In Vitro Preclinical Testing of Nonoxynol-9 as Potential Anti-Human Immunodeficiency Virus Microbicide: a Retrospective Analysis of Results from Five Laboratories
| Autor: | Luke A. Pallansch, Ena Bromley, Mary K. Howett, Brigitte E. Beer, Patricia A. Welsh, Robert W. Buckheit, Brian Wigdahl, Nicola Richardson-Harman, Bradley J. Catalone, Carol Lackman-Smith, Fred C. Krebs, Shendra R. Miller, Gustavo F. Doncel, Clay Osterling, Robin J. Shattock, Karen M. Watson, Jim A. Turpin, James E. Cummins, Charlene S. Dezzutti, Patricia Reichelderfer, Marie K. Mankowski, Patricia S. Fletcher |
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| Rok vydání: | 2006 |
| Předmět: |
Anti-HIV Agents
Nonoxynol Pharmacology Virus Replication Antiviral Agents Cell Line Anti-Infective Agents Microbicide Medicine Pharmacology (medical) Nonoxynol-9 Retrospective Studies Reproducibility business.industry Vaginal microbicide Reproducibility of Results In vitro Clinical trial Microbicides for sexually transmitted diseases Infectious Diseases Immunology Toxicity HIV-1 business medicine.drug |
| Zdroj: | Antimicrobial Agents and Chemotherapy. 50:713-723 |
| ISSN: | 1098-6596 0066-4804 |
| Popis: | The first product to be clinically evaluated as a microbicide contained the nonionic surfactant nonoxynol-9 (nonylphenoxypolyethoxyethanol; N-9). Many laboratories have used N-9 as a control compound for microbicide assays. However, no published comparisons of the results among laboratories or attempts to establish standardized protocols for preclinical testing of microbicides have been performed. In this study, we compared results from 127 N-9 toxicity and 72 efficacy assays that were generated in five different laboratories over the last six years and were performed with 14 different cell lines or tissues. Intra-assay reproducibility was measured at two-, three-, and fivefold differences using standard deviations. Interassay reproducibility was assessed using general linear models, and interaction between variables was studied using step-wise regression. The intra-assay reproducibility within the same N-9 concentration, cell type, assay duration, and laboratory was consistent at the twofold level of standard deviations. For interassay reproducibility, cell line, duration of assay, and N-9 concentration were all significant sources of variability ( P < 0.01). Half-maximal toxicity concentrations for N-9 were similar between laboratories for assays of similar exposure durations, but these similarities decreased with lower test concentrations of N-9. Results for both long (>24 h) and short ( |
| Databáze: | OpenAIRE |
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