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

Author

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

Published
2022
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3. Extended pre-exposure prophylaxis with lopinavir–ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial

Author

Van de Perre, Philippe, Nagot, Nicolas, Vallo, Roselyne, Marechal, Valerie, Peries, Marianne, Neveu, Dorine, Foulongne, Vincent, Segondy, Michel, Blanche, Stephane, Treluyer, Jean-Marc, Hirt, Deborah, Tumwine, James K, Ndeezi, Grace, Karamagi, Charles, Musoke, Philippa, Mugaba, Proscovia M, Kwagala, Mary, Murungi, Joan, Muweesi, Hawa Nabuuma, Ninsiima, Evelyn, Baryeija, Simon, Juma, Frederic, Kata, Caleb Bwengye, Katushabe, Stuart, Meda, Nicolas, Ouédraogo, Rasmata, Yé, Diarra, Somé, Eric, Traoré, Hugues A, Nadembega, Christelle, Konaté, Justin, Zongo, Arsène, Ouédraogo, Abass, Néboua, Désiré, Bélemviré, Aissatou, Bambara, Armel, Boncoungou, Justine, Zoungrana, Danielle, Nikodem, Cheryl, Hofmeyr, Justus, Harper, Kim, Jackson, Debra, Sanders, David, Singata, Mandisa, Aku, Amwe, Okegbe-Eze, Collins, Williams, Xoliswa, Mshweshwe, Nolundi, Henge, Vatiswa, Gomba, Fikiswa, Gundu, Tapiwa, Khondowe, Oswell, Kankasa, Chipepo, Mwiya, Mwiya, Lusaka, Mildred, Chizyuka, Mary, Phiri, Mary, Imakando, Billies, Musaku, Mwenechanya, Kapasa, Monica, Rutagwera, David, Clement, Gondwe, Mwaba, Hilton Mwila, Matoba, Japhet, Siuluta, Chafye, Chola, Katai, Mwamutanda, Patricia, Tylleskär, Thorkild, Sommerfelt, Halvor, Engebretsen, Ingunn, Klungsøyr, Jørn, van den Broeck, Jan, Blume, Jörn, Rekacewicz, Claire, Hofmeyr, G Justus, Traore, Hugues, Sunday, Amwe, Some, Eric, Neboua, Desire, Maréchal, Valérie, Engebretsen, Ingunn M S, Lombard, Carl, and Blanche, Stéphane

Published
2016
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6. What babies need: accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies

Author

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

Published
2022
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7. Lopinavir/Ritonavir Monotherapy as a Nucleoside Analogue—Sparing Strategy to Prevent HIV-1 Mother-to-Child Transmission: The ANRS 135 PRIMEVA Phase 2/3 Randomized Trial

Author

ANRS 135 PRIMEVA (Protease Inhibitor Monotherapy Evaluation) Study Group, Tubiana, Roland, Mandelbrot, Laurent, Le Chenadec, Jérome, Delmas, Sandrine, Rouzioux, Christine, Hirt, Deborah, Treluyer, Jean-Marc, Ekoukou, Dieudonné, Bui, Eda, Chaix, Marie-Laure, Blanche, Stéphane, and Warszawski, Josiane

Published
2013
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9. Oral levofloxacin: population pharmacokinetics model and pharmacodynamics study in bone and joint infections

Author

Canouï, Etienne, primary, Kerneis, Solen, additional, Morand, Philippe, additional, Enser, Maya, additional, Gauzit, Rémy, additional, Eyrolle, Luc, additional, Leclerc, Philippe, additional, Contejean, Adrien, additional, Zheng, Yi, additional, Anract, Philippe, additional, Hirt, Deborah, additional, Treluyer, Jean Marc, additional, Bouazza, Naim, additional, and Benaboud, Sihem, additional

Published
2022
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10. High nevirapine levels in breast milk and consequences in HIV-infected child when initiated on antiretroviral therapy

Author

PRESSIAT, Claire, TONI, Thomas D'Aquin, TRELUYER, Jean Marc, YONABA, Caroline, DAHOUROU, Desire Lucien, MALATESTE, Karen, SEGUIN-DEVAUX, Carole, LEROY, Valeriane, HIRT, Deborah, and GROUP, Monod Anrs Study

Subjects
Pediatrics, medicine.medical_specialty, Nevirapine, Milk, Human, Anti-HIV Agents, business.industry, Immunology, HIV Infections, Breast milk, Antiretroviral therapy, Infectious Disease Transmission, Vertical, Infectious Diseases, Hiv infected, Humans, Immunology and Allergy, Medicine, Female, Child, business, medicine.drug
Published
2021

13. Retention of Plasmodium falciparum ring-infected erythrocytes in the slow, open microcirculation of the human spleen

Author

Safeukui, Innocent, Correas, Jean-Michel, Brousse, Valentine, Hirt, Déborah, Deplaine, Guillaume, Mulé, Sébastien, Lesurtel, Mickael, Goasguen, Nicolas, Sauvanet, Alain, Couvelard, Anne, Kerneis, Sophie, Khun, Huot, Vigan-Womas, Inès, Ottone, Catherine, Molina, Thierry Jo, Tréluyer, Jean-Marc, Mercereau-Puijalon, Odile, Milon, Geneviève, David, Peter H., and Buffet, Pierre A.

Published
2008
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14. Pharmacology and immuno-virologic efficacy of once-a-day HAART in African HIV-infected children: ANRS 12103 phase II trial/Pharmacologie et efficacite immunovirologique d'un TAHA en prise quotidienne chez des enfants africains infectes par le VIH: essai ANRS 12103 phase II/Farmacologia y eficacia inmunovirologica de HAART diario en ninos africanos infectados por VIH: ensayo

Author

Nacro, Boubacar, Zoure, Emmanuelle, Hien, Herve, Tamboura, Hassane, Rouet, Francois, Ouiminga, Adama, Drabo, Ali, Yameogo, Souleymane, Hien, Alain, Peyriere, Helene, Mathieu, Olivier, Hirt, Deborah, Treluyer, Jean-Marc, Nicolas, Joelle, Foulongne, Vincent, Segondy, Michel, van de Perre, Philippe, Diagbouga, Serge, and Msellati, Philippe

Subjects
Epivir (Medication), Diseases, Analysis, Product development, Algorithm, Clinical trials -- Analysis, Bacterial infections -- Analysis, Lymphocytes -- Analysis, Highly active antiretroviral therapy -- Analysis, Child development -- Analysis, Pediatric diseases -- Analysis, Child health -- Analysis, DNA polymerases -- Analysis, Proteases -- Product development -- Analysis, Aspartate -- Product development -- Analysis, RNA -- Analysis, Biological products industry -- Product development -- Analysis, Algorithms -- Analysis, Lamivudine -- Product development -- Analysis, HIV infections -- Analysis, Disease transmission -- Analysis, Children -- Analysis, Pediatric pharmacology -- Analysis, Liquid chromatography -- Analysis, HIV -- Analysis, Antacids -- Product development -- Analysis, Children -- Analysis -- Diseases -- Health aspects, HIV (Viruses) -- Analysis, HIV infection -- Analysis
Abstract

Introduction Worldwide, over two million children are infected by human immunodeficiency virus type l (HIV-1). (1) Ninety per cent of them live in Africa, and only 38% of those who [...], Objective To assess 12-month survival, pharmacokinetics, immunologic and virologic efficacy, tolerance, compliance and drug resistance in HIV-infected children in Bobo-Dioulasso, Burkina Faso, receiving once-daily highly-active antiretroviral therapy as a combination of didanosine (DDI), lamivudine (3TC) and efavirenz (EFV). Methods In the ANRS 12103 open phase II trial, HIV-infected children were examined at inclusion and monthly thereafter. CD4+ T-lymphocyte (CD4) count, plasma concentration of ribonucleic acid (RNA) of human immunodeficiency virus type 1 (HIM-1) and haematologic and biochemical parameters were measured at baseline and every trimester. HIV-1 resistance testing was performed in case of viral escape. Drug plasma concentrations were determined with high-performance liquid chromatography. Findings From February 2006 to November 2007, 51 children (39% girls) with a mean age of 6.8 years were enrolled and treated for 12 months. At baseline, Z scores for mean weight-for-age and mean height-for-age were -2.01 and -2.12, respectively. Mean CD4% was 9.0. Median plasma HIV-1 RNA viral load was 5.51 [log.sub.10] copies per millilitre (cp/ml). Two children (3.9%) died and another 11 (22%) suffered 13 severe clinical events. At month 12, mean WAZ had improved by 0.63 (P< 0.001) and mean HAZ by 0.57 (P< 0.001). Mean CD4% had risen to 24 (P< 0.001). Viral load was below 300 RNA cp/ml in 81% of the children; HIV resistance mutations were detected in 11 (21.6%). Conclusion The once-a-day combination of DDI + 3TC + EFV is an alternative first-line treatment for HIV-1-infected children. Dose adjustment should further improve efficacy. Objectif Evaluer sur 12 mois la survie, la pharmacocinetique, l'efficacite immunologique et virologique, la tolerance, l'observance et la resistance au medicament chez des enfants infectes par le VlH a Bobo-Dioulasso, Burkina Faso, et qui recoivent une fois par jour une therapie antiretrovirale hautement active par une association de didanosine (DDI), de lamivudine (3TC) et d'efavirenz (EFV). Methodes Dans l'essai ouvert ANRS 12103 phase II, des enfants infectes par le VlH ont ete examines au moment de l'inclusion et ensuite chaque mois. Le taux de lymphocytes T CD4 (CD4), la concentration plasmatique d'acide ribonucleique (ARN) du virus de l'immunodeficience humaine type 1 (VlH-1), ainsi que des parametres hematologiques et biochimiques ont ete mesures au debut de l'etude et chaque trimesb'e. Le test de resistance au VIH-1 a ete effectue dans les cas d'evasion virale. Les concentrations plasmatiques de medicament ont ete determinees par chromatographie liquide a haute performance. Resultats De fevrier 2006 a novembre 2007, 51 enfants (39% de filles), avec une moyenne d'age de 6,8 ans, ont ete selectionnes et traites pendant 12 mois. Au debut de l'etude, les ecarts reduits pour le poids moyen par age et la taille moyenne par age etaient respectivement de -2,01 et -2,12. Le CD4 moyen etait 9,0%. La charge virale plasmatique mediane de I'ANR VIH-1 etait de 5,51 legue copies par millilitre (cp/ ml). Deux enfants (3,9%) sont decedes et 11 autres (22%) ont souffert 13 evenements cliniques severes. Au 12e mois, le WAZ moyen s'etait ameliore de 0,63 (P Conclusion L'association DDI + 3TC + EFV en une prise quotidienne est un traitement alternatif de premiere intention pour les enfants infectes au VIH-1. L'adaptation de la dose devrait encore ameliorer l'efficacite. Objetivo Evaluar a 12 meses la supervivencia, la farmacocinetica, la eficacia inmunologica y virologica, la tolerancia, el cumplimiento terapeutico y la resistencia a los medicamentos en ninos infectados con el VIH en Bobo-Dioulasso (Burkina Faso), que reciben una vez al dia un tratamiento antirretrovirico muy activo, constituido por la asociacion de didanosina (DDI), lamivudina (3TC) y efavirenz (EFV). Metodos En el ensayo clinico ANRS 12103, abierto y de fase II, se examino a los ninos infectados con el VIH en el momento de la inclusion y, a continuacion, mensualmente. Se midieron el recuento de linfocitos T [CD4.sup.+] (CD4), la concentracion plasmatica de acido ribonucleico (ARN) del virus de la inmunodeficiencia humana de tipo 1 (VlH-1) y los parametros hematologicos y bioquimicos, al inicio y cada trimestre. Las pruebas de resistencia al VIH-1 se realizaron en el caso de escape virico. Las concentraciones plasmaticas del farmaco se determinaron con cromatografia en fase liquida de alta resolucion. Resultados Desde febrero del 2006 a noviembre del 2007, 51 ninos (39% ninas) con una edad media de 6,8 anos fueron registrados y tratados durante 12 meses. Al inicio del estudio, las puntuaciones Z del peso medio por edad y la altura media por edad fueron -2,01 y -2,12 respectivamente. El % medio de CD4 fue 9,0. La carga virica media de RNA del HIV-1 en plasma fue de 5,51 [log.sub.10] copias por mililitro (cp/ml). Dos ninos (3,9%) murieron y otros 11 (22%) sufrieron 13 acontecimientos clinicos graves. En el mes 12, el WAZ medio (peso por edad segun la puntuacion Z) habia mejorado en un 0,63 (p < 0,001) y el HAZ medio (altura por edad segun la puntuacion Z) en 0,57 (p < 0,001). El % medio de CD4 habia subido a 24 (p < 0,001). La carga virica estaba por debajo de 300 ARN cp/ml en el 81% de los ninos; se detectaron mutaciones de resistencia al VlH en 11 (21,6%). Conclusion La asociacion de DDI + 3TC + EFV una vez al dia es un tratamiento alternativo de primera linea para los ninos infectados con el VIH-1. Un ajuste de la dosis deberia mejorar todavia mas la eficacia.

Published
2011
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16. Blood concentrations are better predictors of chioroquine poisoning severity than plasma concentrations: a prospective study with modeling of the concentration/effect relationships

Author

Megarbane, Bruno, Bloch, Vanessa, Hirt, Deborah, Debray, Marcel, Resiere, Dabor, Deye, Nicolas, and Baud, Frederic J.

Subjects
Chloroquine -- Complications and side effects, Cardiovascular diseases -- Risk factors, Cardiovascular diseases -- Prognosis, Blood plasma -- Analysis, Drugs -- Health aspects, Drugs -- Diagnosis, Drugs -- Research, Environmental issues, Health, Pharmaceuticals and cosmetics industries
Published
2010

19. Changes in body mass index and hemoglobin concentration in breastfeeding women living with HIV with a CD4 count over 350: Results from 4 African countries (The ANRS 12174 trial)

Author

Somé, Eric, Engebretsen, Ingunn Marie S., Nagot, Nicolas, Meda, Nicolas Y, Vallo, Roselyne, Kankasa, Chipepo, Tumwine, James K, Singata, Mandisa, Hofmeyr, Justus G, Van De Perre, Philippe, Tylleskär, Thorkild, Marechal, Valerie, Neveu, Dorine, Foulongne, Vincent, Segondy, Michel, Schaub, Roxanne, Blanche, Stephane, Treluyer, Jean-Marc, Hirt, Deborah, Karamagi, Charles, Musoke, Philippa, Ndeezi, Grace, Mugaba, Proscovia M, Kwagala, Mary, Murungi, Joan, Muweesi, Hawa Nabuuma, Ninsiima, Evelyn, Baryeija, Simon, Ouedraogo, Rasmata, Ye, Diarra, Traore, Hugues A, Nadembega, Christelle, Konate, Justin, Zongo, Arsene, Ouedraogo, Abass, Neboua, Desire, Belemvire, Aissatou, Bambara, Armel, Boncoungou, Justine, Zoungrana, Danielle, Nikodem, Cheryl, Harper, Kim, Jackson, Debra, Sanders, David, Sunday, Amwe, Okegbe-Eze, Collins, Williams, Xoliswa, Mshweshwe, Nolundi, Henge, Vatiswa, Gomba, Fikiswa, Nikodem, Lada, Khondowe, Oswell, Mwiya, Mwiya, Lusaka, Mildreed, Chizyuka, Mary, Phiri, Mary, Imakando, Billies, Musaku, Mwenechanya, Kapasa, Monica, Rutagwera, David, Clement, Ngondwe, Mwaba, Hilton Mwila, Matoba, Japhet, Mwaba, Hilton, Siumita, Chafye, Chola, Katai, Mwamutanda, Patricia, Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)

Subjects
RNA viruses, Pediatrics, Physiology, Maternal Health, [SDV]Life Sciences [q-bio], Breastfeeding, lcsh:Medicine, HIV Infections, Pathology and Laboratory Medicine, Biochemistry, Geographical locations, Body Mass Index, Families, Hemoglobins, South Africa, 0302 clinical medicine, Endocrinology, Immunodeficiency Viruses, Interquartile range, Reproductive Physiology, Medicine and Health Sciences, Uganda, 030212 general & internal medicine, lcsh:Science, Children, 2. Zero hunger, Multidisciplinary, Lopinavir, 3. Good health, Breast Feeding, Medical Microbiology, Viral Pathogens, Cohort, Viruses, Female, Pathogens, Infants, medicine.drug, Research Article, Adult, medicine.medical_specialty, Anti-HIV Agents, 030231 tropical medicine, Zambia, Breast milk, Microbiology, 03 medical and health sciences, Young Adult, Acquired immunodeficiency syndrome (AIDS), Retroviruses, Burkina Faso, medicine, Lactation, Humans, Hemoglobin, Microbial Pathogens, Endocrine Physiology, business.industry, Lentivirus, lcsh:R, Organisms, Biology and Life Sciences, HIV, Proteins, medicine.disease, CD4 Lymphocyte Count, Age Groups, People and Places, Africa, Women's Health, Population Groupings, lcsh:Q, Neonatology, business, Breast feeding, Body mass index
Abstract

International audience; Breastfeeding is recommended for infants born to HIV-infected women in low-income settings. Both breastfeeding and HIV-infection are energy demanding. Our objective was to explore how exclusive and predominant breastfeeding changes body mass index (BMI) among breastfeeding HIV1-positive women participating in the ANRS12174 trial (clinical trial no NCT0064026). METHODS: HIV-positive women (n = 1 267) with CD4 count \textgreater350, intending to breastfeed HIV-negative infants were enrolled from Burkina Faso, South Africa, Uganda and Zambia and counselled on breastfeeding. N = 1 216 were included in the analysis. The trial compared Lamivudine and Lopinavir/Ritonavir as a peri-exposure prophylaxis. We ran a linear mixed-effect model with BMI as the dependent variable and exclusive or predominant breastfeeding duration as the key explanatory variable. RESULTS: Any breastfeeding or exclusive/predominant) breastfeeding was initiated by 99.6% and 98.6% of the mothers respectively in the first week after birth. The median (interquartile range: IQR) duration of the group that did any breastfeeding or the group that did exclusive /predominant breastfeeding were 9.5 (7.5; 10.6) and 5.8 (5.6; 5.9)) months, respectively. The median (IQR) age, BMI, CD4 count, and HIV viral load at baseline (day 7) were 27 (23.3; 31) years, 23.7 (21.3; 27.0) kg/m2, 530 (432.5; 668.5) cells/μl and 0.1 (0.8; 13.7)1000 copies/mL, respectively. No major change in mean BMI was seen in this cohort over a 50-week period during lactation. The mean change between 26 and 50 weeks after birth was 0.7 kg/m2. Baseline mean BMI (measured on day 7 postpartum) and CD4 count were positively associated with maternal BMI change, with a mean increase of 1.0 kg/m2 (0.9; 1.0) per each additional baseline-BMI kilogram and 0.3 kg/m2 (0.2; 0.5) for each additional CD4 cell/μl, respectively. CONCLUSION: Breastfeeding was not negatively correlated with the BMI of HIV-1 infected Sub-Saharan African mothers. However, a higher baseline BMI and a CD4 count \textgreater500 cells/μl were associated with maternal BMI during the exclusive/ predominant breastfeeding period. Considering the benefits of breast milk for the infants and the recurrent results from different studies that breastfeeding is not harmful to the HIV-1-infected mothers, this study also supports the WHO 2016 guidelines on infant feeding that mothers living with HIV should breastfeed where formula is not safe for at least 12 months and up to 24 months, given that the right treatment or prophylaxis for the infection is administered. These findings and conclusions cannot be extrapolated to women who are immune-compromised or have AIDS.

Published
2017
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20. Efficacy and safety of subcutaneous administration of ceftazidime as a salvage therapy in geriatrics: a case report.

Author

Michelon, Hugues, Tardivel, Marie, Dinh, Aurélien, Alvarez, Jean‐Claude, Salomon, Elsa, Le Quintrec, Jean‐Laurent, Hirt, Deborah, and Davido, Benjamin

Subjects
CEFTAZIDIME, SALVAGE therapy, PSEUDOMONAS aeruginosa infections, DRUG monitoring, URINARY tract infections, GERIATRICS
Abstract

Ceftazidime is a third‐generation cephalosporin used for the treatment of Gram‐negative bacteria only approved for parenteral use by intravenous and intramuscular route. In some clinical situations, off‐label subcutaneous injection could be a salvage route for the administration of antibiotics, especially in geriatrics, despite the paucity of evidence about efficacy and safety. We report a case of a successful and well‐tolerated subcutaneous ceftazidime therapy in a 90‐year‐old woman for the treatment of an acute urinary tract infection caused by Pseudomonas aeruginosa with therapeutic drug monitoring data. [ABSTRACT FROM AUTHOR]

Published
2020
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22. A Physiologically-Based Pharmacokinetic Model to Predict Human Fetal Exposure for a Drug Metabolized by Several CYP450 Pathways

Author

De Sousa Mendes, Maïlys, primary, Lui, Gabrielle, additional, Zheng, Yi, additional, Pressiat, Claire, additional, Hirt, Deborah, additional, Valade, Elodie, additional, Bouazza, Naïm, additional, Foissac, Frantz, additional, Blanche, Stephane, additional, Treluyer, Jean-Marc, additional, Urien, Saik, additional, and Benaboud, Sihem, additional

Published
2016
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23. Extended pre-exposure prophylaxis with lopinavir–ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial

Author

Nagot, Nicolas, primary, Kankasa, Chipepo, additional, Tumwine, James K, additional, Meda, Nicolas, additional, Hofmeyr, G Justus, additional, Vallo, Roselyne, additional, Mwiya, Mwiya, additional, Kwagala, Mary, additional, Traore, Hugues, additional, Sunday, Amwe, additional, Singata, Mandisa, additional, Siuluta, Chafye, additional, Some, Eric, additional, Rutagwera, David, additional, Neboua, Desire, additional, Ndeezi, Grace, additional, Jackson, Debra, additional, Maréchal, Valérie, additional, Neveu, Dorine, additional, Engebretsen, Ingunn M S, additional, Lombard, Carl, additional, Blanche, Stéphane, additional, Sommerfelt, Halvor, additional, Rekacewicz, Claire, additional, Tylleskär, Thorkild, additional, Van de Perre, Philippe, additional, Nagot, Nicolas, additional, Marechal, Valerie, additional, Peries, Marianne, additional, Foulongne, Vincent, additional, Segondy, Michel, additional, Blanche, Stephane, additional, Treluyer, Jean-Marc, additional, Hirt, Deborah, additional, Karamagi, Charles, additional, Musoke, Philippa, additional, Mugaba, Proscovia M, additional, Murungi, Joan, additional, Muweesi, Hawa Nabuuma, additional, Ninsiima, Evelyn, additional, Baryeija, Simon, additional, Juma, Frederic, additional, Kata, Caleb Bwengye, additional, Katushabe, Stuart, additional, Ouédraogo, Rasmata, additional, Yé, Diarra, additional, Somé, Eric, additional, Traoré, Hugues A, additional, Nadembega, Christelle, additional, Konaté, Justin, additional, Zongo, Arsène, additional, Ouédraogo, Abass, additional, Néboua, Désiré, additional, Bélemviré, Aissatou, additional, Bambara, Armel, additional, Boncoungou, Justine, additional, Zoungrana, Danielle, additional, Nikodem, Cheryl, additional, Hofmeyr, Justus, additional, Harper, Kim, additional, Sanders, David, additional, Aku, Amwe, additional, Okegbe-Eze, Collins, additional, Williams, Xoliswa, additional, Mshweshwe, Nolundi, additional, Henge, Vatiswa, additional, Gomba, Fikiswa, additional, Gundu, Tapiwa, additional, Khondowe, Oswell, additional, Lusaka, Mildred, additional, Chizyuka, Mary, additional, Phiri, Mary, additional, Imakando, Billies, additional, Musaku, Mwenechanya, additional, Kapasa, Monica, additional, Clement, Gondwe, additional, Mwaba, Hilton Mwila, additional, Matoba, Japhet, additional, Chola, Katai, additional, Mwamutanda, Patricia, additional, Engebretsen, Ingunn, additional, Klungsøyr, Jørn, additional, van den Broeck, Jan, additional, and Blume, Jörn, additional

Published
2016
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24. Prediction of human fetal pharmacokinetics usingex vivohuman placenta perfusion studies and physiologically based models

Author

De Sousa Mendes, Maïlys, primary, Hirt, Deborah, additional, Vinot, Cécile, additional, Valade, Elodie, additional, Lui, Gabrielle, additional, Pressiat, Claire, additional, Bouazza, Naïm, additional, Foissac, Frantz, additional, Blanche, Stephane, additional, Lê, Minh Patrick, additional, Peytavin, Gilles, additional, Treluyer, Jean-Marc, additional, Urien, Saik, additional, and Benaboud, Sihem, additional

Published
2016
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25. Lopinavir/Ritonavir Monotherapy as a Nucleoside Analogue–Sparing Strategy to Prevent HIV-1 Mother-to-Child Transmission: The ANRS 135 PRIMEVA Phase 2/3 Randomized Trial

Author

Tubiana, Roland, primary, Mandelbrot, Laurent, additional, Le Chenadec, Jérome, additional, Delmas, Sandrine, additional, Rouzioux, Christine, additional, Hirt, Deborah, additional, Treluyer, Jean-Marc, additional, Ekoukou, Dieudonné, additional, Bui, Eda, additional, Chaix, Marie-Laure, additional, Blanche, Stéphane, additional, Warszawski, Josiane, additional, Ngondi, J, additional, Chernai, N, additional, Teglas, JP, additional, Laurent, C, additional, Huyn, P, additional, Le Chenadec, J, additional, Delmas, S, additional, Warszawski, J, additional, Muret, P, additional, Baazia, Y, additional, Jeantils, V, additional, Lachassine, E, additional, Rodrigues, A, additional, Sackho, A, additional, Sagnet-Pham, I, additional, Tassi, S, additional, Breilh, D, additional, Iriard, X, additional, Andre, G, additional, Douard, D, additional, Reigadas, S, additional, Roux, D, additional, Louis, I, additional, Morlat, P, additional, Pedebosq, S, additional, Barre, J, additional, Estrangin, E, additional, Fauveau, E, additional, Garrait, V, additional, Ledudal, P, additional, Pichon, C, additional, Richier, L, additional, Thebault, A, additional, Touboul, C, additional, Bornarel, D, additional, Chambrin, V, additional, Clech, L, additional, Dubreuil, P, additional, Foix L'helias, L, additional, Picone, O, additional, Schoen, H, additional, Stralka, M, additional, Crenn-Hebert, C, additional, Floch-Tudal, C, additional, Hery, E, additional, Ichou, H, additional, Mandelbrot, L, additional, Meier, F, additional, Tournier, V, additional, Walter, S, additional, Chevojon, P, additional, Devidas, A, additional, Granier, M, additional, Khanfar-boudjemai, M, additional, Malbrunot, C, additional, Nguyen, R, additional, Ollivier, B, additional, Radideau, E, additional, Turpault, I, additional, Jault, T, additional, Barrail, A, additional, Colmant, C, additional, Fourcade, C, additional, Goujard, C, additional, Pallier, C, additional, Peretti, D, additional, Taburet, AM, additional, Bocket, L, additional, D'angelo, S, additional, Godart, F, additional, Hammou, Y, additional, Houdret, N, additional, Mazingue, F, additional, Thielemans, B, additional, Brochier, C, additional, Cotte, L, additional, Januel, F, additional, Le Thi, T, additional, Gagneux, MC, additional, Bozio, A, additional, Massardier, J, additional, Kebaïli, K, additional, Ben, Akli K, additional, Heller-Roussin, B, additional, Riehl, C, additional, Roos, S, additional, Taccot, F, additional, Winter, C, additional, Arias, J, additional, Brunet-François, C, additional, Dailly, E, additional, Flet, L, additional, Gournay, V, additional, Mechinaud, F, additional, Reliquet, V, additional, Winner, N, additional, Peytavin, G, additional, Bardin, C, additional, Boudjoudi, N, additional, Compagnucci, A, additional, Guerin, C, additional, Krivine, A, additional, Pannier, E, additional, Salmon, D, additional, Treluyer, JM, additional, Firtion, G, additional, Ayral, D, additional, Ciraru-Vigneron, N, additional, Mazeron, MC, additional, Rizzo Badoin, N, additional, Trout, H, additional, Benachi, A, additional, Boissand, C, additional, Bonnet, D, additional, Boucly, S, additional, Blanche, S, additional, Chaix, ML, additional, Duvivier, C, additional, Parat, S, additional, Cayol, V, additional, Oucherif, S, additional, Rouzioux, C, additional, Viard, JP, additional, Bonmarchand, M, additional, De Montgolfier, I, additional, Dommergues, M, additional, Fievet, MH, additional, Iguertsira, M, additional, Pauchard, M, additional, Quetin, F, additional, Soulie, C, additional, Tubiana, R, additional, Faye, A, additional, Magnier, S, additional, Bui, E, additional, Carbonne, B, additional, Daguenel Nguyen, A, additional, Harchi, N, additional, Meyohas, MC, additional, Poirier, JM, additional, Rodriguez, J, additional, Hervé, F, additional, Pialloux, G, additional, Dehee, A, additional, Dollfus, C, additional, Tillous Borde, I, additional, Vaudre, G, additional, Wallet, A, additional, Allemon, MC, additional, Bolot, P, additional, Boussairi, A, additional, Chaplain, C, additional, Ekoukou, D, additional, Ghibaudo, N, additional, Kana, JM, additional, Khuong, MA, additional, Weil, M, additional, Entz-Werle, N, additional, Livolsi Lutz, P, additional, Beretz, L, additional, Cheneau, M, additional, Partisani, ML, additional, Schmitt, MP, additional, Acar, P, additional, Armand, E, additional, Berrebi, A, additional, Guibaud Plo, C, additional, Lavit, M, additional, Nicot, F, additional, Tricoire, J, additional, Ajana, F, additional, and Huleux, T, additional

Published
2013
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29. Influence of Body Weight on Achieving Indinavir Concentrations Within Its Therapeutic Window in HIV-Infected Thai Patients Receiving Indinavir Boosted With Ritonavir

Author

Cressey, Tim R, primary, Urien, Saik, additional, Hirt, Deborah, additional, Halue, Guttiga, additional, Techapornroong, Malee, additional, Bowonwatanuwong, Chureeratana, additional, Leenasirimakul, Prattana, additional, Treluyer, Jean-Marc, additional, Jourdain, Gonzague, additional, and Lallemant, Marc, additional

Published
2011
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30. Lopinavir-Ritonavir Impairs Adrenal Function in Infants

Author

Kariyawasam, Dulanjalee, Peries, Marianne, Foissac, Frantz, Eymard-Duvernay, Sabrina, Tylleskär, Thorkild, Singata-Madliki, Mandisa, Kankasa, Chipepo, Meda, Nicolas, Tumwine, James, Mwiya, Mwiya, Engebretsen, Ingunn, Flück, Christa E., Hartmann, Michaela F, Wudy, Stefan A, Hirt, Deborah, Treluyer, Jean Marc, Molès, Jean-Pierre, Blanche, Stéphane, Van De Perre, Philippe, Polak, Michel, and Nagot, Nicolas

Subjects
570 Life sciences, biology, 610 Medicine & health, 3. Good health
Abstract

BACKGROUND Perinatal treatment with lopinavir boosted by ritonavir (LPV/r) is associated with steroidogenic abnormalities. Long-term effects in infants have not been studied. METHODS Adrenal-hormone profiles were compared at weeks 6 and 26 between human immunodeficiency virus (HIV)-1-exposed but uninfected infants randomly assigned at 7 days of life to prophylaxis with LPV/r or lamivudine (3TC) to prevent transmission during breastfeeding. LPV/r in vitro effect on steroidogenesis was assessed in H295R cells. RESULTS At week 6, 159 frozen plasma samples from Burkina Faso and South Africa were assessed (LPV/r group: n = 92; 3TC group: n = 67) and at week 26, 95 samples from Burkina Faso (LPV/r group: n = 47; 3TC group: n = 48). At week 6, LPV/r-treated infants had a higher median dehydroepiandrosterone (DHEA) level than infants from the 3TC arm: 3.91 versus 1.48 ng/mL (P < .001). Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children. There was a significant correlation between the DHEA and LPV/r AUC levels (ρ = 0.40, P = .019) and Ctrough (ρ = 0.40, P = .017). At week 26, DHEA levels remained higher in the LPV/r arm: 0.45 versus 0.13 ng/mL (P = .002). Lopinavir, but not ritonavir, inhibited CYP17A1 and CYP21A2 activity in H295R cells. CONCLUSIONS Lopinavir was associated with dose-dependent adrenal dysfunction in infants. The impact of long-term exposure and potential clinical consequences require evaluation.Giving lopinavir to infants during their first year of life induces early, asymptomatic adrenal disruption compatible with the combined inhibition of CYP 21 and CYP 17 enzymes. The impact of prolonged treatment on the adrenal glands may require further attention.

31. Lopinavir-Ritonavir Impairs Adrenal Function in Infants.

Author

Kariyawasam D, Peries M, Foissac F, Eymard-Duvernay S, Tylleskär T, Singata-Madliki M, Kankasa C, Meda N, Tumwine J, Mwiya M, Engebretsen I, Flück CE, Hartmann MF, Wudy SA, Hirt D, Treluyer JM, Molès JP, Blanche S, Van De Perre P, Polak M, and Nagot N

Subjects
Burkina Faso, Child, Female, Humans, Infant, Lopinavir therapeutic use, Pregnancy, Ritonavir adverse effects, South Africa, Steroid 21-Hydroxylase, Anti-HIV Agents adverse effects, HIV Infections drug therapy
Abstract

Background: Perinatal treatment with lopinavir boosted by ritonavir (LPV/r) is associated with steroidogenic abnormalities. Long-term effects in infants have not been studied., Methods: Adrenal-hormone profiles were compared at weeks 6 and 26 between human immunodeficiency virus (HIV)-1-exposed but uninfected infants randomly assigned at 7 days of life to prophylaxis with LPV/r or lamivudine (3TC) to prevent transmission during breastfeeding. LPV/r in vitro effect on steroidogenesis was assessed in H295R cells., Results: At week 6, 159 frozen plasma samples from Burkina Faso and South Africa were assessed (LPV/r group: n = 92; 3TC group: n = 67) and at week 26, 95 samples from Burkina Faso (LPV/r group: n = 47; 3TC group: n = 48). At week 6, LPV/r-treated infants had a higher median dehydroepiandrosterone (DHEA) level than infants from the 3TC arm: 3.91 versus 1.48 ng/mL (P < .001). Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children. There was a significant correlation between the DHEA and LPV/r AUC levels (ρ = 0.40, P = .019) and Ctrough (ρ = 0.40, P = .017). At week 26, DHEA levels remained higher in the LPV/r arm: 0.45 versus 0.13 ng/mL (P = .002). Lopinavir, but not ritonavir, inhibited CYP17A1 and CYP21A2 activity in H295R cells., Conclusions: Lopinavir was associated with dose-dependent adrenal dysfunction in infants. The impact of long-term exposure and potential clinical consequences require evaluation., Clinical Trials Registration: NCT00640263., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Published
2020
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