Microbicides--evaluating multiple formulations of C31G.
Despite a significant worldwide need for effective microbicides to reduce sexually transmitted diseases (STD) and HIV transmission, none is currently available. C31G, a surface active anti-infective agent that is active in vitro against bacterial and viral STD pathogens, was evaluated in a 3-day, once-daily dosing clinical trial designed to assess multiple formulations for safety and acceptance. The trial used a scoring algorithm that was based on relevant subject reported symptoms and signs observed at follow-up. Differences in tolerance and acceptability between the formulations were demonstrated, as was consistency with the results from a previous 7-day trial that involved two of the formulations (1.2% HEC gel, 2.0% N-9). The 1.0% C31G co-polymer gel was the best tolerated, most acceptable formulation, and will be advanced to longer, more comprehensive trials. Thus, formulation differences are relevant to microbicide tolerance and acceptability, and the 3-day trial design validated in this study can be used to assess formulations.
Bax
R
R
Biosyn, Inc, 1800 Byberry Road, Building 13, Huntingdon Valley, PA 19006, USA. rbax@biosyn-inc.com
Douville
K
K
McCormick
D
D
Rosenberg
M
M
Higgins
J
J
Bowden
M
M
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D001622:Betaine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D002626:Chemistry, Pharmaceutical; D004334:Drug Administration Schedule; D004739:England; D005231:Fatty Acids, Unsaturated / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009657:North Carolina; D017060:Patient Satisfaction; D010414:Pennsylvania; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*
D000890:Anti-Infective Agents; D005231:Fatty Acids, Unsaturated; D001622:Betaine; C038360:C 31G