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Randomized Controlled Trial
. 2016 Jul 15;63(2):257-64.
doi: 10.1093/cid/ciw279. Epub 2016 May 3.

Neurocognitive Function and Neuroimaging Markers in Virologically Suppressed HIV-positive Patients Randomized to Ritonavir-boosted Protease Inhibitor Monotherapy or Standard Combination ART: A Cross-sectional Substudy From the PIVOT Trial

Alejandro Arenas-Pinto  1 , Wolfgang Stöhr  2 , Hans Rolf Jäger  3 , Lewis Haddow  4 , Amanda Clarke  5 , Margaret Johnson  6 , Fabian Chen  7 , Alan Winston  8 , Claudia Godi  3 , Steffi Thust  3 , Rita Trombin  4 , Janet Cairns  2 , Bhavana S Solanky  9 , Xavier Golay  3 , Nicholas I Paton  10 ; PIVOT Neurocognitive sub-study Team
Collaborators, Affiliations
Randomized Controlled Trial

Neurocognitive Function and Neuroimaging Markers in Virologically Suppressed HIV-positive Patients Randomized to Ritonavir-boosted Protease Inhibitor Monotherapy or Standard Combination ART: A Cross-sectional Substudy From the PIVOT Trial

Alejandro Arenas-Pinto et al. Clin Infect Dis. .

Abstract

Background: To determine whether treatment with ritonavir-boosted protease inhibitor (PI) monotherapy is associated with detrimental effects on neurocognitive function or brain imaging markers compared to standard antiretroviral therapy (ART).

Methods: Neuropsychological assessment and brain magnetic resonance imaging were performed at the last study visit in a subset of participants randomized to PI monotherapy (PI-mono group) or ongoing triple ART (OT group) in the PIVOT trial. We calculated a global z-score (NPZ-7) from the average of the individual test z-scores and the proportion of participants with symptomatic neurocognitive impairment (score >1 standard deviation below normative means in ≥2 cognitive domains and neurocognitive symptoms). In a subgroup, white matter hyperintensities, bicaudate index, global cortical (GCA) and medial temporal lobe atrophy scores and single voxel (basal ganglia) N-acetylaspartate (NAA)/Choline, NAA/Creatine and myo-inositol/Creatine ratios were measured.

Results: 146 participants (75 PI-mono) had neurocognitive testing (median time after randomization 3.8 years), of whom 78 were imaged. We found no difference between arms in NPZ-7 score (median -0.4 (interquartile range [IQR] = -0.7; 0.1) vs -0.3 (IQR = -0.7; 0.3) for the PI-mono and OT groups respectively, P = .28), the proportion with symptomatic neurocognitive impairment (13% and 18% in the PI-mono and OT groups respectively; P = .41), or any of the neuroimaging variables (P > .05). Symptomatic neurocognitive impairment was associated with higher GCA score (OR = 6.2 per additional score; 95% confidence interval, 1.7-22.3 P = .005) but no other imaging variables.

Conclusions: Based on a comprehensive neuropsychological assessment and brain imaging, PI monotherapy does not increase the risk of neurocognitive impairment in stable human immunodeficiency virus-positive patients.

Keywords: HIV; monotherapy; neurocognitive function; neuroimaging; protease inhibitor.

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Figures

Figure 1.
Figure 1.
Participant distribution. Abbreviations: MRI/MRS, magnetic resonance imaging/spectroscopy.
See this image and copyright information in PMC

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