icon star paper   Articles  
Back grey_arrow_rt.gif
HIV Topical Microbicide Early Trials Should Have Condom Only Third Arm, Cmte. Members Say
  Source: FDAAdvisoryCommittee.com
Early trials of topical microbicides for HIV prevention should have a condom only/no treatment arm in addition to a vehicle control arm, members of FDAs Antiviral Drugs Advisory Committee said Aug. 20.
The committee was asked by FDA whether trials for HIV topical microbicides should include a third arm of condom only use in addition to the active drug and placebo vehicle control. FDA said such an arm would indicate whether the placebo vehicle control itself had any effect on HIV transmission.
Several committee members agreed that the third arm could be required for early studies of microbicides, but added that, once the question had been sufficiently answered, studies of future microbicides could follow a two-arm model.
Other committee members asserted that requiring a condom only group would be confusing and costly, and recommended that FDA require no more than a two-arm study.
Those committee members who favored the three-arm study, said that the test microbicide agent should show definitive efficacy over the placebo control and at least a trend in benefit over the condom only group. FDA is considering requiring a statistically significant benefit over both arms.
The committee also seemed to agree with FDA that a single large Phase III study could be conducted for the approval of HIV topical microbicides, instead of the standard two trials, as long as the study is adequately powered and achieves statistical significance.
Committee members split on whether there should be a Phase II run-in for the Phase III trial or a separate Phase II trial. Several members noted that a run-in to Phase III would allow for longer follow-up of subjects. Topical microbicide trials should follow subjects for at least 12 months, committee members said.
  icon paper stack View Older Articles   Back to Top   www.natap.org