Journal article
Natural history of progression of HPV infection to cervical lesion or clearance: Analysis of the control arm of the large, randomised PATRICIA study
U Jaisamrarn, X Castellsagué, SM Garland, P Naud, J Palmroth, MR Del Rosario-Raymundo, CM Wheeler, J Salmerón, SN Chow, D Apter, JC Teixeira, SR Skinner, J Hedrick, A Szarewski, B Romanowski, FY Aoki, TF Schwarz, WAJ Poppe, FX Bosch, NS De Carvalho Show all
Plos One | PUBLIC LIBRARY SCIENCE | Published : 2013
Abstract
Background: The control arm of PATRICIA (PApillomaTRIal against Cancer In young Adults, NCT00122681) was used to investigate the risk of progression from cervical HPV infection to cervical intraepithelial neoplasia (CIN) or clearance of infection, and associated determinants. Methods and Findings: Women aged 15-25 years were enrolled. A 6-month persistent HPV infection (6MPI) was defined as detection of the same HPV type at two consecutive evaluations over 6 months and clearance as ≥2 type-specific HPV negative samples taken at two consecutive intervals of approximately 6 months following a positive sample. The primary endpoint was CIN grade 2 or greater (CIN2+) associated with the same HPV ..
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Funding Acknowledgements
The study (NCT00122681) was funded by GlaxoSmithKline Biologicals SA, who designed the trial in collaboration with investigators. The costs related to the collection of data from this study, together with the development of this manuscript, were funded and coordinated by GlaxoSmithKline Biologicals SA. All authors contributed to the development of the manuscript and approved the manuscript for publication. The corresponding author (UJ) and the core writing team (UJ, XC, SMG, MRDRR, PN, JP (Johanna Palmroth), LB, DR) had the final responsibility for the decision to submit for publication. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.