DOI: 10.7910/dvn/y6iu5w
title: P1060: NNRTI-Based vs. PI-Based ART in Infants Exposed/Not Exposed to NVP for PMTCT - New England Journal of Medicine 2010 publication
title: SAS transport files and associated documentation
title: Dataset for alternate publication in New England Journal 2012

description: Background: Single-dose nevirapine is the cornerstone of the regimen for prevention of mother-to-child transmission of human immunodeficiency virus (HIV) in resource-limited settings, but nevirapine frequently selects for resistant virus in mothers and children who become infected despite prophylaxis. The optimal antiretroviral treatment strategy for children who have had prior exposure to single-dose nevirapine is unknown. &lt;br&gt;&lt;br&gt;
Methods: We conducted a randomized trial of initial therapy with zidovudine and lamivudine plus either nevirapine or ritonavir-boosted lopinavir in HIV-infected children 6 to 36 months of age, in six African countries, who qualified for treatment according to World Health Organization (WHO) criteria. Results are reported for the cohort that included children exposed to single-dose nevirapine prophylaxis. The primary end point was virologic failure or discontinuation of treatment by study week 24. Enrollment in this cohort was terminated early on the recommendation of the data and safety monitoring board. &lt;br&gt;&lt;br&gt;
Results: A total of 164 children were enrolled. The median percentage of CD4+ lymphocytes was 19%; a total of 56% of the children had WHO stage 3 or 4 disease. More children in the nevirapine group than in the ritonavir-boosted lopinavir group reached a primary end point (39.6% vs. 21.7%; weighted difference, 18.6 percentage-points; 95% confidence interval, 3.7 to 33.6; nominal P=0.02). Baseline resistance to nevirapine was detected in 18 of 148 children (12%) and was predictive of treatment failure. No significant between-group differences were seen in the rate of adverse events. &lt;br&gt;&lt;br&gt;
Conclusions: Among children with prior exposure to single-dose nevirapine for perinatal prevention of HIV transmission, antiretroviral treatment consisting of zidovudine and lamivudine plus ritonavir-boosted lopinavir resulted in better outcomes than did treatment with zidovudine and lamivudine plus nevirapine. Since nevirapine is used for both treatment and perinatal prevention of HIV infection in resource-limited settings, alternative strategies for the prevention of HIV transmission from mother to child, as well as for the treatment of HIV infection, are urgently required.
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. 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 and SAS formats have been removed. 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 file named rawdata.zip 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.