Unacceptable side-effects associated with a hyperosmolar vaginal microbicide in a phase 1 trial

C J Lacey, S Woodhall, Z Qi, S Sawant, M Cowen, S McCormack, S Jiang

Research output: Contribution to journalArticlepeer-review

Abstract

We carried out a phase 1 trial of a candidate vaginal microbicide gel against HIV-1 and other sexually transmitted diseases, which contained cellulose acetate 1,2-benzenedicarboxylate (also known as cellulose acetate phthalate) in a glycerol-based vehicle. We had to terminate the study after five women had completed dosing, due to all women experiencing unacceptable vulvo-vaginal side-effects. Further investigations showed that the gel had a very high osmolality, which we believe led to excessive fluid transudation across the vaginal mucosa and acute mucosal dysfunction. We also showed that the rheology of the gel changed dramatically on fluid dilution. The osmolality and rheology of candidate microbicides and other genital mucosal products should therefore be analysed and considered at an early stage of product development.
Original languageEnglish
Pages (from-to)714-7
Number of pages4
JournalInternational journal of STD & AIDS
Volume21
Issue number10
DOIs
Publication statusPublished - Oct 2010

Keywords

  • Administration, Intravaginal
  • Adolescent
  • Adult
  • Anti-Infective Agents
  • Cellulose
  • Female
  • Humans
  • Middle Aged
  • Osmolar Concentration
  • Sexually Transmitted Diseases
  • Vaginal Creams, Foams, and Jellies
  • Young Adult

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