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Current Trials
Microbicide clinical trials are taking place in many different parts of the world. Unlike typical drug trials, most microbicide trials are not sponsored by the pharmaceutical industry, but are designed and paid for by government and non-profit entities.
Visit our 'Download Materials' and check out factsheets #13 and #14 for information on on-going clinical trials US English - English - Spanish - French - Russian
The Alliance for Microbicide Development maintains a detailed database of ongoing clinical trials of microbicides. You can access this database by visiting their website: www.microbicide.org.
Most effectiveness trials for vaginal microbicides will have to be conducted primarily in developing countries.
Safety testing of new vaginal products (Phases 1 and 2) can take place almost anywhere. The only requirement is that the investigator be able to enrol and follow women and/or couples who are healthy and at little or no risk of sexually transmitted infections.
Phase 3 effectiveness trials, however, must take place among women at substantial risk of HIV who are not injecting drugs. In order to establish whether an experimental product works, women must be exposed to HIV only through vaginal intercourse (otherwise investigators would not be able to tell whether an infection that occurs in the experimental group is because the microbicide failed or because the woman became infected through injecting drug use).
Phase 3 efficacy trials will likely involve multiple sites in both the industrial and developing world. The number of women required to mount a Phase 3 trial is usually between 4.000 - 10.000. This is a function of many factors, including the underlying rate of HIV transmission in the population and the effect size to be detected (i.e., it takes a bigger trial to detect a microbicide that is only 50-percent effective than one that is 70-percent effective.)
For a trial to be feasible, the underlying rate of HIV infection in the population must exceed 2 percent a year. The number of trial participants required to detect a microbicide of 50-percent efficacy in a population with an underlying rate of infection of 3 percent a year is 4,847; this jumps to 14,736 participants when the infection rate is 1 percent a year.
Most of the sites with high infection rates are in the developing world. The current epidemiology of the epidemic means that it would be scientifically impossible to mount a phase 3 effectiveness trial exclusively in the industrial world.
