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Telaprevir roll-over prove 3

Telaprevir roll-over prove 3


I started prove 3 back in May 2007. I did not pass week 12 (?) criteria and was dropped. I found out a few months ago I was in the placebo group. I am therefore eligible for the roll over.
I was expecting to be rolled over by now but I have heard nothing from the study site except that they will contact me when they are ready to start.
My last dose of treatment was back in the beginning of Augut 2007.  First week of november would be week 24 (time of unblinding).
We are december 11 today.

Anybody else expecting to be rolled over?
Have you started yet?
How long have you waited?

Cheese


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Avatar_n_tn
Hmm...

I might guess I am the only arm A prove 3 subject here based on the messages I have seen to date.
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80575_tn?1207135964
I haven;t heard of another, which is hard to believe.

If you roll over, for how long and with  what combination of drugs?
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Avatar_m_tn
I am also prove 3 arm a had a 3.5 log drop week 12  nov 14 viral loads released to me have had same response as last time i treated went neg between week 20 and 24 last time treated for 72 weeks went neg at week 26 went 46 weeks neg and relapsed i have been told 0 chance of treatment working but in order to qualify for roll over study i must complete trial or wait for drugs to be approved i am in week 31 now i am considering droping out not to happy about having to complete trial with no chance of working having said that i understand they our in the process of starting to recruit patients i think you will find will be begining of 08 have been told will not be blinded and protocol will be 12 triple and 12 soc you should call  january and stay on them they will be recruting all the way into next fall i was told within 90 days of relapse i would start  again but that is because tril will be up and running i finish treatment april 13 i have appointment dec 18 see what i can find out reards
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Avatar_n_tn
jacksonblue
It is unfortunate that one must continue with treatment even knowing it is not going to work. I am happy I did not respond early (passed week 1 with 1 log drop criteria, failed week 12).
Perhaps the bright side is that your viral load might be much lower than usual when you start triple therapy.
I hope it works for you. You responded well in the past.
I on the other hand have never had a recorded 2 log drop in the last 3 or 4 attempts at treatment. I am a "null" or very weak rezponder. Chances for viral mutation/resistance is probably higher for me.

Hang in there.
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Avatar_m_tn
Hello if you go to clinicaltrials.gov enter trial identifier nct00535847 it will show all trial locations  when recruiting there is also call centre number 877634VRTX thanks for your encouragment you will no in first weeks of treatment if any chance of working good luck regards
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208764_tn?1249433257
According to my RN the 'roll over' is at 36 weeks from ARM A so don't quit as you're close to that and if that's correct then you'll quickly respond to the triple tx likely.
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Avatar_m_tn
Thanks i have appoointment on dec 18 i will ask this question rn told me only needs to see me every 8 weeks after week 32 but as per proticol there is appointment week 36 that would make things much easier to take the 36 week may be for people that have had viral breakthrew or droped early regards
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Avatar_n_tn
I've been in contact with one of the study sites for the rollover trial.  They're planning on having their patients begin this trial in January.  I'd call them directly if I were you, just make sure they still know you're interested.
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Avatar_n_tn
Done.
I have asked them twice within the last 2 weeks.
No dates have been mentioned, although over a month ago I was told roll over is expected to start within 3 to 5 weeks.
I have been told I will be contacted. The lack of a start date is maddening.

Cheese.

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