Cellegy discontinues Savvy Phase III

CLGY discontinued a Ghanaian Phase III trial of Savvy (C31G) vaginal gel to prevent HIV transmission after a data monitoring committee said the product's efficacy could not be determined because of a lower than expected rate of HIV seroconversion, the primary endpoint. After 18 months, the annual rate of HIV seroconversion was 1.2%, about one-third of the expected 3.7% annual rate. CLGY said the lower rate may have been caused in part by procedures taken to ensure ethical trial design, including counseling on HIV prevention and distributing condoms. ...