Anyone else on Sprint 2 (Boceprevir) not getting VL results?

I am four shots in to this trial (about to start the PI or placebo) and have been told I won't be getting my VL results because it's a double-blinded study and *they* aren't getting the results. After reading the consent form, it appears that I should be getting VL results if I request them. I emailed the trial coordinator and she said she would talk to me at my next appointment (which is Tuesday). Doesn't sound promising.

This is being done through a hospital and not my doctor and I'm wondering if that's why it's different.

As far as I can tell, everyone else who is on the boceprevir trial is getting their VL results--at least those who are posting, but I'd appreciate knowing whether you are, or aren't if you're on the trial (and whether you're tx naive--like me--or retreating).

I'd really love to have some sense of this before I see her on Tuesday. Thank you. :)

[Rockerforlife]

I am getting all my test results back...PCR and LFT`s....maybe your study nurse is not fully informed...'double blinded ' just means they cant tell you what arm you are in and if you are getting the BOC/plecebo...i cant see why you are being told this..i am a retreater myself...you may have to see your nurses supervisor or go up higher

[Bill1028]

I got my 2 week vl and nothing since and I’m now on my 9th week.   The trial nurse has been in contact with them and is trying to find out why they are being delayed.  It seems that all 10 of us at this location are being withheld and we should get some explanation beside that they are backed up this week.  There has been no talk about it being a blinded study and that the results should and will be released.  Waiting is the hardest part.

[can-do-man]

On my study consent form.... Contacts for Questions or problems

For questions about the study or problems call (has my hospital) Research Compliance Administration office and their phone number.

[tkarasz]

I am getting tested every other week and got all my results back, including enzymes. Unfortunetely, the holidays messed me up so I didn't get tested at week 4 and 5. The week 6 results showed me at UND. I just wish I knew exactly what week I cleared. I know what ya mean, this stuff is important to us. Good Luck.

[GreatBird]

Thanks for posting, Rocker, Bill, Can-do, and tkarasz. I had a feeling it was just me. :(

tkarasz--what version of the trial are you on?

Here's hoping that I can get results without having to make a fuss. I know I could probably bet my GI to run the tests, but I don't think I could get that to happen fast enough for a good 4 week test. We'll see.

[tkarasz]

I'm almost positive it is Respond 2, but I will check this and confirm with you. I do know it is referred to as "double blind". I am also being treated at a hospital, (Henry Fords in Detroit). Also, there are three different arms, and I also started with a 4 week lead in before the BOC. HFH seems to be really open about the info sharing. I'll get back to you.

[virgocharm]

i am in the same study there at henry ford in detroit. in the rules of boc, rather naive or relapser, we are to get all labs if you request them. my nurse always have my labs   for me.

[epiphiny]

I was on a different trial to you guys but I happen to know that they downright told big
fat porkies to us.  We were told we could get our VL results BUT they stalled giving them to us until after the study drug period was over.  They would tell us they weren't back from the lab yet!  Hah!  

After the trial period was over I asked for copies of ALL my labs plus my VLs and they all had the dates on them of when they were faxed to the study centre, and those dates were within the same dates that I was asking for results and they were saying they weren't back... Just thought it worth mentioning as what the form says and the what the peeps do can be a bit different but entirely within the legal bounds.  Just a bit of 'fudging' if you know what I mean...

Btw, my trial was randomized and double blinded and they didn't want anyone knowing the results as it can have an effect on outcomes - power of the mind and all that.  Another difference in my trial was it was triple therapy from Day One, no lead in...

[Bill1028]

How did you visit go?  I did put up a fuss and they are blaming the lab being backed up over the holidays and SP being closed during the holidays.  I told them if I knew that I would not get vl’s until after the study was over that I would have never signed the consent form, and now it is their turn to honor the consent form. They did manage to cough up my 4 week VL which is 2500 and promised that I will get all of the results as soon as they are caught up.

[GreatBird]

Visit went well. Got my numbers, but it's a 'becareful what you wish for' situation. I'll show you:

Screening:  664K
Day 1:  1320K
Wk 2:  940K

And they drew for wk 4.

Herein lies the rub . . . only once have my numbers ever been as high as they were on Day 1 and Wk 2 in the six years I've been tracking my VL. Generally they are around 400-600K and once they were down to 75K.

So I was feeling bummed. Also it's not a tremendous drop and at week two I was still higher than I was at screening day.

Oh well. :sigh: If it was easy, everyone would be doing it, right?

I started on those little blue jobbies and yesterday's shot kicked my you-know-what, so I'm hoping I can keep everything down today. The blue pills do have a yucky aftertaste although I'm not sure I'd describe it as metallic. Then again, I'm not sure how well my mouth is actually interpreting data these days.

Excuse me while I go drink another gallon of water. Slosh.

[GreatBird]

BTW--congrats on getting your numbers!

My nurse explained that she'd just been confused by some other trial they'd been working on and we were meant to get them all along. Would have been nice to say that in email, but all's well that ends well.

[can-do-man]

Between week 2 and week 4 i had hardly no VL drop. not even 1 log. 2 weeks with boceprevir and i was und. So i started out bummed also.

BTW, when i started tx my VL was 200,000 higher then it was at screening a month earlier.......... Best to you

[GreatBird]

Thanks for the encouragement. :)  I'm just hoping these foul-tasting blue things are the real thing. That would definitely help!

[Keith_2008]

I have been getting all my VL test results. It does also state in the contract that you signed to enter treatment that the results will be provided to you upon request. I only thing my trial nurse wont provide is actual copies of the documents, but the will let me write down the info on another piece of paper. If your trial nurse is not providing your test results you need to show her the contract and point out where it say's "test results provided upon request". Also it does not do very much good to get the results after the trial. It's a little to late to do anything by then. I would demand those test results and even threaten to quit the trial if those results are not provided. They really don't want anyone quitting the trial. It becomes a total waste of resources at that point.

[Rockerforlife]

Looks like your nurse is double blinded.