U.K. Microbicides Development Programme Begins Enrollment of Phase III Trial in Africa
The U.K. Microbicides Development Programme will begin enrolling women in Uganda and South Africa in a Phase III clinical trial of Lexington, Mass.-based Indevus Pharmaceuticals' experimental microbicide PRO 2000, Indevus announced on Tuesday, BBC News reports (BBC News 10/24). PRO 2000 can be applied before sexual intercourse and is formulated to prevent HIV from attaching to human cells. The 39-month trial will be conducted by MDP -- a $74 million partnership between the U.K. Department for International Development and the U.K. Medical Research Council -- and administered by the MRC Clinical Trials Unit and Imperial College London. Researchers plan to enroll more than 10,000 women in South Africa, Tanzania, Uganda and Zambia (Kaiser Daily HIV/AIDS Report, 4/7). Participants in the trial will randomly be given either a placebo or one of two strengths of PRO 2000 (Press Association/Scotsman, 10/25). The women will be asked to apply the product before sexual intercourse, and each participant also will be given condoms and HIV prevention counseling. The program has opened enrollment for the trial at clinics in Johannesburg, South Africa, and the Masaka district in Uganda and plans to open additional sites in South Africa, Tanzania and Zambia (Indevus release, 10/25).
Julie Bakobaki, MRC clinical trials manager, said, "Early safety studies of this particular microbicide have been extremely encouraging," adding, "It's very exciting after four years of preparatory work to reach the point of enrollment into this trial. Showing this microbicide protects against HIV would represent a tremendous breakthrough in the fight against the spread of HIV/AIDS" (AFP/News24.com, 10/25). Indevus CEO Glen Cooper said PRO 2000 also is being tested in an NIH-sponsored trial at sites in the U.S. and Africa, adding, "We believe, upon successful completion of the trials, we would be in a position to file marketing applications with regulatory authorities, including a new drug application with [FDA]" (Indevus release, 10/25).