Carraguard Shows Promising Results

http://hpv2010.org/main/index.php?option=com_conference&view=presentation&id=1110&conference=1&Itemid=100

Results: ...After adjusting for risk factors, Carraguard was found protective for HPV infection for women who inserted >80% of their returned applicators of test product with >30% confirmed covered sex acts. Within the latter category, Carraguard was almost 50% more efficacious than placebo. Carraguard users were 0.529 as likely to contract HR-HPV [95% CI (0.304, 0.920)] as women who used placebo (P=0.0176).

Conclusions: Carraguard was shown to be effective in protecting against vaginal transmission of HR-HPV. To our knowledge, this is the first report of successful protection against genital infection by a vaginal microbicide.

We haven't seen much lately about the carrageenan studies for use as a topical preventative for HPV. Last I'd heard, they were going to human trials and the results were supposed to be out early last year, but I haven't found anything, one way or the other, until now. This particular brand that this study was testing, was found to have failed its anti-HIV test, and I posted about it at the time that I feared they would not follow up on its anti-HPV properties.

Well, apparently someone did, and it seems to be holding up against HPV. I'm still looking out for BufferGel, which was my favorite of the brands being considered, so when I hear more, I'll let ya'll know!

What Do The Phases Mean?

I've been asked about what the "phase" means in "Phase III Clinical Study", or which phase is the human trials? So I found this nifty little graph that illustrates what a "phase" is:

And MD Anderson Cancer Center does a good job of breaking it all down for you. I think in the past I thought Phase I was the lab testing, Phase II was animal testing, and Phase III was human testing, but that's apparently not the case.

Basically, Preclinical trials are to see if it produces an immune response at all. Phase I is to see if it's safe for human use and will it produce a human immune response. Phase II is to determine the best dose in addition to safety and how much of an immune response. Phase III is where we determine if it works, and if it works better than current or standard treatments. Phase IV is really about post-marketing data. Verifying efficacy and side-effects among the general population occurs during this phase, mostly to see how effective it works over time.  Phase IV is done on treatments that have already received FDA approval and is in use in the general population.

There are about 10 years or more between studying something in the lab and getting it to market. So a lot of the nifty new research I talk about here is almost a decade away from ever being found on the store shelves or prescribed by your doctor.

But if you see something labeled "Phase III Clinical Trial", you can start getting excited!