

New Vaginal Gel Prevents AIDS Virus Transmission - chaostheory
http://www.webmd.com/hiv-aids/news/20090304/new-vaginal-gel-stops-aids-virus

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smidwap
Wow PETA is going to be all over this one. But I'm pretty sure monkeys can't
get HIV? It's unique to humans right?

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sam_in_nyc
The other day it was released that scientists developed an HIV strain that can
infect monkeys.

[http://www.sciencedaily.com/releases/2009/03/090302183124.ht...](http://www.sciencedaily.com/releases/2009/03/090302183124.htm)

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josefresco
Which brings up an issue with this 'gel' in which they tested using SIV and
according to the article you posted ...

"...SIV shares only about half of its amino acid sequence with HIV, making it
a very imperfect substitute for testing anti-HIV drugs and vaccines."

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mattjaynes
Let the awkward bedroom conversations commence...

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mojuba
Is this on Hacker News because of the word "Transmission"?

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ivey
It's interesting because it's a novel approach to solving a problem. Instead
of "How do we kill something that's constantly mutating?" this approach is
"How can we make it not a problem in the first place?"

Also, it uses "devices" (odd name for a gel...ain't medicine fun?) that are
already approved, so the time to market can be greatly reduced.

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mojuba
Have you read the last 3 paragraphs in the article?

What they say essentially is "This is just another yellowish PR puke. You will
never hear from us again. Thank you."

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joeyo
I disagree with this sentiment.

There is a huge uphill battle for getting something like this approved for use
in humans and a large part of that is proving that the device is safe as well
as effective. Firstly, we don't even know that this compound will work against
HIV, since they tested it against SIV. Secondly, the gel is something would
have to be applied to the vagina very frequently (think: sex workers) without
causing problems (ie inflammation) that could make infection more likely.
Additionally, the researchers showed that the gel is effective in very
controlled settings-- will it remain effective during intercourse? Finally, I
am not even sure how you ethically do the controlled study in humans to prove
the gel's efficacy. It will have to be designed very carefully, for sure.

I am sure there are many other challenges to bringing this to market that I am
not thinking even of, but they will get there, and I don't think this first
result is insignificant.

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kragen
You could ethically do a poorly-controlled study quite easily, once you're
fairly sure the gel doesn't make things worse: distribute the gel in a dozen
small towns that are paired with other demographically-similar small towns
that you aren't operating in, and look at the HIV surveillance results for
those towns over the following year. Ideally you can also estimate the use of
the gel in the people who became newly infected with HIV (by having their
doctors ask them) and in the people who didn't (by sampling for a survey).

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timr
Companies can (and regularly do) ethical, well-controlled studies on HIV
treatments. It's not new territory.

First, a small-scale phase-I trial is done on otherwise healthy people --
they're just looking for safety, not efficacy. Any indication that the drug
makes things worse, or causes significant health problems, and the drug is
dead.

Once it's established that the candidate drug doesn't make matters worse, test
groups of high-risk individuals are selected from the population: IV drug
users, homosexuals with a history of unprotected sex, etc. They're selected
for as much diversity/balance of demographic data as possible, then randomly
divided into groups by the clinical trial organizer. The participants are
given extensive counseling on HIV prevention, condoms, safe sex, etc.

The groups are then used to construct a double-blind trial, where neither the
patients nor the physicians are aware of who is given placebos. Outcomes are
continuously monitored, and if there's any indication that the drug _raises_
incidence of HIV, the trial is terminated early.

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joeyo
Really? You can give them a placebo and say, "This might reduce your risk of
HIV or it might not. Have fun!"

I'm curious because my impression is that most drug trials have been for AIDS
_treatments_ (where, perhaps, placebos are more ethically acceptable--
especially before the treatment is known to be better than the placebo) rather
than HIV _prevention_.

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timr
Short answer: yes.

I'm not an expert on the ethics, but pretty much every vaccine trial faces
this dilemma. The solution is to make sure that the trial participants are
fully informed (i.e. they've got to know that they may not be getting a real
vaccine), and to make sure that the vaccine in question doesn't make things
_worse_.

If you can do those two things, then in the worst case, the participants are
no worse off than if they hadn't participated in the trial at all. But as I
said, clinical trials for things like HIV vaccines tend to go above and
beyond, and do things like safe-sex counseling for every participant.

