DOI: 10.7910/dvn/mrrbsr
title: A5288: Management Using the Latest Technologies in Resource-Limited Settings to Optimize Combination Therapy after Viral Failure - Lancet Digital Health 2019 publication
title: SAS transport files and associated documentation
title: Dataset for alternate publication in Lancet HIV 2019

description: Background: Antiretroviral therapy (ART) management is challenging for individuals in resource-limited settings presenting for third-line treatment because of complex resistance patterns, partly due to reduced access to viral load monitoring. We aimed to evaluate use of newer antiretroviral drugs and contemporary management approaches, including population-based sequencing, to select appropriate antiretrovirals, plasma viral load monitoring, and interventions to improve adherence in individuals presenting with second-line viral failure. &lt;br&gt;&lt;br&gt;
Methods: A5288 was a phase 4, third-line ART strategy study done at 19 urban sites in ten countries that enrolled adult participants with confirmed plasma HIV-1 RNA (viral load) of 1000 copies per mL or more after more than 24 weeks of protease inhibitor-based second-line ART. The primary objective was to use antiretrovirals (raltegravir, etravirine, and ritonavir-boosted darunavir) and diagnostic monitoring technologies, including viral load, genotyping, and adherence support to achieve viral load suppression (defined as ≤200 copies per mL) in 65% or more of participants. ART history and real-time drug resistance genotypes were used to assign participants to one of four cohorts: cohort A (no lopinavir resistance) stayed on second-line ART and cohorts B (B1, best available nucleoside reverse transcriptase inhibitors [NRTIs] plus ritonavir-boosted darunavir plus raltegravir; B2, ritonavir-boosted darunavir plus raltegravir plus etravirine; B3, ritonavir-boosted darunavir, raltegravir, and either tenofovir plus emtricitabine or tenofovir plus lamivudine), C (ritonavir-boosted darunavir plus raltegravir plus tenofovir-emtricitabine or tenofovir plus lamivudine), and D (best available NRTIs plus ritonavir-boosted darunavir plus raltegravir) were defined by increasing levels of resistance and received appropriate regimens, including new antiretrovirals. Participants in Cohort B without detectable hepatitis B surface antigen were assigned by blocked randomisation to cohorts B1 and B2, and those with detectable hepatitis B surface antigen were assigned to cohort B3. The trial is registered with ClinicalTrials.gov, number NCT01641367. &lt;br&gt;&lt;br&gt;
Findings: From Jan 10, 2013, to Sept 10, 2015, 545 participants were enrolled. 287 (53%) were assigned to cohort A, 74 (14%) to B1, 72 (13%) to B2, eight (1%) to B3, 70 (13%) to C, and 34 (6%) to D. Overall, 349 (64%, 95% CI 60-68) participants achieved viral suppression at week 48, with proportions varying from 125 (44%) of 287 in cohort A to 65 (88%) of 74 in cohort B1, 63 (88%) of 72 in B2, eight (100%) of eight in B3, 63 (90%) of 70 in C, and 25 (74%) of 34 in D. Participants in cohort A remained on their second-line protease inhibitor, and had the most participants with grade 3 or higher adverse events (147 [51%]). &lt;br&gt;&lt;br&gt;
Interpretation: Targeted real-time genotyping to select third-line ART can appropriately allocate more costly antiretrovirals to those with greater levels of HIV drug resistance.
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.