RECOMMENDATIONS FOR THE DEVELOPMENT OF VAGINAL MICROBICIDES

Vaginal microbicides are products for vaginal administration that can be used to prevent HIV infection and other sexually transmitted diseas es (STD). We recognize two potential sources of vaginal microbicides: existing spermicides and new products (new products may or may not be spermicidal). This document is meant to serve as a general guide for d evelopment and evaluation of existing and new products. For new produc ts preclinical studies will be required. Depending upon indication, in vitro activity against HIV, target STD, and sperm should also be asse ssed. Compatibility with barrier method materials should also be evalu ated. The physical-chemical properties of the active agent and the cli nical formulation should be assessed. Animals studies should be conduc ted to assess its safety and predict dosing; use of various models to assess local toxicity is indicated and microbicidal activity of the pr oduct may be evaluated if appropriate models are available. Carcinogen icity testing and segment III reproduction studies (perinatal and post -natal studies in rats) may be performed concurrently with Phase III c linical trials. All vaginal microbicides, including existing spermicid es and new products, should be clinically evaluated for safety and eff icacy. Safety studies are necessary because irritation of vaginal and cervical mucosae has been recently associated with spermicide use and those lesions might increase HIV transmission. Efficacy studies to ass ess prevention of HIV infection and/or STD, depending upon the product indication, should then be conducted with products that have been eva luated for safety and appear to be non-toxic to tissue. For spermicida l microbicides contraceptive efficacy studies will be needed.