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The Capital Region of Denmark - a part of Copenhagen University Hospital
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No Neurocognitive Advantage for Immediate Antiretroviral Treatment in adults with greater than 500 CD4+ T Cell Counts

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  • Edwina J Wright
  • Birgit Grund
  • Kevin R Robertson
  • Lucette Cysique
  • Bruce J Brew
  • Gary L Collins
  • Mollie Poehlman-Roediger
  • Michael Vjecha
  • Augusto Penalva de Oliveira
  • Barbara Standridge
  • Cate Carey
  • Anchalee Avihingsanon
  • Eric Florence
  • Jens D Lundgren
  • Alejandro Arenas-Pinto
  • Nicolas J Mueller
  • Alan Winston
  • Moses Supercharger Nsubuga
  • Luxi Lal
  • Richard W Price
  • INSIGHT START Neurology Substudy Group
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OBJECTIVE: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with >500 CD4+ cells/μL.

DESIGN: Randomized trial.

METHODS: The START parent study randomized participants to commence immediate versus deferred ART until CD4+ <350 cells/μL. The START Neurology substudy used 8 neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models.

RESULTS: 592 participants had a median age of 34 years; median baseline CD4+ count of 629 cells/μL; the mean follow-up was 3.4 years. ART was used for 94% and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI: -0.062 to 0.027, p = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (p < 0.001 for increase from baseline).

CONCLUSIONS: We observed substantial improvement in neurocognitive test performance during the first year in both study arms, underlining the importance of using a control group in studies assessing neurocognitive performance over time. Immediate ART neither benefitted nor harmed neurocognitive performance in individuals with CD4+ cell counts above 500 cells/μL.

Original languageEnglish
JournalAIDS (London, England)
Volume32
Issue number8
Pages (from-to)985-997
ISSN0269-9370
DOIs
Publication statusPublished - May 2018

    Research areas

  • Journal Article

ID: 52717484