Microbicides: where are we now and what next?

Abstract

What have we learnt from CAPRISA 004? The pharmacokinetic and pharmacodynamic studies were not completed in May 2007 when CAPRISA 004 started, leading to criticism regarding the decision to proceed and the choice of dosing schedule [8]. The coitally dependent regimen selected was complex. ‘BAT24’ required women to apply gel within 12 h before sex, to apply a second dose up to 12 h after sex, or as soon as possible after sex if they had not applied a dose before, but no more than two doses in a 24 h period. This two-dose coital strategy was based on the reduction in HIV transmission from mother to child following a single dose of nevirapine for the mother with onset of labor, and a second dose for the child following delivery. In addition, early macaque experiments dosed with oral tenofovir and challenged intravenously s uggested that the postexposure dose was important.