DOI: 10.7910/dvn/sagxat
title: A5257: Efficacy and Tolerability of 3 Nonnucleoside Reverse Transcriptase Inhibitor–Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1: A Randomized, Controlled Equivalence Trial
title: SAS transport files and associated documentation
title: A5257 Final Analysis Datasets

description: Background: Nonnucleoside reverse transcriptase inhibitor–based antiretroviral therapy is not suitable for all treatment-naive HIV-infected persons. &lt;br&gt;&lt;br&gt;Objective: To evaluate 3 nonnucleoside reverse transcriptase inhibitor–sparing initial antiretroviral regimens to show equivalence for virologic efficacy and tolerability. &lt;br&gt;&lt;br&gt;Design: A phase 3, open-label study randomized in a 1:1:1 ratio with follow-up for at least 96 weeks. (ClinicalTrials.gov: NCT00811954) &lt;br&gt;&lt;br&gt;Setting: 57 sites in the United States and Puerto Rico. Patients: Treatment-naive persons aged 18 years or older with HIV-1 RNA levels greater than 1000 copies/mL without resistance to nucleoside reverse transcriptase inhibitors or protease inhibitors. &lt;br&gt;&lt;br&gt;Intervention: Atazanavir, 300 mg/d, with ritonavir, 100 mg/d; raltegravir, 400 mg twice daily; or darunavir, 800 mg/d, with ritonavir, 100 mg/d, plus combination emtricitabine, 200 mg/d, and tenofovir disoproxil fumarate, 300 mg/d. &lt;br&gt;&lt;br&gt;Measurements: Virologic failure, defined as a confirmed HIV-1 RNA level greater than 1000 copies/mL at or after 16 weeks and before 24 weeks or greater than 200 copies/mL at or after 24 weeks, and tolerability failure, defined as discontinuation of atazanavir, raltegravir, or darunavir for toxicity. A secondary end point was a combination of virologic efficacy and tolerability.&lt;br&gt;&lt;br&gt; Results: Among 1809 participants, all pairwise comparisons of incidence of virologic failure over 96 weeks showed equivalence within a margin of equivalence defined as −10% to 10%. Raltegravir and ritonavir-boosted darunavir were equivalent for tolerability, whereas ritonavir-boosted atazanavir resulted in a 12.7% and 9.2% higher incidence of tolerability discontinuation than raltegravir and ritonavir-boosted darunavir, respectively, primarily because of hyperbilirubinemia. For combined virologic efficacy and tolerability, ritonavir-boosted darunavir was superior to ritonavir-boosted atazanavir, and raltegravir was superior to both protease inhibitors. Antiretroviral resistance at the time of virologic failure was rare but more frequent with raltegravir. Limitation: The trial was open-label, and ritonavir was not provided. &lt;br&gt;&lt;br&gt;Conclusion: Over 2 years, all 3 regimens attained high and equivalent rates of virologic control. Tolerability of regimens containing raltegravir or ritonavir-boosted darunavir was superior to that of the ritonavir-boosted atazanavir regimen.
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.