DOI: 10.7910/dvn/bmuahb
title: A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with no Intensification or Intensification with Dolutegravir alone for the Treatment of Cognitive Impairment in HIV
title: SAS transport files and associated documentation
title: A5324 Final Analysis Datasets

description: Background: Neurocognitive impairment (NCI) in people with HIV (PWH) on antiretroviral therapy (ART) is common and may result from persistent HIV replication in the central nervous system.&lt;br&gt;&lt;br&gt;
Methods: A5324 was a randomized, double-blind, placebo-controlled, 96-week trial of ART intensification with dolutegravir (DTG) + MVC, DTG + Placebo, or Dual - Placebo in PWH with plasma HIV RNA &lt;50 copies/mL on ART and NCI. The primary outcome was the change on the normalized total z score (ie, the mean of individual NC test z scores) at week 48.&lt;br&gt;&lt;br&gt;
Results: Of 357 screened, 191 enrolled: 71% male, 51% Black race, 22% Hispanic ethnicity; mean age 52 years; mean CD4+ T-cells 681 cells/µL. Most (65%) had symptomatic HIV-associated NC disorder. Study drug was discontinued due to an adverse event in 15 (8%) and did not differ between arms (P = .17). Total z score, depressive symptoms, and daily functioning improved over time in all arms with no significant differences between them at week 48 or later. Adjusting for age, sex, race, study site, efavirenz use, or baseline z score did not alter the results. Body mass index modestly increased over 96 weeks (mean increase 0.32 kg/m2, P = .006) and did not differ between arms (P &gt; .10).&lt;br&gt;&lt;br&gt;
Conclusions: This is the largest, randomized, placebo-controlled trial of ART intensification for NCI in PWH. The findings do not support empiric ART intensification as a treatment for NCI in PWH on suppressive ART. They also do not support that DTG adversely affects cognition, mood, or weight.
description: USING THE SAS FILES: The SAS transport file (.trn) contains the datasets for this study. 
To use the unpacking program provided (unpack.sas), place the program and the SAS transport (.trn) file in the same directory, then run unpack.sas using SAS. The files will unpack into that directory.
Please note that the unpacking program must be used because of the way SAS handles transferring datasets from one computer system to another. A file named format.values.lst is provided to provide information about SAS formats.

NOTES ABOUT THE DE-IDENTIFIED FILES: The data are de-identified so that no original identifiers are included in the data files. 
In order to de-identify data for public use, all dates have been converted to the number of days from a reference date.
The SAS labels specify the start day for the calculation of the number of days in the variable. 
All site and institution information has been removed. 
Also, any other variable that has been deemed inappropriate to include in these public use datasets has been removed. 
This might limit how the files can be used. The de-identification process has been done in response to current regulatory requirements. 

RAW DATA FILES: The zip file contains comma separated value (.csv) files for this study.

ADDITIONAL INFORMATION: Additional information concerning the data can be found in the file documentation files and metadata.csv.