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Related Experiment Videos

Microbicides--evaluating multiple formulations of C31G.

R Bax1, K Douville, D McCormick

  • 1Biosyn, Inc, 1800 Byberry Road, Building 13, Huntingdon Valley, PA 19006, USA. rbax@biosyn-inc.com

Contraception
|November 22, 2002
PubMed
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A new microbicide gel, 1.0% C31G, shows promise for preventing sexually transmitted diseases (STDs) and HIV. This 3-day trial found it to be the safest and most acceptable formulation tested.

Area of Science:

  • Microbiology
  • Infectious Diseases
  • Drug Development

Background:

  • A critical need exists for effective microbicides to combat the global spread of sexually transmitted diseases (STDs), including HIV.
  • Currently, no approved microbicides are available to prevent STD and HIV transmission.

Purpose of the Study:

  • To evaluate the safety and acceptability of various microbicide formulations, including C31G, in a short-term clinical trial.
  • To compare the tolerability and acceptance of different gel formulations for potential microbicide use.

Main Methods:

  • A 3-day, once-daily dosing clinical trial was conducted to assess multiple microbicide formulations.
  • A scoring algorithm, based on subject-reported symptoms and observed signs, was used to evaluate safety and acceptance.

Related Experiment Videos

  • Formulation differences were analyzed for their impact on microbicide tolerance and acceptability.
  • Main Results:

    • Significant differences in tolerance and acceptability were observed among the tested formulations.
    • The 1.0% C31G co-polymer gel demonstrated superior tolerability and acceptability compared to other formulations.
    • Results were consistent with a previous 7-day trial involving two of the formulations (1.2% HEC gel, 2.0% N-9).

    Conclusions:

    • Formulation characteristics significantly influence the tolerance and acceptability of microbicides.
    • The 1.0% C31G co-polymer gel is the most promising candidate for further development in longer trials.
    • The 3-day trial design is validated as an effective method for assessing microbicide formulations.