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AIDS. 2018 May 15;32(8):985-997. doi: 10.1097/QAD.0000000000001778.

No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts.

Author information

1
Department of Infectious Diseases Alfred Health, Monash University, Burnet Institute, The Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
2
School of Statistics, University of Minnesota, Minneapolis, Minnesota.
3
Department of Neurology, University of North Carolina, North Carolina, USA.
4
Neurosciences Research Australia, St. Vincent's Hospital Sydney, Applied Medical Research Centre.
5
Neurosciences Program, Peter Duncan Neurosciences Unit, St Vincent's Centre for Applied Medical Research, University of New South Wales, Sydney, Australia.
6
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.
7
Institute for Clinical Research, Inc, Washington, DC, USA.
8
Instituto Emilio Ribas, Sao Paulo, Brazil.
9
Veterans Affairs Medical Center, Washington DC, USA.
10
Kirby Institute, University of New South Wales, Sydney, Australia.
11
HIV-NAT Thai Red Cross AIDS Research Centre and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
12
Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
13
CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.
14
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, London, UK.
15
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zürich, Switzerland.
16
Division of Infectious Diseases, Department of Medicine, Imperial College London, London, UK.
17
People in Need Agency (PINA), Uganda.
18
Burnet Institute, Melbourne, Australia.
19
Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Abstract

OBJECTIVE:

To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 cells/μl.

DESIGN:

Randomized trial.

METHODS:

The START parent study randomized participants to commence immediate versus deferred ART until CD4 less than 350 cells/μl. The START Neurology substudy used eight 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:

The 592 participants had a median age of 34 years; median baseline CD4 count was 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).

CONCLUSION:

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.

PMID:
29424786
PMCID:
PMC5920693
[Available on 2019-05-15]
DOI:
10.1097/QAD.0000000000001778

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