PARIS - A VAGINAL gel failed to protect women against the Aids virus, doctors said on Monday, reporting on a major clinical trial that enrolled more than 9,000 women.
The formula, known as PRO 2000, was tested in a Phase III trial, the widest and most exhaustive stage of the process to assess a new drug for safety and effectiveness.
Aids campaigners have staked huge faith in the search for a vaginally-used gel to thwart the human immunodeficiency virus (HIV). It would revolutionise the fight on Aids by empowering women, especially in African countries where coercive sex is a problem.
The first breakthrough in this quest was announced in July at the 18th International Aids Conference in Vienna. Scientists reported that a cream tested in a Phase IIb trial in South Africa called Caprisa 004 cut the risk of HIV infection by 39 per cent overall, and by 54 per cent among those women who used it most consistently.
This level of protection may not be enough to make the Caprisa gel get approval, however. The cream incorporates tenofovir, a drug commonly used in tablet form to quell HIV by disrupting its reproduction in immune cells.
The PRO 2000 formula is different, being a so-called large charged polymer, which is intended to disrupt HIV's interaction with targeted cells. It was tested at two levels of concentration, of two per cent and 0.5 per cent, in 13 clinics in South Africa, Tanzania, Uganda and Zambia in a trial that was closely monitored for ethical standards. -- AFP