Cape Town — Health Minister Manto Tshabalala-Msimang has ordered the newly formed National Health Research Ethics Council to investigate all anti-HIV vaginal gel trials in SA.

This follows last week's shock news that an international microbicide trial involving South African women was halted after early results suggested the microbicide might raise, not lower, the risk of HIV infection.

SA is at the forefront of international research into anti-HIV microbicides as it has good research infrastructure and a large HIV- positive population of more than 5,5-million. Scientists hope microbicides will offer women a discreet way to reduce their risk of contracting HIV from an infected partner, particularly where men are reluctant to use condoms.

Last week U.S.-based health research group Conrad announced that it was halting studies of Ushercell, a gel containing a cotton-based compound called cellulose sulphate, after interim analysis of trial data from more than 1300 women in SA, Benin, Uganda and India showed the gel may do more harm than good. An independent committee found more HIV infections among women using the microbicide than those given a dummy gel.

The World Health Organisation and the United Nations Aids agency UNAIDS said at the time it was unclear why the product had failed. The South African arm of the research was headed by the Medical Research Council's (MRC's) Prof Gita Ramjee, and funded by the US Agency for International Development and the Bill and Melinda Gates Foundation. A second study of Ushercell involving 1700 women in Nigeria was also stopped as a precaution. The MRC has emphasised that 11 previous studies of the gel had not identified any problems.

Yesterday the health minister met local scientists involved in the aborted cellulose sulphate gel trial, including MRC president Anthony Mbewu, and discussed the "disturbing news" of its failure, said her spokesman Sibane Mngadi.

The MRC was involved in five of six international microbicide trials in SA.

The "ethical practice of research has become a major concern over the past few years, particularly regarding the vulnerability of research participants", she said.

Mngadi said the minister wanted assurances that the South African women recruited for the trial were provided with sufficient information and fully understood the risks.

The cellulose sulphate gel trial, based in Durban, was approved by research ethics committees at the MRC and the University of Kwa- Zulu-Natal. Mbewu welcomed the investigataion, saying: "We're confident they won't find evidence of wrong doing."

The Research Ethics Council's investigation would seek to determine if trial protocols had been correctly followed, said Mngadi. The minister had also asked the independent monitoring committee to provide as much information as possible.

Ramjee said the MRC had informed all 604 South African women involved in the cellulose sulphate trial of its problems, but was still awaiting details from the monitoring committee about how many of them became infected with HIV. Conrad would pay for treatment for women who became infected during the trial, she said.