Phase II Trial With PRO 2000 to Prevent HIV Transmission Begins in Africa

Indevus Pharmaceuticals Inc. announced the initiation of a phase II clinical trial in Kampala, Uganda, to assess the safety of PRO 2000, a topically administered vaginal microbicide designed to prevent HIV infection. The randomized, double-blind, placebo-controlled trial will enroll approximately 100 sexually active female volunteers to be treated for four weeks. Researchers will evaluate the safety of PRO 2000 during and at the end of the study, based on the presence of local genital effects and systemic abnormalities.

The European Commission is funding the study, which is a collaboration among investigators at the Imperial College in London and the Medical Research Council Clinical Trials Unit in London; the MRC Program on AIDS in Uganda, Uganda Virus Research Institute, Entebbe; St. Francis' Hospital, Nsambya, Kampala, Uganda; and Indevus. Indevus has filed an investigational new drug application for PRO 2000 with U.S. Food and Drug Administration.

"This trial will provide safety data for PRO 2000 in a sexually active, developing-country population, and PRO 2000 may be investigated in such African populations in expanded phase III testing in the future," said Dr. Bobby Sandage, executive vice president, research and development at Indevus. "Findings will build upon the growing clinical database for the drug. The current database includes a previous phase I trial sponsored by the MRC in healthy, sexually abstinent women, as well as a phase I/II trial sponsored by the National Institutes of Health in healthy, sexually active women and HIV-infected, sexually abstinent women.

"The majority of HIV infections are now acquired through heterosexual intercourse," Sandage continued. "Because vaginal microbicides increase the opportunities for sexually active women to play a more active role in the prevention of heterosexual transmission of HIV, we see this as a potentially important new HIV prevention strategy."

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