Safety and tolerance of cidofovir as a 2% gel for local application in high-grade cervical intraepithelial neoplasia: A phase 1 investigation

Bossens, Michel; Jost, Maud; Van Pachterbeke, Catherine; De Maertelaer, Viviane; Simon, Philippe; Frankenne, Francis; Hubert, Philippe; Evrard, Brigitte; Snoeck, Robert

doi:10.5414/CP203126

Safety and tolerance of cidofovir as a 2% gel for local application in high-grade cervical intraepithelial neoplasia: A phase 1 investigation

Author:

Bossens, Michel

Jost, Maud ; Van Pachterbeke, Catherine ; De Maertelaer, Viviane ; Simon, Philippe ; Frankenne, Francis ; Hubert, Philippe ; Evrard, Brigitte ; Snoeck, Robert

Keywords:

Science & Technology, Life Sciences & Biomedicine, Pharmacology & Pharmacy, cervical intraepithelial neoplasia, cidofovir, pharmacokinetics, topical, HUMAN-PAPILLOMAVIRUS INFECTION, TOPICAL CIDOFOVIR, CLINICAL PHARMACOKINETICS, DOUBLE-BLIND, MULTICENTER, EFFICACY, TRIAL, LESIONS, HERPES, MEN, Administration, Topical, Adult, Antiviral Agents, C-Reactive Protein, Cidofovir, Cytosine, Female, Follow-Up Studies, Gels, Humans, Organophosphonates, Surveys and Questionnaires, Time Factors, Young Adult, Uterine Cervical Dysplasia, 1115 Pharmacology and Pharmaceutical Sciences, 3214 Pharmacology and pharmaceutical sciences

Abstract:

The primary objective was to evaluate the safety and local tolerance of a topical 2% (w/w) cidofovir gel, applied directly to the cervices of women with high-grade cervical intraepithelial neoplasia (CIN 2+). The secondary objective was to evaluate the pharmacokinetics of cidofovir during the treatment.