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AIDS. 2010 Jan 16;24(2):231-41. doi: 10.1097/QAD.0b013e328333d343.

Response to planned treatment interruptions in HIV infection varies across childhood.

Collaborators (271)

Gibb DM, Castro H, Compagnucci A, Klein N, Lallemant M, Lyall H, Nadal D, Ananworanich J, Babiker A, Bunupuradah T, Darbyshire JH, De Rossi A, Gonzalez Tome MI, Harper L, Kanjavanit S, Marczynska M, Mofenson L, Monpoux F, Moye J, Munoz-Fernandez MA, Ngo Giang-Huong N, Niehues T, Saidi Y, Walker AS, Wintergerst U, Giaquinto C, Aboulker JP, Babiker A, Blanche S, Bohlin AB, Butler K, Castelli-Gattinara G, Clayden P, Compagnucci A, Darbyshire JH, Debre M, Faye A, de Groot R, della Negra M, Duicelescu D, Giaquinto C, Gibb DM, Grosch-Worner I, Lallemant M, Levy J, Lyall H, Marczynska M, Mellado Pena MJ, Nadal D, Niehues T, Peckham C, Ramos Amador JT, Rosado L, Rudin C, Scherpbier HJ, Sharland M, Stevanovic M, Tovo PA, Tudor-Williams G, Valerius N, Walker AS, Wintergerst U, Aboulker JP, Babiker A, Burger DM, Compagnucci A, Darbyshire JH, Debre M, Giaquinto C, Gibb DM, Castro H, Harper L, Klein N, Lallemant M, Lyall H, Mofenson L, Moye J, Nadal D, Saidi Y, Burger DM, Cressey TR, Jacqz-Aigrain E, Khoo S, Treluyer JM, De Rossi A, Klein N, Moye J, Ngo-Giang-Huong N, Munoz Fernandez MA, Pillay D, Hill C, Lepage P, Pozniak A, Vella S, Aboulker JP, Compagnucci A, Eliette V, Hadjou G, Leonardo S, Pitrou C, Riault Y, Saidi Y, Babiker A, Buck L, Darbyshire JH, Farrelly L, Forcat S, Gibb DM, Castro H, Harper L, Harrison L, Horton J, Johnson D, Taylor C, Walker AS, Chalermpantmetagul S, Cressey TR, Peongjakta R, Chailert S, Fregonese F, Jourdain G, Lallemant M, Ngo-Giang-Huong N, Butler D, Carlton C, Collins D, Kao G, Mofenson L, Moye J, 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, Faye A, Beniken D, Damond F, Alexandre G, Tricoire J, Nicot F, Krivine A, Rivaux D, Wintergerst U, Notheis G, Strotmann G, Schlieben S, Giaquinto C, Rampon O, Zanchetta M, Rosso R, Ginocchio F, Viscoli C, Castelli-Gattinara G, Bernardi S, Martino A, Pontrelli G, Concato C, Mazza A, Rossetti G, Marczynska M, Dobosz S, Oldakowska A, Popielska J, Kaflik M, Stanczak J, Stanczack J, Dyda T, Gonzalez Tome MI, Delgado Garcia R, Fernandez Gonzalez MT, Jose Mellado Pena M, Martin-Fontelos P, Pineiro Perez R, Penin M, Garcia Mellado I, Medina AF, Ascencion B, Ramos Amador JT, Garcia Bermejo I, Garcia Vela JA, Martin Rubio I, Gurbindo D, Navarro Gomez ML, Jimenez JL, Munoz-Fernandez MA, Garcia Torre A, de Jose Gomez MI, Garcia Rodriguez MC, Moreno Perez D, Nunez Cuadros E, Asensi-Botet F, Perez A, Perez Tamarit MD, Gobernado Serrano M, Gonzales Molina A, Kalhert C, Nadal D, Dobrovoljac M, Berger C, Nobile G, Reinhard S, Schupbach J, Bunupuradah T, Ananworanich J, Butterworth O, Phasomsap C, Jupimai T, Ubolyam S, Phanuphak P, Puthanakit T, Pancharoen C, Kanjanavanit S, Namwong T, Chutima D, Raksasang M, Lyall H, Tudor-Williams G, Foster C, Hamadache D, Campbell S, Newbould C, Monrose C, Patel D, Kaye S, Lyall H, Seery P, Hamadache D, Wildfire A, Novelli V, Gibb DM, Klein N, Shingadia D, Moshal K, Flynn J, Clapson M, Farrelly L, Allen A, Spencer L, Depala M, Jacobsen M, McMaster P, Phipps M, Orendi J, Farmer C, Liebeschuetz S, Sodeinde O, Shingadia D, Wong S, Welch S, Heath Y, Scott S, Gandhi K, Lewis P, Daglish J, Pillay D, Weiner L, Famiglietti M, Rana S, Yu P, Roa J, Puga A, Haerry A, Inman A.



To evaluate clinical, immunological and virological consequences of CD4-guided antiretroviral therapy (ART) planned treatment interruptions (PTIs) compared with continuous therapy in children with chronic HIV infection in the Paediatric European Network for Treatment of AIDS 11 trial.


This was a multicentre, 72-week, open, randomized, phase II trial.


One hundred and nine children with HIV-RNA below 50 copies/ml and CD4% of at least 30% (2-6 years) or at least 25% and CD4 cell count of at least 500 cells/microl (7-15 years) were randomized to continuous therapy (53) or PTI (56). In PTI, ART was restarted if confirmed CD4% was less than 20% or more than 48 weeks had been spent off ART. The primary outcome was Centers for Disease Control and Prevention (CDC) stage C event, death or CD4% less than 15% (and CD4 cell count less than 200 cells/microl for children aged 7-15 years).


At baseline, median (interquartile range) age was 9 (6-12) years, CD4% 37% (33-41), CD4 cell count 966 (793-1258) cells/microl, nadir CD4% before combination ART 18% (10-27), time on ART 6 (3-6) years and 26% were CDC stage C. After median (range) 130 (33-180) weeks of follow-up, 4 versus 48% of time was spent off ART in continuous therapy and PTI, respectively. No child died or had a new CDC stage C event; one (2%) continuous therapy versus four (7%) PTI children had a primary outcome based on CD4%/cell count (P = 0.2). Lower nadir CD4% predicted faster CD4% decline after stopping ART. Younger age and higher nadir CD4% predicted being off ART for at least 48 weeks and better CD4% recovery following PTI.


In this first paediatric trial of PTI, there were no serious clinical outcomes. Younger children had better CD4% recovery after PTIs. Immunology substudies and long-term follow-up in Paediatric European Network for Treatment of AIDS 11 trial are ongoing. Further research into the role of treatment interruption in children is required, particularly, as guidelines now recommend early ART for all infected infants.

[Indexed for MEDLINE]

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