Microbicide well tolerated, even by men

Melbourne biotech Starpharma has presented results of a clinical trial indicating that its microbicide VivaGel is well-tolerated in men and is suitable for further development for the prevention of HIV and genital herpes.

The results were presented at the 4th International AIDS Society (IAS) conference on HIV Pathogenesis, Treatment and Prevention in Sydney today.

The double-blinded trial compared 36 circumcised and uncircumcised men who applied VivaGel (24 men) or a placebo gel (12 men) topically once daily for seven days.

The study demonstrated that VivaGel was safe and well tolerated, and comparable with placebo. As seen in a previous completed clinical trial in women, there was no evidence of absorption of the active ingredient of VivaGel, SPL7013, into the blood after topical application.

Acceptability was a secondary endpoint in this study and interviews indicated that VivaGel would be acceptable to participants if shown to be protective against sexually transmitted infections, and there were few concerns around the potential impact on sexual pleasure.

The clinical study was conducted at the Melbourne Sexual Health Centre, in collaboration with the Burnet Institute and the National Centre in HIV Epidemiology and Clinical Research, and was funded by the US National Institute of Allergy and Infectious Diseases and the National Institutes of Health.

VivaGel is being developed as a topical vaginal microbicide for the prevention of HIV and genital herpes, and is currently under investigation in healthy female volunteers in two separate expanded safety clinical trials at four sites in the US and Kenya.

VivaGel also shows promise as a contraceptive agent, the company said.