VX Non-Responder Trial Update

Got an update on the US non-responder trial today.

The study coordinators from each participating site are being trained in December. This means that the basic protocol, consent, and selection criteria will be completed by then.

Enrollments will begin after the training, with first dosing probably around March or later [a guess based on how long the Prove 1 treatment-naive trial took between training dosing.

My advice, FWIW:
If you are interested, then NOW is the time to register yourself as a willing and interested potential subject. Don't wait until everything is locked down. Get on the list now. You can withdraw your name if you don't meet the selection criteria or if the trial protocol does not work for your circumstances.

Good luck!

Also FWIW, I finish week 20 of the treatment naive trial in four short weeks! Should finally see PCR results from the start of the trial, and see which Arm of the trial I'm in. There are five or six others here who will be hitting this milestone soon. Exciting times!!

[couldn't think of a nickname]

How are you feeling 16 weeks in, as far as symptoms and sides?

Hope you are well.

[copyman]

thanks for the update. i'm also curious about any sides you may of had, especially about that bad rash some claimed they got while on the VX trial? best of luck to you and please keep us up to date

[GrandOak]

Please tell, just where does one go to express an interest in being a participant?  Clinictrials and even Vertex do not seem to be any help in providing any direction in how to do this.

If the pharmacutical company takes a month to respond to such an inquiry in such a manner as to shed absolutely no light in this direction, then where does one turn?

[illo]

http://clinicaltrials.gov/ct/gui/action/FindCondition?ui=D006526&recruiting=true

Try this site.

[APKhaos]

First, the full disclosure stuff: I have no connection whatever with Vertex aside from being a subject in the Prove 1 trial. I'm just an engaged hepper, and nothing more than that.

Now, my guess is that Vertex won't engage until the trial is set up and ready to start. They need to get a raft of stuff done, reviewed, and approved before the trial is actually a reality in FDA terms.

That said, at least some of the sites that will participate in the non-responder trial are already preparing. They won't formally enroll subjects until the trial is official. When that time comes, the chances are that most sites will already have a full book of potential subjects, and will select their group based on the selection criteria and what they already know about the subjects. All I'm saying is that anyone who wants to get into that first list of potential subjects should be doing it now.

Who do you talk to? Its probably a good start to talk to a clinic closest to your home that is running a subject group in the Prove 1 trial. Its not a lead pipe cinch that Prove 1 sites will become sites for the non-responder trial, but its not a bad starting point! Trouble is, I don't know where more than maybe three Prove 1 sites are located, and I don't know how you would find that information aside from getting it from subjects in the Prove 1 trial. Is there someone you know in your area in the current trial??

Maybe I'm just irritating you with this, but just maybe it might help some non-responders who are interested in the trial.

[couldn't think of a nickname]

VRTX told me before that they have to stay out of the area of participants in their trial, they leave that up to the centers. They do that to maintain a clean trial, etc. You might also call and ask if they could at least point you in the right direction, as to who or where to call.
Good luck.

[GrandOak]

I'm in the Twin Cities (Minneapolis/ St. Paul) metropolitan area of Minnesota.  I believe the Mayo in Rochester was a trial site and had a lead on a potential contact there, but any more solid leads and POC's would be greatly appreciated.

While VX does not appear to be all that promising for a nonresponder as myself, the results I've seen published on it do look more promising than existing therapies.

For me the CIFN and Albuferon meds are looking more promising, but I am keeping my options open for anything Man may be developing where medical science may provide some hope.

Much thanks for any assistance you can provide.

[APKhaos]

Lets dial it down before you start questioning anyone's competence.

Lets summarise all the above:

1. The non-responder trial will not formally start until all the trial design and documentation is completed, reviewed, and approved by FDA.

2. Until that happens, the trial does not exist. That's why it is not on the Clinicaltrial site or anywhere else. It also explains why the folks at Vertex don't have details, and won't until the trial is approved.

3. The company running a clinical trial cannot get involved in the selection or recommendation of subjects, for obvious ethical reasons.

Please don't question competency based on your assumptions which may not be accurate. It sounds like what you were expecting was never going to be the case, and the three points above are the reasons why.

I posted all this in good faith, and tried to make it clear that this was an early heads up. If you don't like it, don't use it. Just because you don't like it doesn't change the fact that it is accurate. Sorry.

[GrandOak]

Competancy questioned base upon timelyness.  One month to respond to an email and no response to phone message is rather long.  Also, responding to inquiries with start-up information 3 months after the trial has begun is not a good sign of being on top of it.

You provided information which appears to be coming from some inside track as it does not seem to be readily available, even from Vertex despite the fact that ClinicalTrials directs all inquiries to them for current trial information.  You also gave the advice: "If you are interested, then NOW is the time to register yourself as a willing and interested potential subject. Don't wait until everything is locked down. Get on the list now. You can withdraw your name if you don't meet the selection criteria or if the trial protocol does not work for your circumstances.".

All I asked for was direction to find out were one might accomplish this and you respond with suggestion to find clinic close by conducting PROVE 1 trials, yet this list too seems to be difficult to find.

All I am looking for here is to follow your suggestion by asking for leads as to where anyone can find any information on where current trials are being conducted with the hope that perhaps they will be conducting the non-responder trials.  Yet it seems like no one can provide clear direction on where this information might be attained.  How can one "use it" when if it provides no direction on how?

[willows]

Hugs and kisses to you for the info, I will do my best to find out where the trial is in my area.  The heads up is wonderful, I knew I would eventually be here, I guess I am lucky, I have a doc who will help me sort out where and how to register.

Your help is appreciated, now I've got that magic ingredient to stay positive, something to look forward to!!  Never comes easy tho, always takes a bit of work.  Good luck to you on the next PCR, Hep C has taught me much patience, self-reliance and gratitude for the small things.  Thanks!!

Willow

[crsrph]

i pulled out the list of vx950 sites i had for trials 2b most of these will also host the non responder trials  where do you live state &city i will tell you wich sites may be close

[APKhaos]

Didn't know that such a list even existed in the wild. That's definitely the best source for people wanting to get on the early list for the non-responder trial.

Thanks much for that very nice get!

[GrandOak]

The reason I asked is that your advice was to get registered, but how can one register if they do not know where to register.

I guess it was my typo, but I've tried Clinicaltrial site several times and they best they can do is show that Phase 2 is still recruiting for a start in August of 2006, but wait it's November already so it would appear that "current" is not a label to be used with this site.

I've tried both email and phone calls to Vertex and the best response was an email one month (Nov 6, 2006)later pointing to ClinicalTrials for the start of Phase 2 for enrollment in the trial to begin last August and that Phase 3 would begin "later this year". But given that it's already mid-November, I'm not sure how much later there is in this year.  I guess I should be thankfull that they are pointing me to the nearly completed Phase 2 trials instead of the already completed Phase 1 trials as it puts them somewhat within the most current half of the year we are in.

Given all out of date responses and lack of information for current and upcoming trials, it really has me questioning the competency and reliability of those coordinating these trials.

[crsrph]

you have about as much info as i do it stated minnesota mayo clinic rochester  call for info . but gives no phone number or contact person . near by only froedtert memorial luthern hospital in milwaukee wisconsin which looks to be a hell of a drive . keep checking  your contact at mayo in rochester after4-5 calls I finaly got someone that got me on the list for treatement niave and was last one at our site to start 2b of vx 950 . KNOW you had a hard time on non response to 1st tx wish you sucess and the best