DOI: 10.7910/dvn/8dzmjn
title: PROMISE 1077AP: Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries (PROMISE) – Antepartum Cohort
title: SAS transport files and associated documentation
title: Additional PROMISE Breast Feeding Cohort dataset available

description: BACKGROUND: Randomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lacking.&lt;br&gt;&lt;br&gt;
METHODS: We randomly assigned HIV-infected women at 14 or more weeks of gestation with CD4 counts of at least 350 cells per cubic millimeter to zidovudine and single-dose nevirapine plus a 1-to-2-week postpartum “tail” of tenofovir and emtricitabine (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based ART); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). The primary outcomes were HIV transmission at 1 week of age in the infant and maternal and infant safety.&lt;br&gt;&lt;br&gt;
RESULTS: The median CD4 count was 530 cells per cubic millimeter among 3490 primarily black African HIV-infected women enrolled at a median of 26 weeks of gestation (interquartile range, 21 to 30). The rate of transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8%; difference, −1.3 percentage points; repeated confidence interval, −2.1 to −0.4). However, the rate of maternal grade 2 to 4 adverse events was significantly higher with zidovudine-based ART than with zidovudine alone (21.1% vs. 17.3%, P = 0.008), and the rate of grade 2 to 4 abnormal blood chemical values was higher with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%, P = 0.03). Adverse events did not differ significantly between the ART groups (P&gt;0.99). A birth weight of less than 2500 g was more frequent with zidovudine-based ART than with zidovudine alone (23.0% vs. 12.0%, P&lt;0.001) and was more frequent with tenofovir-based ART than with zidovudine alone (16.9% vs. 8.9%, P = 0.004); preterm delivery before 37 weeks was more frequent with zidovudine-based ART than with zidovudine alone (20.5% vs. 13.1%, P&lt;0.001). Tenofovir-based ART was associated with higher rates than
zidovudine-based ART of very preterm delivery before 34 weeks (6.0% vs. 2.6%, P = 0.04) and early infant death (4.4% vs. 0.6%, P = 0.001), but there were no significant differences between tenofovir-based ART and zidovudine alone (P = 0.10 and P = 0.43). The rate of HIVfree survival was highest among infants whose mothers received zidovudine-based ART.&lt;br&gt;&lt;br&gt;
CONCLUSIONS: Antenatal ART resulted in significantly lower rates of early HIV transmission than zidovudine alone but a higher risk of adverse maternal and neonatal outcome.
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.