Thinking about vaginal microbicide testing.

Abstract

A vaginal microbicide could slow the spread of HIV. To date, volunteers in placebo-controlled trials of candidate microbicides have been counseled to use condoms. This does not reduce the number of volunteers exposed to possible risk, but it shifts the allotment of risk from those conducting the trial to those women who may be least able to make autonomous decisions. Alternative ways of meeting the obligation to offer volunteers active benefits are explored. Counseling the use of condoms prolongs clinical trials and could cause tens of thousands of otherwise avoidable deaths.