has anyone been on the trial study for TMC 435?

[cakes8267]

Has anyone participated in the trial study for TMC 435?

[WriteItDown]

Thanks, Dave, that's nice to hear.  So many people on here helped us when we were considering the trial -- if I can help even one other person it will make me feel good!

Will, yeah, they stopped people on my husband's trial if they were not UND by week 12, or if they had any viral rebound at any point. You stopped at 24 if you had RVR on the trial drug.

I guess now thinking about it, I must be wrong about Cakes' trial, though, since I believe relapsers have to do 48 either way....?  In any case if it were me I'd just go for it and get the PCR after the first week, hope for the best and if I got placebo then I could decide what to do accordingly.

Cakes, we're all pulling for you.

[spectda]

I guess in any blinded study the arm you were in is not disclosed until the trial data is complete.

Definately good advice from everyone to suggest private pcrs, especially the 1 week pcr to know if you are getting the goods!

Good luck cakes, knock that beast on it's A$$

-Dave

[spectda]

Those considering the trial are lucky to have the benefit of you and your husbands experience and advice. Congrats to both of you on the great result.

-Dave

[willbb]

  The trial I was in is also not unblinded until the end of the entire study as to what arm you were in that is   usual protocol,however that is somewhat odd to blind your PCR results till the end.


Do they stop you completely if you are not clear by 12 or do they use the old protocol of going to week 24?

[WriteItDown]

Dave, my husband was in the Phase II trial of this drug and received NO viral load info until the end of his tx, and we are even still blinded now as to what arm he was in (he's been done about 18 months now, but the trial is not completely over yet.)  So what Cakes says is likely true, no PCR info.

But they do stop you if you're not clear by week 12.  I think what Cakes means is that if you stop at 24 weeks you know you got the trial drug -- also true.

That is why I advocate getting a private PCR after ONE week -- this drug acts very fast and if you're getting it your viral load drops on average I think 3 - 4 logs after one week. Then you will know if you are on placebo.

[spectda]

"I wouldn't find out my viral load count til the end of research, but they would pull me off the treatment if I clear, so, its rather obvious what drug you got.  I can always go to my primary doctor and get tested.  They keep you on the treatment if you are not clear however.  (und)"

I am sorry to question your comment, but this does not sound correct to me. I have a hard time believing that the fda would approve a study where you continued tx if you were not und at a certain point. For most trials these days that point is 12 weeks.

I am also almost certain that they will provide you with your pcr result at a certain point in tx which again is usually no later then the 12 week pcr.

In any event, I would do the pcr privately at 4,8,12 weeks if they do not provide you with results.

Perhaps one of the people in the previous trials can comment on when their PCR result was disclosed.

Good luck,
Dave