Project Ubuzima to continue trials of microbicide Dapirivine

Project Ubuzima, an international not-for-profit group conducting clinical trials of microbicides, last week "assured the public" it will continue its trial of the microbicide Dapirivine in Rwanda, the New Times/AllAfrica.com reports.

Because Dapirivine is another type of microbicide, last month's closure of Phase III clinical trials of the microbicide Ushercell will not affect Project Ubuzima, organizers said (Munyaneza, New Times/AllAfrica.com, 2/15).

Microbicides include a range of products -- such as gels, films and sponges -- that could help prevent the sexual transmission of HIV and other infections.

Arlington, Va.-based Conrad late last month halted trials of the Ushercell, also known as cellulose sulfate, that involved about 1,300 women in Benin, India, South Africa and Uganda because of an increased risk of HIV transmission among women who used cellulose sulfate compared with women who used a placebo gel.

A separate study of Ushercell involving 1,700 participants in Nigeria and conducted by Triangle Park, N.C.-based Family Health International also was halted in response to the findings of the Conrad study.

The FHI study had found neither an increased risk of HIV transmission nor a benefit in preventing transmission of the virus (Kaiser Daily HIV/AIDS Report, 2/1).

Project Ubuzima earlier this month in a statement said the closure of the Conrad trial is "disappointing and unexpected but does not mean that microbicide development should stop."

The statement added, "Drug development always involves many failures before one success and in this case, when we do eventually have success, this will save millions of lives."

Eveline Geubbles, scientific manager for Project Ubuzima, said she is confident that the safety trials underway for Dapirivine gel will have positive results.

Dapirivine is in the final stages of Phase I and Phase II testing, the Times/AllAfrica.com reports.

Trials of the microbicide also are being conducted in Tanzania and South Africa (New Times/AllAfrica.com, 2/15).

Following the closure of the Ushercell trials, there now are three Phase III microbicide trials underway.

The Population Council is conducting a study of Carraguard in South Africa, with results expected by the end of the year.

The U.K. Medical Research Council is conducting a study of PRO 2000 in South Africa, Tanzania and Uganda, with results expected by 2009. In addition, NIH is conducting a study of PRO 2000 used in combination with BufferGel in Malawi, South Africa, Zambia and Zimbabwe, with results expected in 2008 (Kaiser Daily HIV/AIDS Report, 2/1).