Clinical research with topical microbicides as a potential HIV prevention method.
An overview of the different phases in microbicide research is given with special attention to nonoxynol-9, the only ingredient that has been tested in phase III trials so far. The methodological and ethical challenges in conducting phase III studies are described. These include study population, compliance data, standardization, therapy for HIV-positive women, and informed consent. Despite these challenges, phase III trials are feasible and should be initiated now.
Van Damme
L
L
HIV/STD Research and Intervention Unit, Institute of Tropical Medicine, Antwerp, Belgium.
D017326:Clinical Trials, Phase III as Topic; D003127:Colposcopy; D019111:Single-Use Internal Condom; D004992:Ethics, Medical; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D017137:Nonoxynol / Q000494:pharmacology*; D013089:Spermatocidal Agents / Q000494:pharmacology*
D013089:Spermatocidal Agents; D017137:Nonoxynol