However, he said his team had learnt valuable lessons in setting up trials, managing data, building confidence among participants, and adhering to good clinical practices.
For Dr Suniti Solomon, Director of YRG Care, Chennai, too the halt is a “huge disappointment.” YRG Care had enrolled 250 women, including sex workers who were not HIV positive.
“They (Conrad) had found problems at a site in Africa last year itself and had immediately told us to stop the trial here, in October last year,” Solomon said.
Like in the Bagalkot study, none of the participants in Chennai had contracted the HIV virus, said Solomon.
Scientists are particularly surprised at the calling-off of the trial for cellulose sulphate, because it had already reached Phase-III, after clearing multiple safety trials. In 2000, another microbicide on trial, nonoxynol-9, had been declared unsafe.
Trials continue, however, on two other microbicides, Pro 2000 of Indevus Pharma, and BufferGel of ReProtect and Carreguard, whose trademark is held by the Population Council.
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