Phase II VX950

here is the info on the Phase II VX950 study

http://clinicaltrials.gov/ct/show/NCT00420784?order=67

[GrandOak]

Thx for sharing.  Interesting to see that it's still in Phase 2 as it would seem to push it's release out a few more years.

I also find it interesting that the start date for the study is listed as January of 2007, that it was verified by parent company in January of 2007, it is now January 2007, it is listed as not yet accepting patients, and the month is half over.  Since it takes 6-7 days just to run PCR's one would think that they would have to start the recruitment process soon.  Maybe they think that there's so many chomping at the bit to be their test subjects that it won't take long to reach their expected 440 enrollment.

[APKhaos]

GO said, "Since it takes 6-7 days just to run PCR's one would think that they would have to start the recruitment process soon. Maybe they think that there's so many chomping at the bit to be their test subjects that it won't take long to reach their expected 440 enrollment."

I think you'll find that most participating clinics will draw subjects from their existing patient list. We discussed this before - its important to be on the clinic's list as early as possible. I went to my clinic for a second opinion on tx after dx and bx, and being told by the hepatologist that did the bx that SOC was the only choice.  It was during that consult that they opened up discussion on participating in the VX trial. That was maybe 9 months before the trial actually began dosing.

[GrandOak]

If one is able to find out which clinic you need to visit so you can get on the list in order to be able to participate.

If you call the number indicated at clinicaltrial website posting you get Vertex which tells you to go to clinicaltrial website, which only gives you the Vertex number.  But I guess redunancy and running in circles seems to be all one can expect from a government entity.

[FlGuy]

In August, about the time when pds, pln, apk, lab and Mr. E were all starting, I went to see the liverhead at a local Univ. They are a vx site.  After exploring the possibility of vx with the doc, who did not see anything that would eliminate me from vx trial, he put me in contact with the local vx coordinator.  At their site they don't really look back at patient lists - they don't know what those patients were up to after maybe months of no contact.  Instead, they recruit from those who are more recent contactors.  The coordinator urged me to stay in touch with her to keep my name/particulars in front of her.  As a g3 relapser, vx opportunities were (and are) still several months away and the liverhead said I can't wait.  The moral of the story is, don't be passive - be very active, make yourself known, make them remember you. Stay just on the gentle side of being a pain.

[crsrph]

they were refering to the phase 2 prove 1 trial arm A which got only soc (about 70-80 people) if they did not respond to soc they would be given the opportunity to get into the prove 3 trial and receive the vx950 in this trial if they so wished. could be a along time on treatmenet with little or no break for 70 weeks for some of the prove 1 arm A people if they so chose

[mremeet]

For what it's worth, the scheduled induction and start dates for the Prove 1 trial were later than initially reported. I was really getting apprehensive about it because the website and various newslinks were reporting that recruitment had already begun - but then I would call Vertex and they'd say "it's been postponed, call back later." Later, after getting really nervous about the discrepancy between what I was reading online and what Vertex was telling me (concerning recruitment and start dates), I decided to look into it myself. As discussed before, I tracked down a (suspected) trial center on my own in my area (with no help from vertex). I discovered that in fact recruitment had already commenced and that if I wanted to enroll I'd better get on the stick and come in for screening ASAP. From what I've seen with most other enrolled trial participants, they just happened to be in the right place at the right time. They were usually existing patients, who just happened to be visiting with their hepatologists around that timeframe. And their hepatologists just happened to be participating in the trial. Plus they just happened to meet the admission criteria, and just happened to be solicited and recruited by their doctors to participate.

What that means for anyone who "just happens" to not find themselves in these (fortunate) shoes, is that you have to make your own luck. I can tell you're hungry to get into this trial GO - that's good! But if I were you, I'd hit the phones hard and try to get info from research hospitals in your area (that are likely to be participating). If you can get someone on the horn, then make an appointment and keep calling them to follow up and remind them you want in (politely, but *persistently*). If you don't have any luck on the phone, then actually physically go there and walk around. Talk to people and ask questions. Sooner or later you'll get to the bottom of it and establish some meaningful contacts. Remember, since you're not already "in the right place at the right time" like most other participants, you have to willfully orchestrate putting yourself into the right place at the right time. Even with me doing that, I was patient number 7 (out of 9), I almost didn't get in due to the early birds who had already largely filled up the ranks by fortunate happenstance. Bottomline, don't give up and stay at it - if you really want it, go after it aggressively and don't take no for an answer!

Best of luck, go git 'em!

[hep62pj]

i think it is strange too, why not recruiting yet??  and why only one facility listed , i would think they would be trialing this one all over ... its for non-responders if i read it correct and also for those who have never been treated with a protease inhibitor so doesnt that let out their 'patient' base from phase I?

[FlGuy]

I just had a call from the clinical trial people at the university where I had a consult with a liverhead a few months back.  The were checking in with me to ask if I would be interested in a clinical trial that is starting up using Albuferon (intended replacement for Peg). Since it's for tx naive people (I'm on tx) I don't qualify. The point is, that if I didn't make my interest known to them, they never would know who I was.  And, the trial they solicited me for is not even list on clinicaltrials.gov yet.  It pays to network a bit.

[APKhaos]

FLguy has it right. The more available, cooperative and patient you are in dealing with the trial site, the better are your chances of being up towards to top of their selection list. Trial sites want subjects who are motivated to participate in the trial, and are likely to stay the course [damn, that was a bad choice of words!]