Analytical Advances in the Ex Vivo Challenge Efficacy Assay.

ABSTRACT: The ex vivo challenge assay is being increasingly used as an efficacy endpoint during early human clinical trials of HIV prevention treatments. There is no standard methodology for the ex vivo challenge assay, although the use of different data collection methods and analytical parameters may impact results and reduce the comparability of findings between trials. In this analysis, we describe the impact of data imputation methods, kit type, testing schedule and tissue type on variability, statistical power, and ex vivo HIV growth kinetics. Data were p24 antigen (pg/ml) measurements collected from clinical trials of candidate microbicides where rectal (n = 502), cervical (n = 88), and vaginal (n = 110) tissues were challenged with HIV-1_BaL ex vivo. Imputation of missing data usin

SUBMITTER: Richardson-Harman N 

PROVIDER: S-EPMC5372762 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature