February 8, 2007
One day after ordering an investigation into a microbicide clinical trial in eastern KwaZulu-Natal province, South African Health Minister Manto Tshabalala-Msimang confirmed Wednesday that 22 female study participants had contracted HIV.
"We have found that about 22 women from the 604 participants at the trial site in KwaZulu-Natal were infected by the AIDS virus," ministerial spokesperson Sibani Mngadi said. "We are investigating whether these women were infected as a result of the use of the microbicide, Ushercell."
Until last week, phase III trials of the cellulose sulphate gel were also being conducted Uganda, Benin, and India; however, researchers abruptly shut them down after finding that women who used Ushercell ran a higher risk of HIV infection than those using a placebo. A similar trial involving cellulose sulphate in Nigeria was stopped as a precaution, although its data did not show any risk.
Tshabalala-Msimang said she ordered the inquiry to determine whether the study participants had been properly informed about the risks. "I have asked for a thorough investigation into this matter to establish whether the study followed all protocols approved by the Medicine Control Council," she said. "We are also investigating whether the participants were given sufficient information to make informed decisions about their participation."
Treatment Action Campaign, South Africa's top AIDS lobby group, said in a statement, "The termination of the Ushercell trials is a setback for microbicide research." "It is unlikely that a successful microbicide will be found in the next few years, and it is possible that other ongoing trials will fail. Nevertheless, science advances by learning from failures, and ethical trials of the most promising microbicides should continue because the development of a successful microbicide will likely prevent many HIV infections and save many lives."