DOI: 10.7910/dvn/t0rofr
title: A5263: A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings
title: SAS transport files and associated documentation

description: Background: Optimal treatment regimens for AIDS-associated Kaposi sarcoma, a frequent contributor to morbidity and mortality among people with HIV, have not been systematically evaluated in low-income and middle-income countries, where the disease is most common. In this study, we aimed to investigate optimal treatment strategies for advanced stage disease in areas of high prevalence and limited resources.&lt;br&gt;&lt;br&gt;
Methods: In this open-label, non-inferiority trial, we enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) with a centralised computer system to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine). The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group. Safety was assessed in all eligible treated study participants. The study was registered with ClinicalTrials.gov, NCT01435018.&lt;br&gt;&lt;br&gt;
Findings: 334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm, as per the recommendations of the Data and Safety Monitoring Board (DSMB). The etoposide plus ART arm also closed due to inferiority in March, 2016, following a DSMB recommendation. Week-48 PFS rates were higher in the paclitaxel plus ART arm than in both investigational arms. The absolute differences in PFS were –30% (95% CI –52 to –8) for the comparison of paclitaxel plus ART (week 48 PFS 50%, 32 to 67; n=59) and etoposide plus ART (20%, 6 to 33; n=59), and –20% (–33% to –7%) for the comparison of paclitaxel plus ART (64%, 55 to 73; n=138) and bleomycin and vincristine plus ART (44%, 35 to 53; n=132). Both CIs overlapped the non-inferiority margin. The most common adverse events, in 329 eligible participants who began treatment, were neutropenia (48 [15%]), low serum albumin (33 [10%]), weight loss (29 [9%]), and anaemia (28 [9%]), occurring at similar frequency across treatment arms.&lt;br&gt;&lt;br&gt;
Interpretation: Non-inferiority of either investigational intervention was not shown, with paclitaxel plus ART showing superiority to both oral etoposide plus ART and bleomycin and vincristine plus ART, supporting its use in treating advanced AIDS-associated Kaposi sarcoma in resource-limited settings.
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.