Phase III Trials of Microbicide Carraguard Underway, Expected To Be Completed by March 2007
Phase III clinical trials of the experimental microbicide Carraguard are underway in three locations in South Africa and are expected to be completed by March 2007, the Wall Street Journal reports (Fleetwood, Wall Street Journal, 12/13). Microbicides include a range of products -- such as gels, films and sponges -- that could help prevent the sexual transmission of HIV and other infections (Kaiser Daily HIV/AIDS Report, 10/11). Carraguard -- which is being developed by the New York City-based not-for-profit Population Council -- is one of more than 60 microbicides in various stages of development and clinical trials, according to the Journal. Most versions of microbicides are being developed by not-for-profit organizations and small companies. Pharmaceutical manufacturers, including Bristol-Myers Squibb, Johnson & Johnson and Merck are providing compounds for research. Carraguard in Phase III trials is being tested for use one hour before intercourse and has not shown any significant side effects in Phase I and II tests involving animals and humans. Population Council said it plans to seek its first regulatory approval from the South African Medicines Control Council and then from FDA if the Phase III trials data is valid and if Carraguard is effective at preventing HIV transmission, the Journal reports. "Our goal is to develop a product used by women in the countries hardest hit by HIV, and so we will work with regulatory entities in those countries," Melissa May, director of public information for Population Council, said. According to Zeda Rosenberg, chief executive of the Silver Spring, Md.-based not-for-profit International Partnership for Microbicides, microbicide candidates also will be tested for use during a 24-hour window and possibly even on a monthly basis. First-generation microbicides are expected to have an HIV prevention efficacy range from 40% to 70%, with the lowest rate preventing 18% of HIV infections, the Journal reports. At 60% HIV prevention effectiveness, 35% of new HIV infections could be averted, according to the Journal (Wall Street Journal, 12/13).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.