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1. Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials

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Hermine, Olivier, Mariette, Xavier, Ravaud, Philippe, Bureau, Serge, Dougados, Maxime, Resche-Rigon, Matthieu, Tharaux, Pierre-Louis, Tibi, Annick, Azoulay, Elie, Cadranel, Jacques, Emmerich, Joseph, Fartoukh, Muriel, Guidet, Bertrand, Humbert, Marc, Lacombe, Karine, Mahevas, Matthieu, Pene, Frédéric, Porcher, Raphaël, Pourchet-Martinez, Valerie, Schlemmer, Frédéric, Yazdanpanah, Yazdan, Baron, Gabriel, Perrodeau, Elodie, Vanhoye, Damien, Kedzia, Cécile, Demerville, Lauren, Gysembergh-Houal, Anne, Bourgoin, Alexandre, Raked, Nabil, Mameri, Lakhdar, Montlahuc, Claire, Biard, Lucie, Alary, St.phanie, Hamiria, Samir, Bariz, Thinhinane, Semri, Hala, Hai, Dhiaa Meriem, Benafla, Moustafa, Belloul, Mohamed, Vauboin, Pernelle, Flamand, Saskia, Pacheco, Claire, Walter-Petrich, Anouk, Stan, Emilia, Benarab, Souad, Nyanou, Corine, Charreteur, Robin, Dupre, Céline, Cardet, Kévin, Lehmann, Blandine, Baghli, Kamyl, Madelaine, Claire, D'Ortenzio, Eric, Puéchal, Oriane, Semaille, Caroline, Savale, Laurent, Harrois, Anatole, Figueiredo, Samy, Duranteau, Jacques, Anguel, Nadia, Pavot, Arthur, Monnet, Xavier, Richard, Christian, Teboul, Jean-Louis, Durand, Philippe, Tissieres, Pierre, Jevnikar, Mitja, Montani, David, Pavy, Stephan, Nocturne, Gaétane, Bitoun, Samuel, Noel, Nicolas, Lambotte, Olivier, Escaut, Lelia, Jauréguiberry, Stephane, Baudry, Elodie, Verny, Christiane, Lefevre, Edouard, Zaidan, Mohamad, Molinari, Domitille, Leprun, Gaël, Fourreau, Alain, Cylly, Laurent, Grimaldi, Lamiae, Virlouvet, Myriam, Meftali, Ramdane, Fabre, Soléne, Licois, Marion, Mamoune, Asmaa, Boudali, Yacine, Le Tiec, Clotilde, Verstuyft, Céline, Roques, Anne-Marie, Georgin-Lavialle, Sophie, Senet, Patricia, Pialoux, Gilles, Soria, Angele, Parrot, Antoine, François, Helene, Rozensztajn, Nathalie, Blin, Emmanuelle, Choinier, Pascaline, Camuset, Juliette, Rech, Jean-Simon, Canellas, Antony, Rolland-Debord, Camille, Lemarié, Nadege, Belaube, Nicolas, Nadal, Marine, Siguier, Martin, Petit-Hoang, Camille, Chas, Julie, Drouet, Elodie, Lemoine, Matthieu, Phibel, Audrey, Aunay, Lucie, Bertrand, Eliane, Ravato, Sylviane, Vayssettes, Marie, Adda, Anne, Wilpotte, Celine, Thibaut, Pélagie, Fillon, Julie, Debrix, Isabelle, Fellahi, Soraya, Bastard, Jean-Philippe, Lefévre, Guillaume, Gottenberg, Jacques-Eric, Hansmann, Yves, Blanc, Frédéric, Ohlmann-Caillard, Sophie, Castelain, Vincent, Chatelus, Emmanuel, Chatron, Eva, Collange, Olivier, Danion, François, De Blay, Frédéric, Diemunsch, Pierre, Diemunsch, Sophie, Felten, Renaud, Goichot, Bernard, Greigert, Valentin, Guffroy, Aurelien, Heger, Bob, Kaeuffer, Charlotte, Kassegne, Loic, Korganow, Anne Sophie, Le Borgne, Pierrick, Lefebvre, Nicolas, Mertes, Paul-Michel, Noll, Eric, Oberlin, Mathieu, Poindron, Vincent, Pottecher, Julien, Ruch, Yvon, Weill, François, Meyer, Nicolas, Andres, Emmanuel, Demonsant, Eric, Tayebi, Hakim, Nisand, Gabriel, Brin, Stéphane, Sublon, Cédric, Becker, Guillaume, Hutt, Anne, Martin, Tristan, Bayer, Sophie, Metzger, Catherine, Mekinian, Arsene, Abisror, Noémie, Adedjouma, Amir, Bollens, Diane, Bonneton, Marion, Bourcicaux, Nathalie, Bourrier, Anne, Thibault Chiarabiani, Maria Chauchard, Chopin, Doroth.e, Cohen, Jonathan, Devred, Ines, Donadille, Bruno, Fain, Olivier, Hariri, Geoffrey, Jachiet, Vincent, Ingliz, Patrick, Garnier, Marc, Gatfosse, Marc, Ghrenassia, Etienne, Gobert, Delphine, Krause le Garrec, Jessica, Landman, Cecilia, Lavillegrand, Jean Remy, Lefebvre, Benedicte, Mahevas, Thibault, Mazerand, Sandie, Meynard, Jean Luc, Morgand, Marjolaine, Ouaz.ne, Zineb, Pacanowski, Jerome, Riviere, S.bastien, Seksik, Philippe, Sokol, Harry, Soliman, Heithem, Valin, Nadia, Urbina, Thomas, McAvoy, Chloé, Miranda, Maria Pereira, Aratus, Gladys, Berard, Laurence, Simon, Tabassome, Nguyen, Anne Daguenel, Girault, Elise, Mayala-Kanda, Cl.mentine, Antignac, Marie, Leplay, Céline, Arlet, Jean-Benoit, Diehl, Jean-Luc, Bellenfant, Florence, Blanchard, Anne, Buffet, Alexandre, Cholley, Bernard, Fayol, Antoine, Flamarion, Edouard, Godier, Anne, Gorget, Thomas, Hamada, Sophie-Rym, Hauw-Berlemont, Caroline, Hulot, Jean-Sébastien, Lebeaux, David, Livrozet, Marine, Michon, Adrien, Neuschwander, Arthur, Pennet, Marie-Aude, Planquette, Benjamin, Ranque, Brigitte, Sanchez, Olivier, Volle, Geoffroy, Briois, Sandrine, Cornic, Mathias, Elisee, Virginie, Denis, Jesuthasan, Djadi-Prat, Juliette, Jouany, Pauline, Junquera, Ramon, Henriques, Mickael, Kebir, Amina, Lehir, Isabelle, Meunier, Jeanne, Patin, Florence, Paquet, Val.rie, Tréhan, Anne, Vigna, Véronique, Sabatier, Brigitte, Bergerot, Damien, Jouve, Charléne, Knosp, Camille, Lenoir, Olivia, Mahtal, Nassim, Resmini, Léa, Lescure, Xavier, Ghosn, Jade, Bachelard, Antoine, Rachline, Anne, Isernia, Valentina, Bao-chau, Phung, Vallois, Dorothée, Sautereau, Aurelie, Neukrich, Catherine, Dossier, Antoine, Borie, Raphaël, Crestani, Bruno, Ducrocq, Gregory, Steg, Philippe Gabriel, Dieude, Philippe, Papo, Thomas, Marcault, Estelle, Chaudhry, Marhaba, Da Silveira, Charléne, Metois, Annabelle, Mahenni, Ismahan, Meziani, Meriam, Nilusmas, Cyndie, Le Gac, Sylvie, Ndiaye, Awa, Louni, Fran.oise, Chansombat, Malikhone, Julia, Zelie, Chalal, Solaya, Chalal, Lynda, Kramer, Laura, Le Grand, Jeniffer, Ouifiya, Kafif, Piquard, Valentine, Tubiana, Sarah, Nguyen, Yann, Honsel, Vasco, Weiss, Emmanuel, Codorniu, Anais, Zarrouk, Virginie, de Lastours, Victoire, Uzzan, Matthieu, Gamany, Naura, Claveirole, Agathe, Navid, Alexandre, Fouque, Tiffanie, Cohen, Yonathan, Lupo, Maya, Gilles, Constance, Rahli, Roza, Louis, Zeina, Boutboul, David, Galicier, Lionel, Amara, Yaël, Archer, Gabrielle, Benattia, Amira, Bergeron, Anne, Bondeelle, Louise, de Castro, Nathalie, Clément, Melissa, Darmon, Michaël, Denis, Blandine, Dupin, Clairelyne, Feredj, Elsa, Feyeux, Delphine, Joseph, Adrien, Lenglin, Etienne, Le Guen, Pierre, Liégeon, Geoffroy, Lorillon, Gwenaël, Mabrouki, Asma, Mariotte, Eric, Martin de Frémont, Grégoire, Mirouse, Adrien, Molina, Jean-Michel, Peffault de Latour, Régis, Oksenhendler, Eric, Saussereau, Julien, Tazi, Abdellatif, Tudesq, Jean-Jacques, Zafrani, Lara, Brindele, Isabelle, Bugnet, Emmanuelle, Lebras, Karine Celli, Chabert, Julien, Djaghout, Lamia, Fauvaux, Catherine, Jegu, Anne Lise, Kozakiewicz, Ewa, Meunier, Martine, Tremorin, Marie-Thérèse, Davoine, Claire, Madelaine, Isabelle, Caillat-Zucman, Sophie, Delaugerre, Constance, Morin, Florence, Sène, Damien, Burlacu, Ruxandra, Chousterman, Benjamin, Mégarbanne, Bruno, Richette, Pascal, Riveline, Jean-Pierre, Frazier, Aline, Vicaut, Eric, Berton, Laure, Hadjam, Tassadit, Vazquez-Ibarra, Miguel Alejandro, Jourdaine, Clément, Tran, Olivia, Jouis, Véronique, Jacob, Aude, Smati, Julie, Renaud, Stéphane, Pernin, Claire, Suarez, Lydia, Semerano, Luca, Abad, Sébastien, nainous, Ruben B., Bonnet, Nicolas, Comparon, Celine, Cohen, Yves, Cordel, Hugues, Dhote, Robin, Dournon, Nathalie, Duchemann, Boris, Ebstein, Nathan, Gille, Thomas, Giroux-Leprieur, Benedicte, Goupil de Bouille, Jeanne, Nunes, Hilario, Oziel, Johanna, Roulot, Dominique, Sese, Lucile, ClaireTantet, Uzunhan, Yurdagul, Bloch-Queyrat, Coralie, Levy, Vincent, Messani, Fadhila, Rahaoui, Mohammed, Petit, Myléne, Brahmi, Sabrina, Rathoin, Vanessa, Rigal, Marthe, Costedoat-Chalumeau, Nathalie, Luong, Liem Binh, Hamou, Zakaria Ait, Benghanem, Sarah, Blanche, Philippe, Carlier, Nicolas, Chaigne, Benjamin, Gauzit, Remy, Joumaa, Hassan, Jozwiak, Mathieu, Lachétre, Marie, Lafoeste, Hélène, Launay, Odie, Legendre, Paul, Marey, Jonathan, Morbieu, Caroline, Palmieri, Lola-Jade, Szwebel, Tali-Anne, Abdoul, Hendy, Bruneau, Alexandra, Beclin-Clabaux, Audrey, Larrieu, Charly, Montanari, Pierre, Dufour, Eric, Clarke, Ada, Le Bourlout, Catherine, Marin, Nathalie, Menage, Nathalie, Saleh-Mghir, Samira, Cisse, Mamadou Salif, Cheref, Kahina, Guerin, Corinne, Zerbit, Jérémie, Michel, Marc, Gallien, Sébastien, Crickx, Etienne, Le Vavasseur, Benjamin, Kempf, Emmanuelle, Jaffal, Karim, Vindrios, William, Oniszczuk, Julie, Guillaud, Constance, Lim, Pascal, Fois, Elena, Melica, Giovanna, Matignon, Marie, Jalabert, Maud, Lelièvre, Jean-Daniel, Schmitz, David, Bourhis, Marion, Belazouz, Sylia, Languille, Laetitia, Boucle, Caroline, Cita, Nelly, Didier, Agnés, Froura, Fahem, Ledudal, Katia, Sadaoui, Thiziri, Thiemele, Alaki, Le Febvre De Bailly, Delphine, Verlinde, Muriel Carvhalo, Mayaux, Julien, Cacoub, Patrice, Saadoun, David, Vautier, Mathieu, Bugaut, Héléne, Benveniste, Olivier, Allenbach, Yves, Leroux, Gaëlle, Rigolet, Aude, Guillaume-Jugnot, Perrine, Domont, Fanny, Desbois, Anne Claire, Comarmond, Chloé, Champtiaux, Nicolas, Toquet, Segolene, Ghembaza, Amine, Vieira, Matheus, Maalouf, Georgina, Boleto, Goncalo, Ferfar, Yasmina, Corvol, Jean-Christophe, Louapre, C.line, Sambin, Sara, Mariani, Louise-Laure, Karachi, Carine, Tubach, Florence, Estellat, Candice, Gimeno, Linda, Martin, Karine, Bah, Aicha, Keo, Vixra, Ouamri, Sabrine, Messaoudi, Yasmine, Yelles, Nessima, Faye, Pierre, Cavelot, Sebastien, Larcheveque, Cecile, Annonay, Laurence, Benhida, Jaouad, Zahrate-Ghoul, Aida, Hammal, Soumeya, Belilita, Ridha, Charbonnier, Fanny, Aguilar, Claire, Alby-Laurent, Fanny, Burger, Carole, Campos-Vega, Clara, Chavarot, Nathalie, Fournier, Benjamin, Rouzaud, Claire, Vimpére, Damien, Elie, Caroline, Bakouboula, Prissile, Choupeaux, Laure, Granville, Sophie, Issorat, Elodie, Broissand, Christine, Alyanakian, Marie-Alexandra, Geri, Guillaume, Derridj, Nawal, Sguiouar, Naima, Meddah, Hakim, Djadel, Mourad, Chambrin-Lauvray, Héléne, Duclos-vallée, Jean-Charles, Saliba, Faouzi, Sacleux, Sophie-Caroline, Kounis, Ilias, Tamazirt, Sonia, Rudant, Eric, Michot, Jean-Marie, Stoclin, Annabelle, Colomba, Emeline, Pommeret, Fanny, Willekens, Christophe, Da Silva, Rosa, Dejean, Valérie, Mekid, Yasmina, Ben-Mabrouk, Ines, Netzer, Florence, Pradon, Caroline, Drouard, Laurence, Camara-Clayette, Valérie, Morel, Alexandre, Garcia, Gilles, Mohebbi, Abolfazl, Berbour, Férial, Dehais, Mélanie, Pouliquen, Anne-Lise, Klasen, Alison, Soyez-Herkert, Loren, London, Jonathan, Keroumi, Younes, Guillot, Emmanuelle, Grailles, Guillaume, El amine, Younes, Defrancq, Fanny, Fodil, Hanane, Bouras, Chaouki, Dautel, Dominique, Gambier, Nicolas, Dieye, Thierno, Bienvenu, Boris, Lancon, Victor, Lecomte, Laurence, Beziriganyan, Kristina, Asselate, Belkacem, Allanic, Laure, Kiouris, Elena, Legros, Marie-Héléne, Lemagner, Christine, Martel, Pascal, Provitolo, Vincent, Ackermann, Félix, Le Marchand, Mathilde, Chan Hew Wai, Aurélie, Fremont, Dimitri, Coupez, Elisabeth, Adda, Mireille, Duée, Frédéric, Bernard, Lise, Gros, Antoine, Henry, Estelle, Courtin, Claire, Pattyn, Anne, Guinot, Pierre-Grégoire, Bardou, Marc, Maurer, Agnes, Jambon, Julie, Cransac, Amélie, Pernot, Corinne, Mourvillier, Bruno, Marquis, Eric, Benoit, Philippe, Roux, Damien, Gernez, Coralie, Yelnik, Cécile, Poissy, Julien, Nizard, Mandy, Denies, Fanette, Gros, Helene, Mourad, Jean-Jacques, Sacco, Emmanuelle, Renet, Sophie, Ader, F., Yazdanpanah, Y., Mentre, F., Peiffer-Smadja, N., Lescure, F.X., Poissy, J., Bouadma, L., Timsit, J.F., Lina, B., Morfin-Sherpa, F., Bouscambert, M., Gaymard, A., Peytavin, G., Abel, L., Guedj, J., Andrejak, C., Burdet, C., Laouenan, C., Belhadi, D., Dupont, A., Alfaiate, T., Basli, B., Chair, A., Laribi, S., Level, J., Schneider, M., Tellier, M.C., Dechanet, A., Costagliola, D., Terrier, B., Ohana, M., Couffin-Cadiergues, S., Esperou, H., Delmas, C., Saillard, J., Fougerou, C., Moinot, L., Wittkop, L., Cagnot, C., Le Mestre, S., Lebrasseur-Longuet, D., Petrov-Sanchez, V., Diallo, A., Mercier, N., Icard, V., Leveau, B., Tubiana, S., Hamze, B., Gelley, A., Noret, M., D’Ortenzio, E., Puechal, O., Semaille, C., Welte, T., Paiva, J.A., Halanova, M., Kieny, M.P., Balssa, E., Birkle, C., Gibowski, S., Landry, E., Le Goff, A., Moachon, L., Moins, C., Wadouachi, L., Paul, C., Levier, A., Bougon, D., Djossou, F., Epelboin, L., Dellamonica, J., Marquette, C.H., Robert, C., Gibot, S., Senneville, E., Jean-Michel, V., Zerbib, Y., Chirouze, C., Boyer, A., Cazanave, C., Gruson, D., Malvy, D., Andreu, P., Quenot, J.P., Terzi, N., Faure, K., Chabartier, C., Le Moing, V., Klouche, K., Ferry, T., F, Valour, Gaborit, B., Canet, E., Le Turnier, P., Boutoille, D., Bani-Sadr, F., Benezit, F., Revest, M., Cameli, C., Caro, A., Um Tegue, MJ Ngo, Le Tulzo, Y., Laviolle, B., Laine, F., Thiery, G., Meziani, F., Hansmann, Y., Oulehri, W., Tacquard, C., Vardon-Bounes, F., Riu-Poulenc, B., Murris-Espin, M., Bernard, L., Garot, D., Hinschberger, O., Martinot, M., Bruel, C., Pilmis, B., Bouchaud, O., Loubet, P., Roger, C., Monnet, X., Figueiredo, S., Godard, V., Mira, J.P., Lachatre, M., Kerneis, S., Aboab, J., Sayre, N., Crockett, F., Lebeaux, D., Buffet, A., Diehl, J.L., Fayol, A., Hulot, J.S., Livrozet, M., Dessap, A Mekontso, Ficko, C., Stefan, F., Le Pavec, J., Mayaux, J., Ait-Oufella, H., Molina, J.M., Pialoux, G., Fartoukh, M., Textoris, J., Brossard, M., Essat, A., Netzer, E., Riault, Y., Ghislain, M., Beniguel, L., Genin, M., Gouichiche, L., Betard, C., Belkhir, L., Altdorfer, A., Centro, V Fraipont, Braz, S., Ribeiro, JM Ferreira, Alburqueque, R Roncon, Berna, M., Alexandre, M., Lamprecht, B., Egle, A., Greil, R., Joannidis, M., Patterson, Thomas F., Ponce, Philip O., Taylor, Barbara S., Patterson, Jan E., Bowling, Jason E., Javeri, Heta, Kalil, Andre C., Larson, LuAnn, Hewlett, Angela, Mehta, Aneesh K., Rouphael, Nadine G., Saklawi, Youssef, Scanlon, Nicholas, Traenkner, Jessica J., Trible, Ronald P., Jr., Walter, Emmanuel B., Ivey, Noel, Holland, Thomas L., Ruiz-Palacios, Guillermo M., Ponce de León, Alfredo, Rajme, Sandra, Hsieh, Lanny, Amin, Alpesh N., Watanabe, Miki, Lee, Helen S., Kline, Susan, Billings, Joanne, Noren, Brooke, Kim, Hyun, Bold, Tyler D., Tapson, Victor, Grein, Jonathan, Sutterwala, Fayyaz, Iovine, Nicole, Beattie, Lars K., Wakeman, Rebecca Murray, Shaw, Matthew, Jain, Mamta K., Mocherla, Satish, Meisner, Jessica, Luque, Amneris, Sweeney, Daniel A., Benson, Constance A., Ali, Farhana, Atmar, Robert L., El Sahly, Hana M., Whitaker, Jennifer, Falsey, Ann R., Branche, Angela R., Rozario, Cheryl, Pineda, Justino Regalado, Martinez-Orozco, José Arturo, Lye, David Chien, Ong, Sean WX., Chia, Po Ying, Young, Barnaby E., Sandkovsky, Uriel, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Cantos, Valeria D., Kelley, Colleen F., Rebolledo Esteinou, Paulina A., Kandiah, Sheetal, Doernberg, Sarah B., Crouch, Pierre-Cedric B., Jang, Hannah, Luetkemeyer, Anne F., Dwyer, Jay, Cohen, Stuart H., Thompson, George R., 3rd, Nguyen, Hien H., Finberg, Robert W., Wang, Jennifer P., Perez-Velazquez, Juan, Wessolossky, Mireya, Jackson, Patrick E.H., Bell, Taison D., West, Miranda J., Taiwo, Babafemi, Krueger, Karen, Perez, Johnny, Pearson, Triniece, Paules, Catharine I., Julian, Kathleen G., Ahmad, Danish, Hajduczok, Alexander G., Arguinchona, Henry, Arguinchona, Christa, Erdmann, Nathaniel, Goepfert, Paul, Ahuja, Neera, Frank, Maria G., Wyles, David, Young, Heather, Oh, Myoung-don, Park, Wan Beom, Kang, Chang Kyung, Marconi, Vincent, Moanna, Abeer, Cribbs, Sushma, Harrison, Telisha, Kim, Eu Suk, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Tan, Seow Yen, Shafi, Humaira, Chien, Jaime, Fong, Raymond KC., Murray, Daniel D., Lundgren, Jens, Nielsen, Henrik, Jensen, Tomas, Zingman, Barry S., Grossberg, Robert, Riska, Paul F., Yang, Otto O., Ahn, Jenny, Arias, Rubi, Rapaka, Rekha R., Hauser, Naomi, Campbell, James D., Short, William R., Tebas, Pablo, Baron, Jillian T., McLellan, Susan L.F., Blanton, Lucas S., Seashore, Justin B., Creech, C. Buddy, Rice, Todd W., Walker, Shannon, Thomsen, Isaac P., Lopez de Castilla, Diego, Van Winkle, Jason W., Riedo, Francis X., Pada, Surinder Kaur, Wang, Alvin DY., Lin, Li, Harkins, Michelle, Mertz, Gregory, Sosa, Nestor, Ann Chai, Louis Yi, Tambyah, Paul Anantharajah, Tham, Sai Meng, Archuleta, Sophia, Yan, Gabriel, Lindholm, David A., Markelz, Ana Elizabeth, Mende, Katrin, Mularski, Richard, Hohmann, Elizabeth, Torres-Soto, Mariam, Jilg, Nikolaus, Maves, Ryan C., Utz, Gregory C., George, Sarah L., Hoft, Daniel F., Brien, James D., Paredes, Roger, Mateu, Lourdes, Loste, Cora, Kumar, Princy, Thornton, Sarah, Mohanraj, Sharmila, Hynes, Noreen A., Sauer, Lauren M., Colombo, Christopher J., Schofield, Christina, Colombo, Rhonda E., Chambers, Susan E., Novak, Richard M., Wendrow, Andrea, Gupta, Samir K., Lee, Tida, Lalani, Tahaniyat, Holodniy, Mark, Chary, Aarthi, Huprikar, Nikhil, Ganesan, Anuradha, Ohmagari, Norio, Mikami, Ayako, Price, D. Ashley, Duncan, Christopher J.A., Dierberg, Kerry, Neumann, Henry J., Taylor, Stephanie N., Lacour, Alisha, Masri, Najy, Swiatlo, Edwin, Widmer, Kyle, Neaton, James D., Bessesen, Mary, Stephens, David S., Burgess, Timothy H., Uyeki, Timothy M., Walker, Robert, Marks, G. Lynn, Osinusi, Anu, Cao, Huyen, Cardoso, Anabela, de Bono, Stephanie, Schlichting, Douglas E., Chung, Kevin K., Ferreira, Jennifer L., Green, Michelle, Makowski, Mat, Wierzbicki, Michael R., Conrad, Tom M., El-Khorazaty, Jill Ann, Hill, Heather, Bonnett, Tyler, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Beigel, John H., Tomashek, Kay M., Ghazaryan, Varduhi, Beresnev, Tatiana, Nayak, Seema, Dodd, Lori E., Dempsey, Walla, Nomicos, Effie, Lee, Marina, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Yokum, Tammy, Arega, Janice, Florese, Ruth, Voell, Jocelyn D., Davey, Richard, Serrano, Ruth C., Wiley, Zanthia, Phadke, Varun K., Goepfert, Paul A., Gomez, Carlos A., Sofarelli, Theresa A., Certain, Laura, Imlay, Hannah N., Wolfe, Cameron R., Ko, Emily R., Engemann, John J., Felix, Nora Bautista, Wan, Claire R., Elmor, Sammy T., Bristow, Laurel R., Harkins, Michelle S., Iovine, Nicole M., Elie-Turenne, Marie-Carmelle, Tapson, Victor F., Choe, Pyoeng Gyun, Mularski, Richard A., Rhie, Kevin S., Hussein, Rezhan H., Ince, Dilek, Winokur, Patricia L., Takasaki, Jin, Saito, Sho, McConnell, Kimberly, Wyles, David L., Sarcone, Ellen, Grimes, Kevin A., Perez, Katherine, Janak, Charles, Whitaker, Jennifer A., Rebolledo, Paulina A., Gharbin, John, Lambert, Allison A., Zea, Diego F., Bainbridge, Emma, Hostler, David C., Hostler, Jordanna M., Shahan, Brian T., Ling, Evelyn, Go, Minjoung, Hubbard, Fleesie A., Chakrabarty, Melony, Laguio-Vila, Maryrose, Walsh, Edward E., Guirgis, Faheem, Marconi, Vincent C., Madar, Christian, Borgetti, Scott A., Levine, Corri, Nock, Joy, Candiotti, Keith, Rozman, Julia, Dangond, Fernando, Hyvert, Yann, Seitzinger, Andrea, Cross, Kaitlyn, Pettibone, Stephanie, Nayak, Seema U., Deye, Gregory A., Siempos, Ilias I., Belhadi, Drifa, Veiga, Viviane Cordeiro, Cavalcanti, Alexandre Biasi, Branch-Elliman, Westyn, Papoutsi, Eleni, Gkirgkiris, Konstantinos, Xixi, Nikoleta A., and Kotanidou, Anastasia

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2024
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2. Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV – Week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial

Author

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

Published
2023
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3. Long‐term clinical, virological and immunological outcomes following planned treatment interruption in HIV‐infected children.

Author

Freguja, R, Bamford, A, Zanchetta, M, Del Bianco, P, Giaquinto, C, Harper, L, Dalzini, A, Cressey, TR, Compagnucci, A, Saidi, Y, Riault, Y, Ford, D, Gibb, D, Klein, N, and De Rossi, A

Subjects
HIV infections, HIV-positive persons, CONFIDENCE intervals, RESEARCH methodology, HEALTH outcome assessment, REGRESSION analysis, RNA, TREATMENT effectiveness, HIGHLY active antiretroviral therapy, STRUCTURED treatment interruption, IMMUNOPHENOTYPING, CD4 lymphocyte count, DESCRIPTIVE statistics, VIROLOGY, LONGITUDINAL method, EVALUATION, CHILDREN
Abstract

Objectives: Planned treatment interruption (PTI) of antiretroviral therapy (ART) in adults is associated with adverse outcomes. The PENTA 11 trial randomized HIV‐infected children to continuous ART (CT) vs. CD4‐driven PTIs. We report 5 years' follow‐up after the end of main trial. Methods: Post‐trial, all children resumed ART. Clinical, immunological, virological and treatment data were collected annually. A sub‐study investigated more detailed immunophenotype. CT and PTI arms were compared using intention‐to‐treat. Laboratory parameters were compared using linear regression, adjusting for baseline values; mixed models were used to include all data over time. Results: In all, 101 children (51 CT, 50 PTI) contributed a median of 7.6 years, including 5.1 years of post‐trial follow‐up. Post‐trial, there were no deaths, one pulmonary tuberculosis and no other CDC stage B/C events. At 5 years post‐trial, 90% of children in the CT vs. 82% in the PTI arm had HIV RNA < 50 copies/mL (P = 0.26). A persistent increase in CD8 cells was observed in the PTI arm. The sub‐study (54 children) suggested that both naïve and memory populations contributed to higher CD8 cells following PTI. Mean CD4/CD8 ratios at 5 years post‐trial were 1.22 and 1.08 in CT and PTI arms, respectively [difference (CT – PTI) = −0.15; 95% CI: −0.34–0.05), P = 0.14]. The sub‐study also suggested that during the trial and at early timepoints after the end of the trial, reduction in CD4 in the PTI arm was mainly from loss of CD4 memory cells. Conclusions: Children tolerated PTI with few long‐term clinical, virological or immunological consequences. [ABSTRACT FROM AUTHOR]

Published
2021
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4. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial

Author

Turkova, A, Moore, Cl, Butler, K, Compagnucci, A, Saidi, Y, Musiime, V, Nanduudu, A, Kaudha, E, Cressey, Tr, Chalermpantmetagul, S, Scott, K, Harper, L, Montero, S, Riault, Y, Bunupuradah, T, Volokha, A, Flynn, Pm, Bologna, R, Ramos Amador JT, Welch, Sb, Nastouli, E, Klein, N, Giaquinto, C, Ford, D, Babiker, A, Gibb, Dm, and Brather Penta 16 Trial Group

Subjects
Cyclopropanes, RNA viruses, Male, Genetics and Molecular Biology (all), Pulmonology, HIV Infections, Pathology and Laboratory Medicine, Toxicology, Adolescents, Biochemistry, Families, Immunodeficiency Viruses, Medicine and Health Sciences, Public and Occupational Health, Child, Children, Viral Load, Vaccination and Immunization, Adolescent, Benzoxazines, Drug Administration Schedule, Female, Follow-Up Studies, HIV-1, Humans, Reverse Transcriptase Inhibitors, Treatment Outcome, Young Adult, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Medical Microbiology, Research Design, Alkynes, Viral Pathogens, Viruses, Medicine, Pathogens, Research Article, Clinical Research Design, Science, Immunology, Antiretroviral Therapy, Research and Analysis Methods, Microbiology, Antiviral Therapy, Virology, Retroviruses, Microbial Pathogens, Toxicity, Lentivirus, Organisms, Biology and Life Sciences, HIV, Age Groups, People and Places, Respiratory Infections, Population Groupings, Preventive Medicine, Adverse Events, Viral Transmission and Infection
Abstract

BackgroundWeekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks. Planned follow-up was extended to 144 weeks, maintaining original randomisation.MethodsBREATHER was an open-label, non-inferiority trial. Participants aged 8-24yrs with virological suppression on efavirenz-based first-line ART were randomised 1:1, stratified by age and African/non-African sites, to remain on CT or change to SCT. The Kaplan-Meier method was used to estimate the proportion of participants with viral rebound (confirmed VL≥50 copies/mL) under intent-to-treat at 48 weeks (primary outcome), and in extended follow-up at 96, 144, and 192 weeks. SCT participants returned to CT following viral rebound, 3 VL blips or discontinuation of efavirenz.FindingsOf 199 participants (99 SCT, 100 CT), 97 per arm consented to extended follow-up. Median follow-up was 185.3 weeks (IQR 160.9-216.1). 69 (70%) SCT participants remained on SCT at last follow-up. 105 (53%) were male, baseline median age 14 years (IQR 12-18), median CD4 count 735 cells/μL (IQR 576-968). 16 SCT and 16 CT participants had confirmed VL≥50 copies/mL by the end of extended follow-up (HR 1.00, 95% CI 0.50-2.00). Estimated difference in percentage with viral rebound (SCT minus CT) by week 144 was 1.9% (90% CI -6.6-10.4; p = 0.72) and was similar in a per-protocol analysis. There were no significant differences between arms in proportions of participants with grade 3/4 adverse events (18 SCT vs 16 CT participants; p = 0.71) or ART-related adverse events (10 vs 12; p = 0.82). 20 versus 8 serious adverse events (SAEs) were reported in 16 SCT versus 4 CT participants, respectively (p = 0.005 comparing proportions between groups; incidence rate ratio 2.49, 95%CI 0.71-8.66, p = 0.15). 75% of SAEs (15 SCT, 6 CT) were hospitalisations for a wide range of conditions. 3 SCT and 6 CT participants switched to second-line ART following viral failure (p = 0.50).ConclusionsSustainable non-inferiority of virological suppression in young people was shown for SCT versus CT over median 3.6 years. Standard-dose efavirenz-based SCT is a viable option for virologically suppressed HIV-1 infected young people on first-line ART with 3-monthly VL monitoring.Trial registrationEudraCT 2009-012947-40 ISRCTN 97755073 ClinicalTrials.gov NCT01641016.

Published
2018

5. Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions

Author

Bunupuradah, T., Duong, T., Compagnucci, A., McMaster, P., Bernardi, S., Kanjanavanit, S., Rampon, O., Faye, A., Saidi, Y., Riault, Y., Rossi, A. de, Klein, N., Ananworanich, J., Gibb, D., Burger, D.M., and Groot, R. de

Subjects
CD4-Positive T-Lymphocytes, Male, ART re-initiation, Disease, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, HIV Seropositivity, Immunology and Allergy, 030212 general & internal medicine, Child, 0303 health sciences, treatment interruption, antiretroviral therapy, ART re-initiation, HIV-infected children, PTI, treatment interruption, Viral Load, Thailand, 3. Good health, Europe, Treatment Outcome, Infectious Diseases, Disease Progression, PTI, RNA, Viral, Female, Risk assessment, Poverty-related infectious diseases Infectious diseases and international health [N4i 3], Viral load, Cart, medicine.medical_specialty, Adolescent, Anti-HIV Agents, antiretroviral therapy, Immunology, Risk Assessment, Auto-immunity, transplantation and immunotherapy [N4i 4], Drug Administration Schedule, 03 medical and health sciences, Internal medicine, medicine, Humans, Acquired Immunodeficiency Syndrome, 030306 microbiology, business.industry, HIV-infected children, Antiretroviral therapy, United States, Confidence interval, Surgery, Treatment interruption, Relative risk, DNA, Viral, business, Follow-Up Studies
Abstract

Item does not contain fulltext BACKGROUND: Excess risks for death/opportunistic disease in adults randomized to CD4-driven planned treatment interruption (PTI) in the Strategies for Management of Antiretroviral Therapy (SMART) trial remained after antiretroviral therapy (ART) re-initiation. Risks for children following PTI were evaluated in long-term follow-up of children in the PENTA 11 trial. METHODS: Children with HIV RNA below 50 copies/ml and CD4 at least 30% (2-6 years) or at least 500 cells/mul (7-15 years) were randomized to continuous ART (cART) or PTI in PENTA 11 (ISRCTN 36694210). After the end of the trial, all were recommended to resume ART. Data were collected annually and analysed up to the second year of visit. RESULTS: One hundred and one (51 cART, 50 PTI; median baseline age 9.2 years) children had median overall follow-up 4.6 (range 3.7-5.0) years. During 2-year post-trial period, there were no deaths or new Centers for Disease Control and Prevention (CDC) stage B/C events. Rate of clinical grade of at least two events was similar between PTI and cART [relative risk (RR) 1.03; 95% confidence interval (CI) 0.43, 2.50; P = 0.94]. At 2 years, difference in absolute CD4% between PTI and cART was -1.6% (-4.5%; 1.3%; P = 0.27), and proportions with HIV RNA below 50 copies/ml were 82 versus 86% (P = 0.57), respectively; no differences in growth or fasting lipids were observed. Key predictors of greater CD4% recovery after re-initiating ART were higher CD4% at baseline (P < 0.001) and longer time since ART re-initiation (P < 0.001). During overall follow-up, 4 (8%) PTI versus 5 (10%) CT children switched ART for failure (P = 0.75) and 9 (18%) versus 1 (2%) (P = 0.008) substituted ART for simplification. CONCLUSIONS: No adverse clinical, immunological or virological consequences of PTI were observed 2 years after the end of PENTA 11 trial. Although ART interruption is not generally recommended, it may be an acceptable option for children, particularly when there is high risk of unplanned treatment interruptions.

Published
2013
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6. Neurocognition and quality of life after reinitiating antiretroviral therapy in children randomized to planned treatment interruption

Author

Ananworanich, J, Melvin, D, Amador, Jt, Childs, T, Medin, G, Boscolo, V, Compagnucci, A, Kanjanavanit, S, Montero, S, Gibb, Dm, PENTA 11 Study Group including Aboulker, J, Babiker, A, Belfrage, E, Bernardi, S, Bologna, R, Burger, D, Butler, K, Castelli Gattinara, G, Castro, H, Clayden, P, Cressey, T, Darbyshire, Jh, Debré, M, de Groot, R, della Negra, M, di Biagio, A, De Rossi, A, Duicelescu, D, Faye, A, Giaquinto, C, Giacomet, V, Grosch Wörner, I, Hainault, M, Klein, N, Lallemant, M, Levy, J, Lyall, H, Marczynska, M, Marques, L, Mardarescu, M, Mellado Peña MJ, Nadal, D, Nastouli, E, Naver, L, Niehues, T, Peckham, C, Pillay, D, Popieska, J, Ramos Amador JT, Rojo Conejo, P, Rosado, L, Rosso, R, Rudin, C, Scherpbier, Hj, Sharland, M, Stevanovic, M, Thorne, C, Tovo, Pier Angelo, Tudor Williams, G, Turkova, A, Valerius, N, Volokha, A, Walker, As, Welch, S, Wintergerst, U, Aboulker, Jp, Burger, Dm, Green, H, Harper, L, Mofenson, L, Moye, J, Saïdi, Y, Cressey, Tr, Jacqz Aigrain, E, Khoo, S, Regazzi, M, Tréluyer, Jm, Ngo Giang Huong, N, Muñoz Fernandez MA, Hill, C, Lepage, P, Pozniak, A, Vella, S, Chêne, G, Vesikari, T, Hadjou, G, Léonardo, S, Riault, Y, Bleier, J, Buck, L, Duong, T, Farrelly, L, Forcat, S, Harrison, L, Horton, J, Johnson, D, Taylor, C, Chalermpantmetagul, S, Peongjakta, R, Khamjakkaew, W, Than in at, K, Chailert, S, Jourdain, G, Le Coeur, S, Floret, D, Costanzo, P, Le Thi TT, Monpoux, F, Mellul, S, Caranta, I, Boudjoudi, N, Firtion, G, Denon, M, Charlemaine, E, Picard, F, Hellier, E, Heuninck, C, Damond, F, Alexandre, G, Tricoire, J, Antras, M, Lachendowier, C, Nicot, F, Krivine, A, Rivaux, D, Notheis, G, Strotmann, G, Schlieben, S, Rampon, O, Zanchetta, M, Ginocchio, F, Viscoli, C, Martino, A, Pontrelli, G, Baldassar, S, Concato, C, Mazza, A, Rossetti, G, Dobosz, S, Oldakowska, A, Popielska, J, Kaflik, M, Stanczak, J, Stanczack, G, Dyda, T, Kruk, M, González Tomé MI, Delgado García, R, Fernandez Gonzalez MT, Mellado Peña, M, Martín Fontelos, P, Garcia Mellado MI, Medina, Af, Ascencion, B, Garcia Bermejo, I, Navarro Gomez DM, Saavedra, J, Prieto, C, Jimenez, Jl, Garcia Torre, A, de José Gómez MI, García Rodriguez MC, Moreno Pérez, D, Núñez Cuadros, E, Asensi Botet, F, Otero Reigada, C, Pérez Tamarit MD, Vilalta, R, Molina Moreno JM, Rainer, T, Schupbach, J, Rutishauser, M, Bunupuradah, T, Butterworth, O, Phasomsap, C, Prasitsuebsai, W, Chuanjaroen, T, Jupimai, T, Ubolyam, S, Phanuphak, P, Puthanakit, T, Pancharoen, C, Mai, C, Namwong, T, Punsakoon, W, Payakachat, S, Chutima, D, Raksasang, M, Foster, C, Hamadache, D, Campbell, S, Newbould, C, Monrose, C, Abdulla, A, Walley, A, Patel, D, Kaye, S, Seery, P, Rankin, A, Wildfire, A, Novelli, V, Shingadia, D, Moshal, K, Flynn, J, Clapson, M, Allen, A, Spencer, L, Rackstraw, C, Ward, B, Parkes, K, Depala, M, Jacobsen, M, Poulsom, H, Barkley, L, Miah, J, Lurie, P, Keane, C, Mcmaster, P, Phipps, M, Orendi, J, Farmer, C, Liebeschuetz, S, Sodeinde, O, Wong, S, Bostock, V, Heath, Y, Scott, S, Gandhi, K, Lewis, P, Daglish, J, Miles, K, Summerhill, L, Subramaniam, B, Weiner, L, Famiglietti, M, Rana, S, Yu, P, Roa, J, Puga, A, Haerry, A., AII - Amsterdam institute for Infection and Immunity, Paediatric Infectious Diseases / Rheumatology / Immunology, and Global Health

Subjects
0301 basic medicine, Male, Pediatrics, medicine.medical_specialty, antiretroviral therapy, children, HIV, neurocognition, neurodevelopment, quality of life, treatment interruption, Immunology and Allergy, Immunology, Infectious Diseases, Adolescent, lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], Antiretroviral Therapy, HIV Infections, Standard score, 03 medical and health sciences, 0302 clinical medicine, Cognition, Acquired immunodeficiency syndrome (AIDS), Antiretroviral Therapy, Highly Active, Memory span, Medicine, Humans, Highly Active, 030212 general & internal medicine, Child, Wechsler Intelligence Scale for Children, business.industry, Wechsler Adult Intelligence Scale, medicine.disease, 030112 virology, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Treatment Outcome, Anti-Retroviral Agents, Test score, Mann–Whitney U test, Quality of Life, Female, business, Neurocognitive
Abstract

Item does not contain fulltext OBJECTIVE: Understanding the effects of antiretroviral treatment (ART) interruption on neurocognition and quality of life (QoL) are important for managing unplanned interruptions and planned interruptions in HIV cure research. DESIGN: Children previously randomized to continuous (continuous ART, n = 41) vs. planned treatment interruption (PTI, n = 47) in the Pediatric European Network for Treatment of AIDS (PENTA) 11 study were enrolled. At study end, PTI children resumed ART. At 1 and 2 years following study end, children were assessed by the coding, symbol search and digit span subtests of Wechsler Intelligence Scale for Children (6-16 years old) or Wechsler Adult Intelligence Scale (>/=17 years old) and by Pediatrics QoL questionnaires for physical and psychological QoL. Transformed scaled scores for neurocognition and mean standardized scores for QoL were compared between arms by t-test and Mann-Whitney U test, respectively. Scores indicating clinical concern were compared (

Published
2016

7. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial

Author

Butler, K, Turkova, A, Inshaw, J, Compagnucci, A, Kenny, J, Saidi, Y, Musiime, V, Nanduudu, A, Cressey, Tm, Chalermpantmetagul, Ks, Harper, L, Montero, S, Riault, Y, Bunupuradah, T, Volokha, A, Flynn, Pm, Bologna, R, Kizito, H, Ramos, Jt, Nastouli, E, Klein, N, Giaquinto, Carlo, Ford, D, Babiker, A, Gibb, Dm, and on behalf of the BREATHER trial team

Subjects
Infectious Diseases, Epidemiology, Immunology, Virology
Published
2016

8. Using CD4 percentage and age to optimize pediatric antiretroviral therapy initiation

Author

Yin, D.E., Warshaw, M.G., Miller, W.C., Castro, H., Fiscus, S.A., Harper, L.M., Harrison, L.J., Klein, N.J., Lewis, J., Melvin, A.J., Tudor Williams, G., Mckinney, R.E., Brouwers, P., Costello, D., Ferguson, E., Fiscus, S., Hodge, J., Hughes, M., Jennings, C., Melvin, A., Mckinney, R., Mofenson, L., Warshaw, M., Smith, M., Spector, S., Stiehm, E., Toye, M., Yogev, R., Babiker, A., Compagnucci, A., De Rossi, A., Giaquinto, C., Darbyshire, J., Debré, M., Gibb, D., Harper, L., Harrison, L., Klein, N., Pillay, D., Saidi, Y., Walker, A., Brody, B., Hill, C., Lepage, P., Modlin, J., Poziak, A., Rein, M., Robb, M., Fleming, T., Vella, S., Kim, K., Bologna, R., Mecikovsky, D., Pineda, N., Sen, L., Mangano, A., Marino, S., Galvez, C., Deluchi, G., Zöhrer, B., Zenz, W., Daghofer, E., Pfurtscheller, K., Pabst, B., Gomez, M., Mcneil, P., Jervis, M., Whyms, I., Kwolfe, D., Scott, S., Mussi Pinhata MM, Issac, M., Cervi, M., Negrini, B., Matsubara, T., de Souza CB, Gabaldi, J., Oliveira, R., Sapia, M., Abreu, T., Evangelista, L., Pala, A., Fernandes, I., Farias, I., Melo M, D.F., Carreira, H., Lira, L., Della Negra, M., Queiroz, W., Lian, Y., Pacola, D., Pinto, J., Ferreira, F., Kakehasi, F., Martins, L., Diniz, A., Lobato, V., Diniz, M., Cleto, S., Costa, S., Romeiro, J., Dollfus, C., Tabone, M., Courcoux, M., Vaudre, G., Dehée, A., Schnuriger, A., Le Gueyades, N., De Bortoli, C., Méchinaud, F., Reliquet, V., Arias, J., Rodallec, A., André, E., Falconi, I., Le Pelletier, A., Monpoux, F., Cottalorda, J., Mellul, S., Lachassinne, E., Galimand, J., Rouzioux, C., Chaix, M., Benabadji, Z., Pourrat, M., Firtion, G., Rivaux, D., Denon, M., Boudjoudi, N., Nganzali, F., Krivine, A., Méritet, J., Delommois, G., Norgeux, C., Guérin, C., Floch, C., Marty, L., Hichou, H., Tournier, V., Faye, A., Le Moal, I., Sellier, M., Dehache, L., Damond, F., Leleu, J., Beniken, D., Alexandre Castor, G., Neubert, J., Niehues, T., Laws, H., Huck, K., Gudowius, S., Siepermann, K., Loeffler, H., Bellert, S., Ortwin, A., Notheis, G., Wintergerst, U., Hoffman, F., Werthmann, A., Seyboldt, S., Schneider, L., Bucholz, B., Feiterna Sperling, C., Peiser, C., Nickel, R., Schmitz, T., Piening, T., Müller, C., Warncke, G., Wigger, M., Neubauer, R., Butler, K., Chong, A., Boulger, T., Menon, A., O'Connell, M., Barrett, L., Rochford, A., Goode, M., Hayes, E., Mcdonagh, S., Walsh, A., Doyle, A., Fanning, J., O'Connor, M., Byrne, M., O'Sullivan, N., Hyland, E., Giacomet, V., Viganò, A., Colombo, I., Trabattoni, D., Berzi, A., Badolato, R., Schumacher, F., Bennato, V., Brusati, M., Sorlini, A., Spinelli, E., Filisetti, M., Bertulli, C., Rampon, O., Zanchetta, M., Mazza, A., Stringari, G., Rossetti, G., Bernardi, S., Martino, A., Castelli Gattinara, G., Palma, P., Pontrelli, G., Tchidjou, H., Furcas, A., Frillici, C., Mazzei, A., Zoccano, A., Concato, C., Duiculescu, D., Oprea, C., Tardei, G., Abaab, F., Mardarescu, M., Draghicenoiu, R., Otelea, D., Alecsandru, L., Matusa, R., Rugina, S., Ilie, M., Netescu, S., Florea, C., Voicu, E., Poalelungi, D., Belmega, C., Vladau, L., Chiriac, A., Ramos Amador JT, Gonzalez Tomé MI, Rojo Conejo, P., Fernandez, M., Delgado Garcia, R., Ferrari, J., Garcia Lopez, M., Mellado Peña MJ, Martin Fontelos, P., Jimenez Nacher, I., Muñoz Fernandez MA, Jimenez, J., García Torre, A., Penin, M., Pineiro Perez, R., Garcia Mellado, I., Finn, A., Lajeunesse, M., Hutchison, E., Usher, J., Ball, L., Dunn, M., Sharland, M., Doerholt, K., Storey, S., Donaghy, S., Chakraborty, R., Wells, C., Buckberry, K., Rice, P., Mcmaster, P., Butler, P., O'Connell C, R., Shenton, J., Haley, H., Orendi, J., Stroobant, J., Navarante, L., Archer, P., Mazhude, C., Scott, D., O'Connell, R., Wong, J., Boddy, G., Shackley, F., Lakshman, R., Hobbs, J., Ball, G., Kudesia, G., Bane, J., Painter, D., Sloper, K., Shah, V., Cheng, A., Aali, A., Ball, C., Hawkins, S., Nayagam, D., Waters, A., Doshi, S., Liebeschuetz, S., Sodiende, B., Shingadia, D., Wong, S., Swan, J., Shah, Z., Collinson, A., Hayes, C., King, J., O'Connor, K., Lyall, H., Fidler, K., Walters, S., Foster, C., Hamadache, D., Newbould, C., Monrose, C., Campbell, S., Yeung, S., Cohen, J., Martinez Allier, N., Melvin, D., Dodge, J., Welch, S., Tatum, G., Gordon, A., Kaye, S., Muir, D., Patel, D., Novelli, V., Moshal, K., Lambert, J., Flynn, J., Farrelly, L., Clapson, M., Spencer, L., Depala, M., Jacobsen, M., Segal, S., Pollard, A., Kelly, D., Yeadon, S., Ohene Kena, B., Peng, Y., Dong, T., Jeffries, K., Snelling, M., Smyth, A., Smith, J., Ward, B., Jungmann, E., Ryan, C., Swaby, K., Buckton, A., Smit, E., Abrams, E., Champion, S., Fernandez, A., Calo, D., Garrovillo, L., Swaminathan, K., Alford, T., Frere, M., Navarra, J., Borkowsky, W., Deygoo, S., Hastings, T., Akleh, S., Ilmet, T., Mohan, K., Bowen, G., Emmanuel, P., Lujan Zimmerman, J., Rodriguez, C., Johnson, S., Marion, A., Graisbery, C., Casey, D., Lewis, G., Guzman Cottrill, J., Croteau, R., Acevedo Flores, M., Gonzalez, M., Angeli, L., Fabregas, L., Valentin, P., Weiner, L., Contello, K., Holz, W., Butler, M., Nachman, S., Kelly, M., Ferraro, D., Rana, S., Reed, C., Yeagley, E., Malheiro, A., Roa, J., Neely, M., Kovacs, A., Homans, J., Rodriguez Lozano, Y., Puga, A., Talero, G., Sellers, R., Lawrence, R., Weinberg, G., Murante, B., Laverty, S., Deveikis, A., Batra, J., Chen, T., Michalik, D., Deville, J., Elkins, K., Marks, S., Jackson Alvarez, J., Palm, J., Fineanganofo, I., Keuth, M., Deveikis, L., Tomosada, W., Van Dyke, R., Alchediak, T., Silio, M., Borne, C., Bradford, S., Eloby Childress, S., Nguyen, K., Rathore, M., Alvarez, A., Mirza, A., Mahmoudi, S., Burke, M., Febo, I., Lugo, L., Santos, R., Church, J., Dunaway, T., Rodier, C., Flynn, P., Patel, N., Discenza, S., Donohoe, M., Luzuriaga, K., Picard, D., Kline, M., Paul, M., Shearer, W., Mcmullen, C., Chadwick, E., Cagwin, E., Kabat, K., Dieudonne, A., Palumbo, P., Johnson, J., Gaur, S., Cerracchio, L., Foca, M., Jurgrau, A., Vasquez Bonilla, S., Silva, G., Gershon, A., Sullivan, J., Bryson, Y., Frenkel, L., Nelson, J., Aboulker, J., Hadjou, G., Léonardo, S., Riault, Y., Saïdi, Y., Buck, L., Forcat, S., Horton, J., Johnson, D., Moore, S., Taylor, C., Collins, D., Buskirk, S., Kamara, P., Nesel, C., Johnson, M., Ferreira, A., Tutko, J., Sprenger, H., Britto, P., Powell, C., Dersimonian, R., Handelsman, E., Ananworanich, J., Belfrage, E., Blanche, S., Bohlin, A., Burger, D., Clayden, P., De Groot, R., Di Biagio, A., Grosch Wörner, I., Hainault, M., Lallemant, M., Levy, J., Marczynska, M., Mellado Pena MJ, Nadal, D., Naver, L., Peckham, C., Popieska, J., Rosado, L., Rosso, R., Rudin, C., Scherpbier, H., Stevanovic, M., Thorne, C., Tovo, P., Valerius, N., Poole, C., Cole, S., and Mcculloh, R.J.

Subjects
CD4-Positive T-Lymphocytes, Male, medicine.medical_treatment, HIV (FISIOLOGIA), lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Treatment failure, Settore BIO/13 - Biologia Applicata, Antiretroviral Therapy, Highly Active, immunologic, Child, HIV, child, reconstitution, treatment failure, Adolescent, Anti-HIV Agents, CD4 Lymphocyte Count, Child, Preschool, Female, Follow-Up Studies, HIV-1, Humans, Infant, Infant, Newborn, Follow up studies, Immunosuppression, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Antiretroviral Therapy, World health, Article, Internal medicine, medicine, Highly Active, Preschool, Settore MED/04 - Patologia Generale, business.industry, Disease progression, Settore MED/46 - Scienze Tecniche di Medicina di Laboratorio, Newborn, Antiretroviral therapy, Confidence interval, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Immunologic, Reconstitution, Pediatrics, Perinatology and Child Health, Immunology, business
Abstract

BACKGROUND: Quantifying pediatric immunologic recovery by highly active antiretroviral therapy (HAART) initiation at different CD4 percentage (CD4%) and age thresholds may inform decisions about timing of treatment initiation. METHODS: HIV-1-infected, HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1. Data from 162 vertically infected children, with at least World Health Organization “mild” immunosuppression and CD4% RESULTS: Seventy-two percent of baseline immunosuppressed children recovered to normal within 4 years. Compared with “severe” immunosuppression, more children with “mild” immunosuppression (difference 36%, 95% confidence interval [CI]: 22% to 49%) or “advanced” immunosuppression (difference 20.8%, 95% CI: 5.8% to 35.9%) recovered a normal CD4%. For each 5-year increase in baseline age, the proportion of children achieving a normal CD4% declined by 19% (95% CI: 11% to 27%). Combining baseline CD4% and age effects resulted in >90% recovery when initiating HAART with “mild” immunosuppression at any age or “advanced” immunosuppression at age CONCLUSIONS: Initiating HAART at higher CD4% and younger ages maximizes potential for immunologic recovery. Guidelines should weigh immunologic benefits against long-term risks.

Published
2014

9. The immunological and virological consequences of planned treatment interruptions in children with HIV infection

Author

Klein, Nigel, Sefe, Delali, Mosconi, Ilaria, Zanchetta, Marisa, Castro, Hannah, Jacobsen, Marianne, Jones, Hannah, Bernardi, Stefania, Pillay, Deenan, Giaquinto, Carlo, Walker, A. Sarah, Gibb, Diana M., De Rossi, Anita, Paediatric, European Network for Treatment of AIDS 11 Trial Team including Aboulker JP, Ananworanich, J, Babiker, A, Belfrage, E, Bernardi, S, Blanche, S, Bohlin, Ab, Bologna, R, Burger, Dm, Butler, K, Castelli Gattinara, G, Castro, H, Clayden, P, Compagnucci, A, Darbyshire, Jh, Debré, M, Faye, A, de Groot, R, della Negra, M, Duiculescu, D, Giaquinto, C, Gibb, Dm, Grosch Wörner, I, Hainault, M, Harper, L, Klein, N, Lallemant, M, Levy, J, Lyall, H, Marczynska, M, Mardarescu, M, Mellado Peña, Mj, Nadal, D, Niehues, T, Peckham, C, Pillay, D, Ramos Amador, Jt, Rosado, L, Rosso, R, Rudin, C, Saidi, Y, Scherpbier, Hj, Sharland, M, Stevanovic, M, Thorne, C, Tovo, Pier Angelo, Tudor Williams, G, Valerius, N, Walker, As, Welch, S, Wintergerst, U, Aboulker, Jp, Mofenson, L, Moye, J, Saïdi, Y, Cressey, Tr, Jacqz Aigrain, E, Khoo, S, Tréluyer, Jm, De Rossi, A, Ngo Giang Huong, N, Muñoz Fernandez, Ma, Hill, C, Lepage, P, Pozniak, A, Vella, S, Hadjou, G, Léonardo, S, Riault, Y, Buck, L, Farrelly, L, Forcat, S, Harrison, L, Horton, J, Johnson, D, Moore, S, Taylor, C, Chalermpantmetagul, S, Peongjakta, R, Chailert, S, Fregonese, F, Jourdain, G, Butler, D, Carlton, C, Collins, D, Kao, G, Van Buskirk, S, Watson, S, Corradini, S, Floret, D, Le Thi, Tt, Monpoux, F, Cottalorda, J, Lefebvre, Jc, Mellul, S, Boudjoudi, N, Firtion, G, Denon, M, Picard, F, Beniken, D, Damond, F, Alexandre, G, Tricoire, J, Nicot, F, Krivine, A, Rivaux, D, Chaix, Ml, Notheis, G, Strotmann, G, Schlieben, S, Rampon, O, Zanchetta, M, Ginocchio, F, Viscoli, C, Martino, A, Pontrelli, G, Concato, C, Mazza, A, Rossetti, G, Dobosz, S, Oldakowska, A, Popielska, J, Kaflik, M, Stanczak, J, Stanczack, G, Dyda, T, González Tomé, Mi, Delgado García, R, Fernandez Gonzalez, Mt, Martín Fontelos, P, Piñeiro Pérez, R, Penin, M, Garcia Mellado, I, Medina, Af, Ascencion, B, Garcia Bermejo, I, Garcia Vela, Ja, Martin Rubio, I, Gurbindo, D, Navarro Gomez, Ml, Jimenez, Jl, Garcia Torre, A, José Gómez, Mi, García Rodriguez, Mc, Moreno Pérez, D, Núñez Cuadros, E, Asensi Botet, F, Pérez, A, Pérez Tamarit, Md, Gobernado Serrano, M, Gonzales Molina, A, Kalhert, C, Dobrovoljac, M, Berger, C, Nobile, G, Reinhard, S, Schupbach, J, Bunupuradah, T, Puthanakit, T, Pancharoen, C, Butterworth, O, Phasomsap, C, Jupimai, T, Ubolyam, S, Phanuphak, P, Mai, C, Kanjanavanit, S, Namwong, T, Chutima, D, Raksasang, M, Foster, C, Hamadache, D, Campbell, S, Newbould, C, Monrose, C, Patel, D, Kaye, S, Seery, P, Wildfire, A, Novelli, V, Shingadia, D, Moshal, K, Flynn, J, Clapson, M, Allen, A, Spencer, L, Depala, M, Jacobsen, M, Mcmaster, P, Phipps, M, Orendi, J, Farmer, C, Liebeschuetz, S, Sodeinde, O, Wong, S, Heath, Y, Scott, S, Gandhi, K, Lewis, P, Daglish, J, Weiner, L, Famiglietti, M, Rana, S, Yu, P, Roa, J, Puga, A, Haerry, A, and Inma, A.

Subjects
CD31, Genetics and Molecular Biology (all), CD4-Positive T-Lymphocytes, Time Factors, T-CELL RECONSTITUTION, ACTIVE ANTIRETROVIRAL THERAPY, STRUCTURED TREATMENT INTERRUPTION, T-CELL RECONSTITUTION, HIV-1-INFECTED CHILDREN, IMMUNE RECONSTITUTION, THYMIC OUTPUT, 1-INFECTED CHILDREN, Adolescent, Anti-Retroviral Agents, CD8-Positive T-Lymphocytes, Child, Child, Preschool, Drug Administration Schedule, HIV Infections, Humans, Immunophenotyping, Lymphocyte Count, Treatment Outcome, Viral Load, Agricultural and Biological Sciences (all), Biochemistry, Genetics and Molecular Biology (all), Medicine (all), Biochemistry, law.invention, IMMUNE RECONSTITUTION, 0302 clinical medicine, Randomized controlled trial, law, 030212 general & internal medicine, HIV-1-INFECTED CHILDREN, 0303 health sciences, Multidisciplinary, ACTIVE ANTIRETROVIRAL THERAPY, 3. Good health, Medicine, Off Treatment, Poverty-related infectious diseases Infectious diseases and international health [N4i 3], THYMIC OUTPUT, Viral load, Research Article, Science, 1-INFECTED CHILDREN, Auto-immunity, transplantation and immunotherapy [N4i 4], 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), medicine, Preschool, 030304 developmental biology, business.industry, medicine.disease, Clinical trial, Immunology, STRUCTURED TREATMENT INTERRUPTION, business, CD8
Abstract

Contains fulltext : 126098.pdf (Publisher’s version ) (Open Access) OBJECTIVES: To evaluate the immunological and viral consequences of planned treatment interruptions (PTI) in children with HIV. DESIGN: This was an immunological and virological sub-study of the Paediatric European Network for Treatment of AIDS (PENTA) 11 trial, which compared CD4-guided PTI of antiretroviral therapy (ART) with continuous therapy (CT) in children. METHODS: HIV-1 RNA and lymphocyte subsets, including CD4 and CD8 cells, were quantified on fresh samples collected during the study; CD45RA, CD45RO and CD31 subpopulations were evaluated in some centres. For 36 (18 PTI, 18 CT) children, immunophenotyping was performed and cell-associated HIV-1 DNA analysed on stored samples to 48 weeks. RESULTS: In the PTI group, CD4 cell count fell rapidly in the first 12 weeks off ART, with decreases in both naive and memory cells. However, the proportion of CD4 cells expressing CD45RA and CD45RO remained constant in both groups. The increase in CD8 cells in the first 12 weeks off ART in the PTI group was predominantly due to increases in RO-expressing cells. PTI was associated with a rapid and sustained increase in CD4 cells expressing Ki67 and HLA-DR, and increased levels of HIV-1 DNA. CONCLUSIONS: PTI in children is associated with rapid changes in CD4 and CD8 cells, likely due to increased cell turnover and immune activation. However, children off treatment may be able to maintain stable levels of naive CD4 cells, at least in proportion to the memory cell pool, which may in part explain the observed excellent CD4 cell recovery with re-introduction of ART.

Published
2013

10. Adherence to antiretroviral therapy and acceptability of planned treatment interruptions in HIV-infected children

Author

Harrison, L., Ananworanich, J., Hamadache, D., Compagnucci, A., Penazzato, M., Bunupuradah, T., Mazza, A., Ramos, J.T., Flynn, J., Rampon, O., Mellado Pena, M.J., Floret, D., Marczynska, M., Puga, A., Forcat, S., Riault, Y., Lallemant, M., Castro, H., Gibb, D.M., Giaquinto, C., Burger, D.M., and Groot, R. de

Subjects
Male, Pediatrics, HIV Infections, 0302 clinical medicine, Acceptability, Hiv infected, Antiretroviral Therapy, Highly Active, Surveys and Questionnaires, 030212 general & internal medicine, Child, Children, education.field_of_study, Viral Load, Thailand, 3. Good health, Europe, Infectious Diseases, Anti-Retroviral Agents, Caregivers, Planned treatment interruptions, Child, Preschool, Female, Public Health, Poverty-related infectious diseases Infectious diseases and international health [N4i 3], Developed country, Viral load, Adherence, HIV, Adolescent, CD4 Lymphocyte Count, Drug Administration Schedule, Follow-Up Studies, HIV-1, Humans, United States, Medication Adherence, Patient Acceptance of Health Care, Public Health, Environmental and Occupational Health, Social Psychology, medicine.medical_specialty, Visual analogue scale, Population, Antiretroviral Therapy, Auto-immunity, transplantation and immunotherapy [N4i 4], 03 medical and health sciences, 030225 pediatrics, medicine, Highly Active, Preschool, education, Original Paper, business.industry, Public health, Environmental and Occupational Health, Odds ratio, Antiretroviral therapy, business
Abstract

Contains fulltext : 117467.pdf (Publisher’s version ) (Open Access) There have been no paediatric randomised trials describing the effect of planned treatment interruptions (PTIs) of antiretroviral therapy (ART) on adherence, or evaluating acceptability of such a strategy. In PENTA 11, HIV-infected children were randomised to CD4-guided PTIs (n = 53) or continuous therapy (CT, n = 56). Carers, and children if appropriate, completed questionnaires on adherence to ART and acceptability of PTIs. There was no difference in reported adherence on ART between CT and PTI groups; non-adherence (reporting missed doses over the last 3 days or marking

Published
2012

11. Plasma drug concentrations and virologic evaluations after stopping treatment with nonnucleoside reverse-transcriptase inhibitors in HIV type 1-infected children

Author

Cressey, Tr, Green, H, Khoo, S, Treluyer, Jm, Compagnucci, A, Saidi, Y, Lallemant, M, Gibb, Dm, Burger, Dm, Collaborators: Aboulker JP, Paediatric European Network for Treatment of AIDS II Study G. r. o. u. p., Babiker, A, Blanche, S, Bohlin, Ab, Butler, K, Castelli Gattinara, G, Clayden, P, Darbyshire, Jh, Debré, M, de Groot, R, della Negra, M, Duicelescu, D, Giaquinto, C, Grosch Wörner, I, Kind, C, Levy, J, Lyall, H, Marczynska, M, Mellado Peña MJ, Nadal, D, Niehues, T, Peckham, C, Ramos Amador JT, Rosado, L, Rudin, C, Scherpbier, Hj, Sharland, M, Stevanovic, M, Tovo, Pier Angelo, Tudor Williams, G, Valerius, N, Walker, As, Wintergerst, U, Aboulker, Jp, Harper, L, Klein, N, Mofenson, L, Moye, J, Saïdi, Y, Jacqz Aigrain, E, Tréluyer, Jm, Clerici, M, De Rossi, A, Ngo Giang Huong, N, Muñoz Fernandez MA, Pillay, D, Hill, C, Lepage, P, Pozniak, A, Vella, S, Eliette, V, Hadjou, G, Léonardo, S, Pitrou, C, Riault, Y, Buck, L, Farrelly, L, Johnson, D, Taylor, C, Chalermpantmetagul, S, Peongjakta, R, Chailert, S, Fregonese, F, Jourdain, G, Butler, D, Carlton, C, Collins, D, Kao, G, Van Buskirk, S, Watson, S, Corradini, S, Floret, D, Laplace, J, Monpoux, F, Cottalorda, J, Lefebvre, Jc, Mellul, S, Boudjoudi, N, Firtion, G, Faye, A, Beniken, D, Damond, F, Tricoire, J, Krivine, A, Chaix, Ml, Notheis, G, Strotmann, G, Schlieben, S, Rampon, O, Zanchetta, M, Rosso, R, Repeto, E, Vitale, F, Martino, A, Bernardi, S, Mazza, A, Rossetti, G, Dobosz, S, Oldakowska, A, Popielska, J, Kaflik, M, Stanczak, J, Stanczac, T, González Tomé MI, Delgado García, R, José Mellado Peña, M, Martín Fontelos, P, Piñeiro Pérez, R, Alimenti, A, Penin, M, Gurbindo, D, Navarro Gomez ML, Jimenez, Jl, Prieto, C, de José Gómez MI, García Rodriguez MC, Moreno Pérez, D, Núñéz Cuadros, E, Asensi Botet, F, Pérez, A, Pérez Tamarit MD, Kalhert, C, Schupbach, J, Bunupuradah, T, Ananworanich, J, Phanuphak, P, Intasan, J, Ubolyam, S, Kanjanavanit, S, Namwong, T, Foster, C, Hamadache, D, Campbell, S, Hanley, C, Walsh, C, Kaye, S, Seery, P, Novelli, V, Shingadia, D, Flynn, J, Clapson, M, Jacobsen, M, Mcmaster, P, Hawkes, E, Liebeschuetz, S, Sodeinde, O, Wong, S, Walsh, S, Heath, Y, Weiner, L, Famiglietti, M, Rana, S, Yu, P, Roa, J, Puga, A, Haerry, A, Regazzi, M, Villani, S, Gibbons, S, Jullien, V, Rey, E, Treluye, Jm, Rodríguez Nóvoa, S, Tawon, Y., University of Zurich, and Green, H

Subjects
Cyclopropanes, Male, Time Factors, Infectious diseases and international health [NCEBP 13], HIV Infections, Drug resistance, Pharmacology, THERAPY, PROPHYLAXIS, 2726 Microbiology (medical), chemistry.chemical_compound, Plasma, immune system diseases, Medicine, Child, Reverse-transcriptase inhibitor, RESISTANCE, THERAPY, EXPOSURE, PHARMACOGENETICS, PROPHYLAXIS, virus diseases, Drug holiday, Viral Load, Infectious Diseases, Alkynes, Child, Preschool, Reverse Transcriptase Inhibitors, Female, Viral load, medicine.drug, Microbiology (medical), medicine.medical_specialty, Efavirenz, Nevirapine, Adolescent, CD4-CD8 Ratio, 610 Medicine & health, Article, Invasive mycoses and compromised host [N4i 2], Internal medicine, Drug Resistance, Viral, Humans, Protease inhibitor (pharmacology), EXPOSURE, PHARMACOGENETICS, business.industry, Poverty-related infectious diseases [N4i 3], 2725 Infectious Diseases, Benzoxazines, CD4 Lymphocyte Count, Regimen, chemistry, Withholding Treatment, 10036 Medical Clinic, Mutation, HIV-1, Microbial pathogenesis and host defense [UMCN 4.1], business, RESISTANCE
Abstract

Contains fulltext : 71467.pdf (Publisher’s version ) (Open Access) BACKGROUND: The optimum strategy for stopping treatment with drugs that have different half-lives in a combination regimen to minimize the risk of selecting drug-resistant viruses remains unknown. We evaluated drug concentrations in plasma, human immunodeficiency virus (HIV) load, and development of drug resistance after a planned treatment interruption of a nonnucleoside reverse-transcriptase inhibitor (NNRTI)-containing regimen in HIV type 1-infected children. METHODS: Children with viral loads or =30% (for children aged 2-6 years) or CD4 cell percentages > or =25% and CD4 cell counts > or =500 cells/microL (for children aged 7-15 years) were randomized to either a planned treatment interruption or to continuous therapy. In the planned treatment interruption arm, either (1) treatment with nevirapine or efavirenz was stopped, and treatment with the remaining drugs was continued for 7-14 days, or (2) nevirapine or efavirenz were replaced by a protease inhibitor, and all drugs were stopped after 7-14 days. Sampling for determination of plasma drug concentrations, measurement of viral load, and drug resistance testing was scheduled at day 0, day 7 (drug concentrations only), day 14, and day 28 after interruption of treatment with an NNRTI. RESULTS: Treatment with an NNRTI was interrupted for 35 children (20 were receiving nevirapine, and 15 were receiving efavirenz). Median time from NNRTI cessation to stopping all drugs was 9 days (range, 6-15 days) for nevirapine and 14 days (range, 6-18 days) for efavirenz. At 7 days, 1 (5%) of 19 and 4 (50%) of 8 children had detectable nevirapine and efavirenz concentrations, respectively; efavirenz remained detectable in 3 (25%) of 12 children at 14 days. At 14 days, viral load was > or =50 copies/mL in 6 of 16 children interrupting treatment with nevirapine (range, 52-7000 copies/mL) and in 2 of 12 children interrupting treatment with efavirenz (range, 120-1600 copies/mL). No new NNRTI mutations were observed. CONCLUSIONS: In children with virological suppression who experienced interruption of treatment with an NNRTI, staggered or replacement stopping strategies for a median of 9 days for nevirapine and 14 days for efavirenz were not associated with the selection of NNRTI resistance mutations.

Published
2008
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12. Adherence to antiretroviral therapy and acceptability of planned treatment interruptions in HIV-infected children

Author

Harrison, L., Ananworanich, J., Hamadache, D., Compagnucci, A., Penazzato, M., Bunupuradah, T., Mazza, A., Ramos, J.T., Flynn, J., Rampon, O., Mellado Pena, M.J., Floret, D., Marczynska, M., Puga, A., Forcat, S., Riault, Y., Lallemant, M., Castro, H., Gibb, D.M., Giaquinto, C., Burger, D.M., Groot, R. de, et al., Harrison, L., Ananworanich, J., Hamadache, D., Compagnucci, A., Penazzato, M., Bunupuradah, T., Mazza, A., Ramos, J.T., Flynn, J., Rampon, O., Mellado Pena, M.J., Floret, D., Marczynska, M., Puga, A., Forcat, S., Riault, Y., Lallemant, M., Castro, H., Gibb, D.M., Giaquinto, C., Burger, D.M., Groot, R. de, and et al.

Abstract

Contains fulltext : 117467.pdf (publisher's version ) (Open Access), There have been no paediatric randomised trials describing the effect of planned treatment interruptions (PTIs) of antiretroviral therapy (ART) on adherence, or evaluating acceptability of such a strategy. In PENTA 11, HIV-infected children were randomised to CD4-guided PTIs (n = 53) or continuous therapy (CT, n = 56). Carers, and children if appropriate, completed questionnaires on adherence to ART and acceptability of PTIs. There was no difference in reported adherence on ART between CT and PTI groups; non-adherence (reporting missed doses over the last 3 days or marking <100 % adherence since the last clinical visit on a visual analogue scale) was 18 % (20/111) and 14 % (12/83) on carer questionnaires in the CT and PTI groups respectively (odds ratios, OR (95 % CI) = 1.04 (0.20, 5.41), chi(2) (1) = 0.003, p = 0.96). Carers in Europe/USA reported non-adherence more often (31/121, 26 %) than in Thailand (1/73, 1 %; OR (95 % CI) = 54.65 (3.68, 810.55), chi(2) (1) = 8.45, p = 0.004). The majority of families indicated they were happy to have further PTIs (carer: 23/36, 64 %; children: 8/13, 62 %), however many reported more clinic visits during PTI were a problem (carer: 15/36, 42 %; children: 6/12, 50 %).

Published
2013

13. Simultaneous pharmacokinetic modeling of unbound and total darunavir with ritonavir in adolescents: a substudy of the SMILE trial.

Author

Abdalla S, Compagnucci A, Riault Y, Chan MK, Bamford A, Nolan A, Ramos JT, Constant V, Nguyen T-N, Zheng Y, Tréluyer J-M, Froelicher-Bournaud L, Neveux N, Saidi Y, Cressey TR, and Hirt D

Subjects
Adult, Child, Humans, Adolescent, Darunavir pharmacokinetics, Ritonavir therapeutic use, Sulfonamides pharmacology, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use
Abstract

Darunavir (DRV) is an HIV protease inhibitor commonly used as part of antiretroviral treatment regimens globally for children and adolescents. It requires a pharmacological booster, such as ritonavir (RTV) or cobicistat. To better understand the pharmacokinetics (PK) of DRV in this younger population and the importance of the RTV boosting effect, a population PK substudy was conducted within SMILE trial, where the maintenance of HIV suppression with once daily integrate inhibitor + darunavir/ritonavir in children and adolescents is evaluated. A joint population PK model that simultaneously used total DRV, unbound DRV, and total RTV concentrations was developed. Competitive and non-competitive models were examined to define RTV's influence on DRV pharmacokinetics. Linear and non-linear equations were tested to assess DRV protein binding. A total of 443 plasma samples from 152 adolescents were included in this analysis. Darunavir PK was best described by a one-compartment model first-order absorption and elimination. The influence of RTV on DRV pharmacokinetics was best characterized by ritonavir area under the curve on DRV clearance using a power function. The association of non-linear and linear equations was used to describe DRV protein binding to alpha-1 glycoprotein and albumin, respectively. In our population, simulations indicate that 86.8% of total and unbound DRV trough concentrations were above 0.55 mg/L [10 times protein binding-adjusted EC 50 for wild-type (WT) HIV-1] and 0.0243 mg/L (10 times EC 90 for WT HIV-1) targets, respectively. Predictions were also in agreement with observed outcomes from adults receiving 800/100 mg DRV/r once a day. Administration of 800/100 mg of DRV/r once daily provides satisfactory concentrations and exposures for adolescents aged 12 years and older., Competing Interests: The authors declare no conflict of interest.

Published
2024
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14. Population pharmacokinetics of unbound and total dolutegravir concentrations in children aged 12 years and older: a PK substudy of the SMILE trial.

Author

Abdalla S, Compagnucci A, Zheng Y, Tréluyer JM, Saidi Y, Ramos JT, Coelho A, Riault Y, Cressey TR, and Hirt D

Subjects
Adult, Adolescent, Humans, Child, Darunavir therapeutic use, Ritonavir therapeutic use, Heterocyclic Compounds, 3-Ring therapeutic use, Oxazines therapeutic use, Pyridones therapeutic use, HIV Infections drug therapy, Anti-HIV Agents therapeutic use
Abstract

Background: SMILE, a multicentre randomized trial, compared the efficacy and safety of switching virologically suppressed children and adolescents with HIV to a once-daily dual regimen of dolutegravir plus ritonavir-boosted darunavir versus continuing standard ART. Within a nested pharmacokinetic (PK) substudy, we performed a population PK analysis to describe total and unbound dolutegravir plasma concentrations in children and adolescents receiving this dual therapy., Methods: Sparse blood samples were obtained during follow-up for dolutegravir quantification. A population PK model was developed to simultaneously describe total and unbound dolutegravir concentrations. Simulations were performed and were compared with the protein-adjusted 90% inhibitory concentration (IC90) and the in vitro IC50, respectively. Dolutegravir exposures in children aged ≥12 years were also compared with values in treatment-experienced adults., Results: Four hundred and fifty-five samples from 153 participants aged between 12 and 18 years were collected for this PK analysis. A one-compartment model with first-order absorption and elimination best described unbound dolutegravir concentrations. The relationship between unbound and total dolutegravir concentrations was best characterized by a non-linear model. Unbound dolutegravir apparent clearance was significantly influenced by total bilirubin concentrations and by Asian ethnicity. All children and adolescents had trough concentrations well above the protein-adjusted IC90 and the in vitro IC50 values. Dolutegravir concentrations and exposures were also similar to those obtained in adults receiving dolutegravir 50 mg once daily., Conclusions: A once-daily 50 mg dolutegravir dose for children and adolescents produces adequate total and unbound concentrations when used as part of dual therapy with ritonavir-boosted darunavir., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2023
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15. Adherence to antiretroviral therapy and acceptability of planned treatment interruptions in HIV-infected children.

Author

Harrison L, Ananworanich J, Hamadache D, Compagnucci A, Penazzato M, Bunupuradah T, Mazza A, Ramos JT, Flynn J, Rampon O, Mellado Pena MJ, Floret D, Marczynska M, Puga A, Forcat S, Riault Y, Lallemant M, Castro H, Gibb DM, and Giaquinto C

Subjects
Adolescent, CD4 Lymphocyte Count, Caregivers psychology, Child, Child, Preschool, Drug Administration Schedule, Europe, Female, Follow-Up Studies, HIV Infections virology, HIV-1, Humans, Male, Surveys and Questionnaires, Thailand, United States, Viral Load, Anti-Retroviral Agents administration & dosage, Antiretroviral Therapy, Highly Active methods, HIV Infections drug therapy, Medication Adherence, Patient Acceptance of Health Care
Abstract

There have been no paediatric randomised trials describing the effect of planned treatment interruptions (PTIs) of antiretroviral therapy (ART) on adherence, or evaluating acceptability of such a strategy. In PENTA 11, HIV-infected children were randomised to CD4-guided PTIs (n = 53) or continuous therapy (CT, n = 56). Carers, and children if appropriate, completed questionnaires on adherence to ART and acceptability of PTIs. There was no difference in reported adherence on ART between CT and PTI groups; non-adherence (reporting missed doses over the last 3 days or marking <100 % adherence since the last clinical visit on a visual analogue scale) was 18 % (20/111) and 14 % (12/83) on carer questionnaires in the CT and PTI groups respectively (odds ratios, OR (95 % CI) = 1.04 (0.20, 5.41), χ(2) (1) = 0.003, p = 0.96). Carers in Europe/USA reported non-adherence more often (31/121, 26 %) than in Thailand (1/73, 1 %; OR (95 % CI) = 54.65 (3.68, 810.55), χ(2) (1) = 8.45, p = 0.004). The majority of families indicated they were happy to have further PTIs (carer: 23/36, 64 %; children: 8/13, 62 %), however many reported more clinic visits during PTI were a problem (carer: 15/36, 42 %; children: 6/12, 50 %).

Published
2013
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