DOI: 10.7910/dvn/vxfxqc
title: A5241: The Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen
title: SAS transport files and associated documentation
title: A5241 Final Analysis Datasets

description: Background: Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. &lt;br&gt;&lt;br&gt;
Objective: To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. 
Design: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394). 
Setting: Outpatient HIV clinics. &lt;br&gt;&lt;br&gt;
Participants: Treatment-experienced patients with HIV infection and viral resistance. 
Intervention: Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. &lt;br&gt;&lt;br&gt;
Measurements: The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. &lt;br&gt;&lt;br&gt;
Results: 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, -6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. &lt;br&gt;&lt;br&gt;
Limitation: Unblinded study design, and the study may not be applicable to resource-poor settings. &lt;br&gt;&lt;br&gt;
Conclusion: Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population.
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.