Publications & Reports

No Neurocognitive Advantage for Immediate Antiretroviral Treatment in adults with greater than 500 CD4+ T Cell Counts.

Wright EJ, Grund B, Robertson KR, Cysique L, Brew BJ, Collins GL, Poehlman-Roediger M, Vjecha M, Penalva de Oliveira A, Standridge B, Carey C, Avihingsanon A, Florence E, Lundgren JD, Arenas-Pinto A, Mueller NJ, Winston A, Nsubuga MS, Lal L, Price RW; INSIGHT START Neurology Substudy Group
Department of Infectious Diseases Alfred Health, Monash University, Burnet Institute, The Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.


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/muL. DESIGN: Randomized trial. METHODS: The START parent study randomized participants to commence immediate versus deferred ART until CD4+ <350 cells/muL. 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/muL; 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/muL.

Link to publisher’s web site


  • Journal: AIDS
  • Published: 08/02/2018
  • Volume: 32
  • Issue: 8
  • Pagination: 985-997