US-based reproductive health research organisation CONRAD today said its decision to call off human trial on microbicide cellolose sulphate was not a setback in HIV prevention studies among women but the failure during trials came as a “shock and surprise”.
“We are absolutely shocked and totally surprised by the preliminary results indicating that a topical microbicide gel being tested for HIV prevention in women could lead to an increased risk of HIV infection in women who use the compound,” CONRAD’s executive director, Dr Henry Gabelnick said here.
Prematurely halting the human trial of CS, which proved to be an effective contraceptive and shown very safe in 11 studies, on January 31 was “not a debacle nor a setback, but that is the way science works”, he told PTI.
“I think we have worked hard for the safety of women undergoing trial. Therefore, as soon as we detected the high risk using the microbicide at certain quarters, immediately we said stop,” Gabelnick, who is here to attend a five-day international conference, said.
“We will wait for the report of the Independent Data Monitoring Committee (IDMC), an independent advisory group of experts overseeing the trial, who will conduct a detailed review of the data to better understand the findings,” he added.
Microbicides are products being developed to be used by women to reduce the transmission of HIV during sexual intercourse. A microbicide could take the form of a gel, creamy film, tablet or sponge, or be contained in a vaginal ring that releases the active ingredient gradually. PTI