Vertex trial

saw my hep doc last friday and said he was going to a meeting in the next few weeks about new vertex trials. i told him i thought the trials were for non-responders and he said there are also going to be more for people that have never treated. anyone know anything about this? any links i can find info about this. thanks for the help

[FlGuy]

I talked to a VX trail coordinator at a Univ. site a few months back.  She was guessing, based on her expereince with other hcv drug trials and current knowledge of vx, that they'd start recruiting non-naive people maybe around the end of the second quarter of the year. Nothing definite though other that to also guess they'd go afer non-naive geno 1's before other genos.

[mremeet]

The Prove 3 trial is for non-responders. It's should be starting pretty soon I believe (the link below provides a start date of "January '07"). Here's a link with some info:

http://clinicaltrials.gov/ct/show/NCT00420784?order=1

[jmjm530]

For understandable reasons, Vertex appears to be holding everything close to the vest. What you say, doesn't surprise me at all. Best thing is to constantly check multiple sources (weekly if possible) including Vertex itself.

APK,

Wondering if you got back results from your 4-week post treatment test yet? We're all pulling for you.

Be well,

-- Jim

[Imagine]

I have read that the PhaseIII trials are projected sometime the second half of this year.

[mremeet]

It's easy to get confused with the various ways they break these trials down. What Vertex calls the "Prove 3" trial for non-responders, is actually a phase IIb trial.

[crsrph]

    talked to the np and doc at my site fri said prov 3 end march april still waiting for final paper work they already have their slots filled . interesting to note doc said they were going to do a fibroscan trial in a couple of months might give me a chance to resolve our differences of opion on biopsy results low platelets and red palms . phase 3 end of 07 size and pt types will depend on early phase 2 and phase 1 results their best guess

[crsrph]

spleen liver were normal had 2 ct's in 06 alt was 75 ast was 55 vl 10 mil platelets were 120 how ever inr was .92 normal .8 to 1.2 all other labs normal he thought late 3 early 4 i thought 2 early 3 bx came back metavir pn 1 ln 0 activity 1 fibrosis 1 . he got a good sample 30mm no breaks but both of us thinking sample error have been on treatment with vx 950 am stoping soon once i clear tx drugs would like to get a fibroscan of fibrosure to get a better handle on damage present. have had hcv for 26-28 years best guess

[copyman]

crsrph: i must have missed about the opinions on your bx. can you explain what happen? was there a difference somehow? what did they say your bx stage/grade was. what are your stats if you dont mind me asking, including platelets and other labs. enlarged spleen? any other sx besides the red palms?

others: thanks for the replies. i said to my doc 3 times about the vx-950 trials being for NON-responders and he told me 3 times that there will be trials for naive patients starting as well. he said he was going out to a meeting in two weeks and would let me know. he said the trial was very limited. i will let you all know. he is probably wrong and i'm getting my hopes up for nothing like i always do with this disease.

[FlGuy]

I noticed this AM that although most VX trial sites are not yet recruiting for Geno1 'experienced' patients (see clinicaltrials.gov) it appears thay they are recruiting in Gainesville.  I believe that would mean Shands.

[spcecst2]

What if you lie about previous treatment! Just go to a new doctor and say you want to be tested, when it comes back positive say "What the F" and apply for the trial, that way you can list new doctor and you shouldn't need insurance so I don't know how they would know? Will it throw off study, a little, could it save your life??

[pln]

WE are probally in some data base somewhere. Big brother and all.

[FlGuy]

I've wondered that myself.  Can't imagine that there's a blood test that would reveal trace amounts of peg/riba many months after the fact. Dunno.

[chcnme]

Hi copyman.  I recall my doc (several months ago) also said something about the possibility that VX could be doing some trials later on that I might be able to get into.  He wasn't talking about anything possible with the one upcoming for nonresponders  (we had already discussed that I would not be eligible for that since I was not technically not a nonresponder, either), but he did make mention of something "possibly later"  (and to me, it sounded like he meant VX would possibly be testing on other groups - perhaps people who have had a few weeks of treatment).  Just don't know,  but I do remember my doc saying something along the same lines.

Best of luck. Let us know if you hear anything.  

[copyman]

space, sounds like a good idea but they will want to know the doc you treated with and get a report from him. the drug companies that run these trials know there are alot of desperate people out there and know all the tricks. here is my off the wall idea,  how about getting a job at the vertex plant where they make the pills and walking out with a few each day or just take them while standing at the conveyor belt. lol