Microbicides
Evaluating the safety of vaginal microbicides: the fundamentals
The path to vaginal microbicide availability: evaluating the safety of these HIV prevention products
Authors:
; Global Campaign for Microbicides; Global Campaign for Microbicides
Publisher:
Global Campaign for Microbicides, 2007
This information bulletin from the Global Campaign for Microbicides explains how scientists will test the safety of vaginal microbicides. When they become available these products will empower women to protect themselves from HIV infection, but they must first pass a series of scientific trials. These trials take place in a number of stages, beginning with pre-trial tests which are conducted in laboratories and on animals. There are then three phases of clinical trials in which women volunteers will participate. If safety problems arise at any phase the product does not go on to the next stage of the process.
Scientists will be looking for answers to a number of questions when conducting safety trials on vaginal microbicides. They will want to know if these products cause any harm to the vaginal lining or change the natural vaginal environment. It is particularly important to discover if these products do anything to facilitate the transmission of HIV or other sexually transmitted infections (STIs). The safety trials will also investigate if microbicides are absorbed into the bloodstream and if they have any negative effects on any other body functions. One of the key questions will be about the safety of using these products during pregnancy.
