PRO 2000 is Indevus’ microbicide under development to prevent sexually acquired HIV infection and certain other sexually transmitted disease-causing viruses and bacteria. The phase III trial is designed to test the safety and effectiveness of PRO 2000 for preventing HIV infection and other sexually transmitted infections in women.
It is expected to begin within four months in four African countries: Uganda, South Africa, Tanzania and Zambia, and to run for 39 months. An estimated 12,000 women will be enrolled.
The trial will be conducted by the Microbicides Development Programme, an international partnership funded by the UK Department for International Development (DFID) and the Medical Research Council (MRC), and coordinated by the MRC Clinical Trials Unit and the Clinical Trials Centre of Imperial College London.
A US National Institutes of Health (NIH)-sponsored clinical trial to assess the safety and preliminary effectiveness of PRO 2000 and another candidate microbicide for preventing HIV infection is currently underway in Africa and the US.