Document Detail


Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions.
MedLine Citation:
PMID:  23135172     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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/μl (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.
Authors:
Torsak Bunupuradah; Trinh Duong; Alexandra Compagnucci; Paddy McMaster; Stefania Bernardi; Suparat Kanjanavanit; Osvalda Rampon; Albert Faye; Yacine Saïdi; Yoann Riault; Anita De Rossi; Nigel Klein; Jintanat Ananworanich; Diana Gibb;
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  AIDS (London, England)     Volume:  27     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-31     Completed Date:  2013-08-21     Revised Date:  2014-02-20    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  579-89     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy*,  epidemiology,  immunology
Adolescent
Anti-HIV Agents / administration & dosage*
Antiretroviral Therapy, Highly Active*
CD4-Positive T-Lymphocytes / drug effects*,  immunology
Child
DNA, Viral
Disease Progression
Drug Administration Schedule
Europe / epidemiology
Female
Follow-Up Studies
HIV Seropositivity / drug therapy*,  epidemiology,  immunology
Humans
Male
RNA, Viral
Risk Assessment
Thailand / epidemiology
Treatment Outcome
United States / epidemiology
Viral Load
Grant Support
ID/Acronym/Agency:
MC_U122886353//Medical Research Council
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/DNA, Viral; 0/RNA, Viral
Investigator
Investigator/Affiliation:
J -P Aboulker / ; J Ananworanich / ; A Babiker / ; E Belfrage / ; S Bernardi / ; S Blanche / ; A -B Bohlin / ; R Bologna / ; K Butler / ; G Castelli-Gattinara / ; H Castro / ; P Clayden / ; A Compagnucci / ; J H Darbyshire / ; M Debre / ; A Faye / ; R de Groot / ; M della Negra / ; A di Biagio / ; D Duicelescu / ; A Faye / ; C Giaquinto / ; V Giacomet / ; D M Gibb / ; I Grosch-Worner / ; M Hainault / ; M Lallemant / ; J Levy / ; H Lyall / ; M Marczynska / ; M Mardarescu / ; M J Mellado Pena / ; D Nadal / ; T Niehues / ; C Peckham / ; J T Ramos Amador / ; L Rosado / ; C Rudin / ; H J Scherpbier / ; M Sharland / ; M Stevanovic / ; C Thorne / ; P A Tovo / ; G Tudor-Williams / ; N Valerius / ; A S Walker / ; S Welch / ; U Wintergerst / ; J P Aboulker / ; A Babiker / ; D M Burger / ; A Compagnucci / ; J H Darbyshire / ; M Debre / ; C Giaquinto / ; D M Gibb / ; H Green / ; L Harper / ; N Klein / ; M Lallemant / ; H Lyall / ; L Mofenson / ; J Moye / ; D Nadal / ; Y Saıdi / ; D M Burger / ; T R Cressey / ; E Jacqz-Aigrain / ; S Khoo / ; M Regazzi / ; J M Treluyer / ; A De Rossi / ; N Klein / ; J Moye / ; N Ngo-Giang-Huong / ; M A Munoz Fernandez / ; D Pillay / ; C Hill / ; P Lepage / ; A Pozniak / ; S Vella / ; G Chene / ; T Vesikari / ; A Compagnucci / ; G Hadjou / ; S Leonardo / ; Y Riault / ; Y Saidi / ; A Babiker / ; J Bleier / ; L Buck / ; H Castro / ; J H Darbyshire / ; T Duong / ; L Farrelly / ; S Forcat / ; D M Gibb / ; L Harper / ; L Harrison / ; J Horton / ; D Johnson / ; S Moore / ; C Taylor / ; A S Walker / ; S Chalermpantmetagul / ; T R Cressey / ; R Peongjakta / ; W Khamjakkaew / ; K Thaninat / ; S Chailert / ; G Jourdain / ; M Lallemant / ; S Le Coeur / ; N Ngo-Giang-Huong / ; S Corradini / ; P Costanzo / ; T T Le Thi / ; F Monpoux / ; S Mellul / ; I Caranta / ; N Boudjoudi / ; G Firtion / ; M Denon / ; E Charlemaine / ; F Picard / ; A Faye / ; E Hellier / ; C Heuninck / ; F Damond / ; G Alexandre / ; J Tricoire / ; M Antras / ; C Lachendowier / ; F Nicot / ; A Krivine / ; D Rivaux / ; U Wintergerst / ; G Notheis / ; G Strotmann / ; S Schlieben / ; C Giaquinto / ; O Rampon / ; V Boscolo / ; M Zanchetta / ; R Rosso / ; F Ginocchio / ; C Viscoli / ; A di Biagio / ; G Castelli-Gattinara / ; S Bernardi / ; A Martino / ; G Pontrelli / ; S Baldassar / ; C Concato / ; A Mazza / ; V Boscolo / ; G Rossetti / ; M Marczynska / ; S Dobosz / ; A Oldakowska / ; J Popielska / ; M Kaflik / ; J Stanczak / ; G Stanczack / ; T Dyda / ; M Kruk / ; M I Gonzalez Tome / ; P Rojo Conejo / ; R Delgado Garcıa / ; M T Fernandez Gonzalez / ; G Medin / ; M Jose Mellado Pena / ; P Martın Fontelos / ; M I Garcia Mellado / ; A F Medina / ; B Ascencion / ; J T Ramos Amador / ; I Garcia Bermejo / ; M L Navarro Gomez / ; J Saavedra / ; C Prieto / ; J L Jimenez / ; M A Munoz-Fernandez / ; A Garcia Torre / ; M I de Jose Gomez / ; M C Garcıa Rodriguez / ; D Moreno Perez / ; E Nunez Cuadros / ; F Asensi-Botet / ; C Otero Reigada / ; M D Perez Tamarit / ; R Vilalta / ; Molina Moreno / ; D Nadal / ; J Schupbach / ; M Rutishauser / ; T Bunupuradah / ; J Ananworanich / ; O Butterworth / ; C Phasomsap / ; W Prasitsuebsai / ; T Chuanjaroen / ; T Jupimai / ; S Ubolyam / ; P Phanuphak / ; T Puthanakit / ; C Pancharoen / ; S Kanjanavanit / ; T Namwong / ; W Punsakoon / ; S Payakachat / ; D Chutima / ; M Raksasang / ; W Punsakoon / ; S Payakachat / ; H Lyall / ; G Tudor-Williams / ; C Foster / ; D Hamadache / ; S Campbell / ; C Newbould / ; C Monrose / ; A Abdulla / ; A Walley / ; D Melvin / ; D Patel / ; S Kaye / ; H Lyall / ; P Seery / ; D Hamadache / ; A Rankin / ; V Novelli / ; D M Gibb / ; N Klein / ; D Shingadia / ; K Moshal / ; J Flynn / ; M Clapson / ; L Farrelly / ; A Allen / ; L Spencer / ; C Rackstraw / ; B Ward / ; K Parkes / ; M Depala / ; M Jacobsen / ; H Poulsom / ; L Barkley / ; J Miah / ; D Melvin / ; P Lurie / ; C Keane / ; P McMaster / ; M Phipps / ; J Orendi / ; C Farmer / ; S Liebeschuetz / ; O Sodeinde / ; D Shingadia / ; S Wong / ; V Bostock / ; S Welch / ; Y Heath / ; S Scott / ; K Gandhi / ; P Lewis / ; J Daglish / ; K Miles / ; L Summerhill / ; D Pillay / ; B Subramaniam / ; L Weiner / ; M Famiglietti / ; S Rana / ; P Yu / ; J Roa / ; A Puga / ; A Haerry /

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