Eastern Virginia Medical School Program Receives $24M From Gates Foundation, USAID To Conduct Phase III Microbicide Trial

The Eastern Virginia Medical School in Norfolk, Va., on Tuesday announced it has received a $24 million grant from the Bill & Melinda Gates Foundation and USAID to conduct a phase III clinical trial of a vaginal microbicide to prevent HIV infection, the Virginian-Pilot reports (Hardy, Virginian-Pilot, 5/4). Microbicides include a range of products such as gels, films, sponges and other products that could help prevent the sexual transmission of HIV and other sexually transmitted diseases. HIV is transmitted primarily through heterosexual intercourse in much of Africa and Asia, but no female-controlled HIV prevention method is widely available (Kaiser Daily HIV/AIDS Report, 4/15). EVMS' CONRAD program plans to use the grant to conduct a phase III trial of the microbicide gel Ushercell, which is made by Canada-based Polydex Pharmaceuticals. The trial is expected to include 2,500 women in India, South Africa, Benin, Burkina Faso and Uganda and is scheduled to begin in June and end in the summer of 2006, according to the Virginian-Pilot (Virginian-Pilot, 5/4). CONRAD Director Henry Gabelnick said Ushercell would be administered by a single-use, pre-filled applicator. CONRAD researchers said they hope the microbicide will reduce by half HIV incidence among women participating in the trials, the Newport News Daily Press reports (Buchanan, Newport News Daily Press, 5/4). According to the United Nations, 47% of the approximately 44 million HIV-positive people in the world are women, the Virginian-Pilot reports.

CONRAD Background
Federal agencies in 1986 founded CONRAD to develop less-expensive STD prevention products for use in developing countries. Researchers from the program, which formerly was known as Contraceptive Research and Development, created the first female condom (Virginian-Pilot, 5/4). In 2000, CONRAD established the Global Microbicide Project to focus research on products that women could use to protect themselves from STDs, including HIV (Newport News Daily Press, 5/4). The Gates Foundation -- which is providing $12 million of the $24 million grant -- in 2002 awarded CONRAD $11.9 million to research the effectiveness of microbicides as contraceptives and as a method of preventing the spread of HIV and other STDs (Kaiser Daily HIV/AIDS Report, 8/29/02). CONRAD also is conducting a Phase III clinical trial of a different microbicide in Nigeria, the Daily Press reports. That trial, which began last year, is funded entirely by USAID (Newport News Daily Press, 5/3). According to a CONRAD release, an effective microbicide could be developed by the end of the decade (CONRAD release, 5/3).