Folks in the prevention community heard about this a bit ago, but it's now public knowledge. This sums up the findings:
Women participated from nine months to two years, with 4,244 completing the study. About 18 percent dropped out, often because they became pregnant and the gel is not known to be safe for use in pregnancy. Another 13 percent could not be found for follow up information.
At the end of the study, there were 134 new HIV infections in the Carraguard group and 151 in the fake gel group — a rate of 3.3 infections per 100 women each year in the microbicide group and 3.7 for the placebo group.
There are several ongoing trials still in place involving both rectal and vaginal microbicides. You can find out more about the work that Jim Pickett and others are doing in the world of rectal microbicides, on the newly redesigned website of the International Rectal Microbicide Advocates, here.
UPDATE: My friend from San Francisco, Mitchel, just posted this helpful comment:
While it is disappointing that the results of this trial were not what we hoped there are still some good outcomes here. this is the first phase 3 trial to finish its run completely, showing that a microbicide trial can be run safely, ethically and successfully. i really hope this accomplishment alone provides momentum for moving forward with new microbicide candidates.
Thanks, Mitchell, for the 411! He also passed along this helpful website, The Global Campaign for Microbicides. Check it out!
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hey trevor,
i didn't know you were so interested in microbicide development. two related posts in a couple days…i've been doing work with the global campaign for microbicides for several years and would definitely recommend you check them out www.global-campaign.org.
while it is disappointing that the results of this trial were not what we hoped there are still some good outcomes here. this is the first phase 3 trial to finish its run completely, showing that a microbicide trial can be run safely, ethically and successfully. i really hope this accomplishment alone provides momentum for moving forward with new microbicide candidates.