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HIV prevention trial in women is abandoned after drugs show no impact on infection rates

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d2613 (Published 20 April 2011) Cite this as: BMJ 2011;342:d2613
  1. Bob Roehr
  1. 1Washington, DC

A trial to determine whether treating African women prophylactically with a drug used to treat HIV can prevent them becoming infected with the virus has been stopped early after an independent data monitoring committee said it was “highly unlikely” that the study would demonstrate effectiveness.

The FEM-PrEP study was being conducted at four sites in Kenya, South Africa, and Tanzania. It used orally available placebo or Truvada, a mainstay of HIV treatment in the US and Europe. Truvada is a single pill that combines the drugs emtricitabine and tenofovir disoproxil fumarate.

The monitoring committee conducted a planned interim analysis on 18 February after the trial accrued 56 infections or 75% of the planned 72 infection end points. On the basis of that analysis it recommended on 14 April that the trial …

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