telprivar relapse

[Debbie556]

I posted this morning about my husband being told at wk 24 he had not met the req. to continue in they study or he had e RVR. We know he was non detectable at week seven and have been told up to that point that he was doing "the best in the study" all his levels that they did give to his Dr were great. Monday we went in and was told he relapsed and was only going to do the follow up. I have read all the paperwork from Vertex and do understand that they can stop the treatment for two reasons : one you have relapsed or you have no dectable level in you system and they are just monitoring you for the next 48 wks.  They also say you will remain on treatment for the full 48wks either way unless you are clean.I am not sure if his Dr just said he relapsed at this time because we did get blood work done at 7 wks and told him he was clear by the outside testing. We are getting him tested asap either way. I just don't understand because this is a double blind study and his Dr does not have the actual results....

[Debbie556]

I am totally lost on what you are saying ........very bad with texting too LOL...

[portann]

When was the first time you disclosed your outside testing to anyone associated with the trial? Was it before the doc told your husband about  finishing tx at 24? Or was it  only afterwards?

[Debbie556]

you are right.. we can test they can only use their results to hand over to the FDA. It still would not exclude him from continuing the test. Bad wording and miscommuntcation is to blame here I think. His Dr would not know he relapsed unless he had access to his viril loads and the rest of the blood work. THAT would be against protocol.....

[jacksonblue]

if neg before week 4 and at 12 done week 24
if neg week 4 to 12 go to 48
if placebo arm i believe min 2 log drop week 12 go to 24 if neg 24 go to48
anytime viral brekthrough done
on prove 3 had 3 log drop week 12 week 20 under 30 detected week 24 neg went full 48 relapsed

[Debbie556]

We didn't actually admit to having it done.. I know that is bad on My part. I asked his Dr what the results might be. I had taken the patient info off the top and gave it to him. He then said the person did not have the virus. It was not until later that I told him it was my husbands results. After reading the consent form it does NOT say anywhere that you cannot get the test done or tell the Dr about it.

[jmjm530]

Having blood tests outside of the study is a protocol violation.
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Not necessarily true. Depends on trial and I'm pretty sure Vertex allows outside testing it's just that they will only test per protocol