research Collaboration [Kampala, Uganda] (MUJHURC), Chiang Mai University (CMU), Harvard T.H. Chan School of Public Health, University of Liverpool, Perinatal HIV Research Unit [Johannesburg, South Africa] (PHRU), University of the Witwatersrand [Johannesburg] (WITS), Klerksdorp Tshepong Hospital Complex [Matlosana, South Africa] (KTHC), Family Center for Research with Ubuntu [Cape Town, South Africa] (FCRU), Durban International Clinical Research Site [Durban, South Africa] (DICRS), Essais Thérapeutiques et Maladies Infectieuses, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Chulalongkorn University [Bangkok], Africa Health Research Institute [Hlabisa, South Africa] (AHRI), Hlabisa Hospital [Hlabisa, South Africa] (HH), Radboud University Medical Center [Nijmegen], Università degli Studi di Padova = University of Padua (Unipd), Hospital Universitario 12 de Octubre [Madrid], ODYSSEY Trial Team: Shabinah Ali, Abdel Babiker, Chiara Borg, Anne-Marie Borges Da Silva, Joanna Calvert, Deborah Ford, Joshua Gasa, Diana M Gibb, Nasir Jamil, Sarah Lensen, Emma Little, Fatima Mohamed, Samuel Montero, Cecilia L Moore, Rachel Oguntimehin, Anna Parker, Reena Patel, Tasmin Phillips, Tatiana Sarfati, Karen Scott, Clare Shakeshaft, Moira Spyer, Margaret Thomason, Anna Turkova, Rebecca Turner, Nadine Van Looy, Ellen White, Kaya Widuch, Helen Wilkes, Ben Wynne, Carlo Giaquinto, Tiziana Grossele, Daniel Gomez-Pena, Davide Bilardi, Giulio Vecchia, Alexandra Compagnucci, Yacine Saidi, Yoann Riault, Alexandra Coelho, Laura Picault, Christelle Kouakam, Tim R Cressey, Suwalai Chalermpantmetagul, Dujrudee Chinwong, Gonzague Jourdain, Rukchanok Peongjakta, Pra-Ornsuda Sukrakanchana, Wasna Sirirungsi, Janet Seeley, Sarah Bernays, Magda Conway, Nigel Klein, Eleni Nastouli, Anita De Rossi, Maria Angeles Munoz Fernandez, David Burger, Pauline Bollen, Angela Colbers, Hylke Waalewijn, Cissy M Kityo, Victor Musiime, Elizabeth Kaudha, Annet Nanduudu, Emmanuel Mujyambere, Paul Ocitti Labeja, Charity Nankunda, Juliet Ategeka, Peter Erim, Collin Makanga, Esther Nambi, Abbas Lugemwa, Lorna Atwine, Edridah Keminyeto, Deogratiuos Tukwasibwe, Shafic Makumbi, Emily Ninsiima, Mercy Tukamushaba, Rogers Ankunda, Ian Natuhurira, Miriam Kasozi, Baker Rubinga, Adeodata R Kekitiinwa, Pauline Amuge, Dickson Bbuye, Justine Nalubwama, Winnie Akobye, Muzamil Nsibuka Kisekka, Anthony Kirabira, Gloria Ninsiima, Sylvia Namanda, Gerald Agaba, Immaculate Nagawa, Annet Nalugo, Florence Namuli, Rose Kadhuba, Rachael Namuddu, Lameck Kiyimba, Angella Baita, Eunice Atim, Olivia Kobusingye, Clementine Namajja, Africanus Byaruhanga, Rogers Besigye, Herbert Murungi, Geoffrey Onen, Philippa Musoke, Linda Barlow-Mosha, Grace Ahimbisibwe, Rose Namwanje, Monica Etima, Mark Ssenyonga, Robert Serunjogi, Hajira Kataike, Richard Isabirye, David Balamusani, Monica Nolan, Mark F Cotton, Anita Janese van Rensburg, Marlize Smuts, Catherine Andrea, Sumaya Dadan Sonja Pieterse, Vinesh Jaeven, Candice Makola, George Fourie, Kurt Smith, Els Dobbels, Peter Zuidewind, Hesti Van Huyssteen, Mornay Isaacs, Georgina Nentsa, Thabis Ncgaba, Candice MacDonald, Mandisa Mtshagi, Maria Bester, Wilma Orange, Ronelle Arendze, Mark Mulder, George Fourie, Avy Violari, Nastassja Ramsagar, Afaaf Liberty, Ruth Mathiba, Lindiwe Maseko, Nakata Kekane, Busi Khumlo, Mirriam Khunene, Noshalaza Sbisi, Jackie Brown, Ryphina Madonsela, Nokuthula Mbadaliga, Zaakirah Essack, Reshma Lakha, Aasia Vadee, Derusha Frank, Nazim Akoojee, Maletsatsi Monametsi, Gladness Machache, Yolandie Fourie, Anusha Nanan-Kanjee, Juan Erasmus, Angelous Mamiane, Tseleng Daniel, Fatima Mayat, Nomfundo Maduna, Patsy Baliram, Chaiwat Ngampiyasakul, Pisut Greetanukroh, Wanna Chamjamrat, Praechadaporn Khannak, Pornchai Techakunakorn, Thitiwat Thapwai, Patcharee Puangmalai, Ampai Maneekaew, Pradthana Ounchanum, Yupawan Thaweesombat, Areerat Kongponoi, Jutarat Thewsoongnoen, Suparat Kanjanavanit, Pacharaporn Yingyong, Thida Namwong, Rangwit Junkaew, Ussanee Srirompotong, Patamawadee Sudsaard, Siripun Nuanbuddee, Sookpanee Wimonklang, Sathaporn Na-Rajsima, Suchart Thongpaen, Pattira Runarassamee, Watchara Meethaisong, Arttasid Udomvised, Ebrahim Variava, Modiehi Rakgokong, Dihedile Scheppers, Tumelo Moloantoa, Abdul Hamid Kaka, Tshepiso Masienyane, Akshmi Ori, Kgosimang Mmolawa, Pattamukkil Abraham, Moherndran Archary, Rejoice Mosia, Sajeeda Mawlana, Rosie Mngqibisa, Rashina Nundlal, Elishka Singh, Penelope Madlala, Allemah Naidoo, Sphiwee Cebekhulu, Petronelle Casey, Collin Pillay, Subashinie Sidhoo, Minenhle Chikowore, Lungile Nyantsa, Melisha Nunkoo, Terence Nair, Enbavani Pillay, Sheleika Singh, Sheroma Rajkumar, Osee Behuhuma, Olivier Koole, Kristien Bird, Nomzamo Buthelezi, Mumsy Mthethwa, James Hakim, Hilda Mujuru, Kusum Nathoo, Mutsa Bwakura-Dangarembizi, Ennie Chidziva, Shepherd Mudzingwa, Themelihle Bafana, Colin Warambwa, Godfrey Musoro, Gloria Tinago, Shirley Mutsai, Columbus Moyo, Ruth Nhema, Misheck Nkalo Phiri, Stuart Chitongo, Joshua Choga, Joyline Bhiri, Wilber Ishemunyoro, Makhosonke Ndlovu, Thanyawee Puthanakit, Naruporn Kasipong, Sararut Chanthaburanun, Kesdao Nanthapisal, Thidarat Jupimai, Thornthun Noppakaorattanamanee, Torsak Bunupuradah, Wipaporn Natalie Songtaweesin, Chutima Saisaengjan, Stephan Schultze-Straber, Christoph Konigs, Robin Kobbe, Felicia Mantkowski, Steve Welch, Jacqui Daglish, Laura Thrasyvoulou, Delane Singadia, Sophie Foxall, Judith Acero, Gosia Pasko-Szcech, Jacquie Flynn, Gareth Tudor-Williams, Farhana Abdulla, Srini Bandi, Jin Li, Sean O'Riordan, Dominique Barker, Richard Vowden, Colin Ball Eniola Nsirim, Kathleen McClughlin, India Garcia, Pablo Rojo Conejo, Cristina Epalza, Luis Prieto Tato, Maite Fernandez, Luis Escosa Garcia, Maria José Mellado Peña, Talia Sainz Costa, Claudia Fortuny Guasch, Antoni Noguera Julian, Carolina Estepa, Elena Bruno, Alba Murciano Cabeza, Maria Angeles Muñoz Fernandez, Paula Palau, Laura Marques, Carla Teixeira, Alexandre Fernandes, Rosita Nunes, Helena Nascimento, Andreia Padrao, Joana Tuna, Helena Ramos, Ana Constança Mendes, Helena Pinheiro, Ana Cristina Matos, Flavia Kyomuhendo, Sarah Nakalanzi, Cynthia Mukisa Williams, Ntombenhle Ngcobo, Deborah Pako, Jacky Crisp, Benedictor Dube, Precious Chandiwana, Winnie Gozhora, Ian Weller, Elaine Abrams, Tsitsi Apollo, Polly Clayden, Valériane Leroy, Anton Pozniak, Jane Crawley, Rodolphe Thiébaut, Helen McIlleron, Alasdair Bamford, Hermione Lyall, Andrew Prendergast, Felicity Fitzgerald, Anna Goodman, Malbec, Odile, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Radboud University Medical Centre [Nijmegen, The Netherlands], and Universita degli Studi di Padova

Subjects
0301 basic medicine, Male, Pediatrics, [SDV]Life Sciences [q-bio], HIV Infections, Basket trial, Dolutegravir, Efficacy, HIV, Paediatric, Pharmacokinetic, Randomized control trial, Safety, Adolescent, Body Weight, Child, Child, Preschool, Cohort Studies, Drug Dosage Calculations, Europe, Female, HIV Integrase Inhibitors, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Oxazines, Piperazines, Pyridones, RNA, Viral, South Africa, Thailand, Treatment Outcome, Uganda, Viral Load, World Health Organization, Zimbabwe, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Heterocyclic Compounds, law, Clinical endpoint, Medicine, Viral, 030212 general & internal medicine, 3. Good health, [SDV] Life Sciences [q-bio], Infectious Diseases, Viral load, Cohort study, Research Article, medicine.medical_specialty, 030106 microbiology, 3-Ring, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, lcsh:RC109-216, Dosing, Preschool, Pregnancy, business.industry, Clinical study design, medicine.disease, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], chemistry, RNA, business
Abstract

Background Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in children and adolescents. The ODYSSEY trial includes nested pharmacokinetic (PK) sub-studies which evaluated pragmatic World Health Organization (WHO) weight-band-based DTG dosing and opened recruitment to children Methods ODYSSEY (Once-daily DTG based ART in Young people vS. Standard thErapY) is an open-label, randomised, non-inferiority, basket trial comparing the efficacy and safety of DTG + 2 nucleos(t) ides (NRTIs) versus standard-of-care (SOC) in HIV-infected children Results Between September 2016 and June 2018, 707 children weighing ≥14 kg were enrolled; including 311 ART-naïve children and 396 children starting second-line. 47% of children were enrolled in Uganda, 21% Zimbabwe, 20% South Africa, 9% Thailand, 4% Europe. 362 (51%) participants were male; median age [range] at enrolment was 12.2 years [2.9–18.0]. 82 (12%) children weighed 14 to Conclusions By employing a basket design, to include ART-naïve and -experienced children, and nested PK sub-studies, the ODYSSEY trial efficiently evaluates multiple scientific questions regarding dosing and effectiveness of DTG-based ART in children. Trial registration NCT, NCT02259127, registered 7th October 2014; EUDRACT, 2014–002632-14, registered 18th June 2014 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002632-14/ES); ISRCTN, ISRCTN91737921, registered 4th October 2014.

Published
2021

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