Starpharma reports positive results from VivaGel study

Based on these results and existing supporting data, the product is deemed suitable for continued development as a topical microbicide for the prevention of HIV and genital herpes (HSV) and the exploration of other potential indications. These findings support current and future clinical studies to assess the safety and efficacy of VivaGel for genital herpes and HIV in sexually active women. The study enrolled 54 women in the US and Kenya and was double blinded so that the participants, the investigators and study staff did not know who was receiving VivaGel or placebo gel.

Blood tests (systemic laboratory parameters) showed no evidence of any treatment-related effects in study participants. This finding was not surprising, given that consistent with previous clinical and non-clinical studies, there was no evidence of absorption of the active ingredient of VivaGel, SPL7013, into the blood after vaginal application in this study. Study participants also showed no evidence of any treatment-related effects on vaginal microflora. No participant discontinued or was required to discontinue product use due to any adverse events during the trial.

An additional positive outcome was there was no statistical difference between the VivaGel and placebo arms in the number of participants who experienced any sign or symptom including genitourinary (genital and urinary) signs or symptoms deemed to be associated with product use.