title: Neurocognition and quality of life after reinitiating antiretroviral therapy in children randomized to planned treatment interruption.
abstract: 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.
  
  
  METHODS
  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 (<7 for neurocognition and <70 for QoL tests).
  
  
  RESULTS
  Characteristics were similar between arms with a median age of 12.6 years, CD4⁺ of 830 cells/μl and HIV RNA of 1.7 log10copies/ml. The median cumulative ART exposure was 9.6 in continuous ART vs. 7.7 years in PTI (P = 0.02). PTI children had a median of 12 months off ART and had resumed ART for 25.2 months at time of first assessment. Neurocognitive scores were similar between arms for all tests. Physical and psychological QoL scores were no different. About 40% had low neurocognitive and QoL scores indicating clinical concern.
  
  
  CONCLUSIONS
  No differences in information processing speed, sustained attention, short-term memory and QoL functioning were observed between children previously randomized to continuous ART vs. PTI in the PENTA 11 trial.
authors.affiliation: aThe HIV Netherlands Australia Thailand Research Collaboration, The Thai Red Cross AIDS Research Center, Bangkok, Thailand bImperial College Healthcare NHS Trust, London, UK cHospital Clinico San Carlos, Madrid, Spain dMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK eClinica Pediatrica, University of Padova, Padova, Italy fInserm-ANRS SC10-US19, Villejuif, France gNakornping Hospital, Chiang Mai, Thailand *Present address: U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Henry M. Jackson Foundation for the Advancement, of Military Medicine, Bethesda, Maryland, USA. †Present address: Public Health England, London, USA.
authors.forename: Jintanat
authors.initials: J
authors.lastname: Ananworanich
authors.forename: Diane
authors.initials: D
authors.lastname: Melvin
authors.forename: Jose T R
authors.initials: JT
authors.lastname: Amador
authors.forename: Tristan
authors.initials: T
authors.lastname: Childs
authors.forename: Gabriela
authors.initials: G
authors.lastname: Medin
authors.forename: Valentina
authors.initials: V
authors.lastname: Boscolo
authors.forename: Alexandra
authors.initials: A
authors.lastname: Compagnucci
authors.forename: Suparat
authors.initials: S
authors.lastname: Kanjanavanit
authors.forename: Samuel
authors.initials: S
authors.lastname: Montero
authors.forename: Diana M
authors.initials: DM
authors.lastname: Gibb
mesh_terms: D000293:Adolescent; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D002648:Child; D003071:Cognition; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000473:pathology* / Q000523:psychology; D006801:Humans; D008297:Male; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents