- © 2007 Canadian Medical Association or its licensors
South Africa has launched an inquiry into ethical breaches that may have occured during a Phase III clinical trial of Canadian-made “Anti-AIDS” gel that was halted last January after preliminary results indicated use of cellulose sulfate could lead to increased risk of HIV infection.
The American reproductive health group CONRAD announced Jan. 31 that it had halted trials on Ushercell, a gel made by Canada-based Polydex Pharmaceuticals, that were being conducted on more than 1300 women in South Africa, Benin, Uganda and India. A similar trial being conducted by Family Health International in Nigeria was also halted. But another trial is just starting in Uganda.
The topical microbicidal gel is supposed to release an active ingredient that would kill HIV during sexual intercourse. Polydex said in a statement that “at this point, it is not clear why use of cellulose sulfate was associated with an increased risk of HIV infection in the CONRAD trial. The Independent Data Monitoring Committee, an independent advisory group of experts overseeing the trial, will conduct a detailed review of the data to better understand the findings, and help determine any implications for other microbicide studies.”
South African health minister Manto Tshabalala-Msimang directed the country's National Health Research Ethics Council to conduct a thorough investigation into the matter. Some 600 South African women were involved in the trials and there were media reports that some shared their gel with friends who were not part of the study.
The South Africa probe is seeking to establish whether the trials followed all ethical protocols and whether the women were given sufficient information to make informed decisions on their participation.
Several leading HIV/AIDS researchers in Africa argue that such trials need to continue if women are to find an additional tool (besides the condom) to help protect them from infection. They say HIV prevention mainly relies on the condom, but that only empowers men. “African women remain vulnerable as their poor sex negotiation skills, and low socio-economic power, mean it is the often the man who decides whether to use the condom,” Mugyenyi told CMAJ.
Women are now being enrolled for the Uganda trial, which will eventually be expanded to South Africa, Tanzania and Zambia. Dr. Anatoli Kamali, a researcher at the Medical Research Council in Uganda, says investigation of the gel called PRO2000 will proceed “because there has not been a method that women can use to protect themselves without negotiating with men.” It is hoped 710 Ugandan women will be enrolled by next March, and that preliminary results will be available by the end of 2008.
Kamali added that separate trials on 2 other gels are ongoing elsewhere in Africa, including one in Rwanda where Dr. Eveline Geubbles, scientific manager at Projet Ubuzima, told The New Times their trials on the Dapirivine gel would not be affected by the CONRAD findings. "Currently, we are at the stage of data analysis. We sent the data [to the US] for laboratory tests and we expect results around the end of this year," she said.