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

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

Research output: Contribution to journalArticlepeer-review


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

Original languageEnglish
Pages (from-to)579-589
Number of pages11
JournalAIDS (London, England)
Issue number4
Publication statusPublished - Feb 20 2013


  • antiretroviral therapy
  • ART re-initiation
  • HIV-infected children
  • PTI
  • treatment interruption

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases


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