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768754 tn?1373918737

Bummer re: BI 201335 NA Drug Study

Bummer!  Just heard that Europe filled all the slots for the Phase II of this study.  I understand that Dr. Bonacini was not very happy w/this news.  They had 17 people lined up as potential candidates for the study and now have to share the bad news.  Dr. B. apparently went to school with and/or is friends with the primary researcher and will be meeting with him at a conference in Europe in a few weeks.  He will try to secure more slots in the U.S., but it is not guaranteed that this will happen.  From my limited understanding & memory of the conversation I had with the research coordinator, in order to gain FDA approval, the study must include participants from the U.S.  Does this sound accurate?  So, my options are to look at another similar phase II study that will be starting around June, or to wait and hope that Dr. B's office will have guaranteed slots for the phase III that starts in a year.  
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768754 tn?1373918737
I was finally able to click on that link.  This does look promising.  The protease inhibitor ("BI 201335") works by blocking the virus's ability to replicate itself.  If the virus doesn't replicate and viral load goes down at a faster rate than standard of care (SOC) treatment alone, then in theory, patients won't have to endure the SOC drugs for nearly as long.  That would be a wonderful thing.  There are some people who have a genetic resistance to the drug.  Patients in this trial receive genetic testing and they will know if they are in that category or not. (I'm not sure if they are made aware before or after the trial.)  
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768754 tn?1373918737
Thanks for the link.  I was unable to open it.  Maybe the site is being updated?  Can anyone else open the link: http://www.hivandhepatitis.com/2008icr/aasld/docs/111108_c.html ?
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768754 tn?1373918737
I don't think I really answered your question.  From what I understand, they were promised so many spots in the trial.  They finally received the final IRB approval and then found out their spots were already taken.  I guess that can happen.  The doc & clinic staff were understandably pretty darn upset.    
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768754 tn?1373918737
Thanks for mentioning that about the IL site.  I'll check into that one.  
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768754 tn?1373918737
Due to competitive enrollment, the drug trial phase II slots were on a first come, first served basis.  Supposedly this means even if the slots are all filled up in another country.  This doesn't make sense to me.  I don't know if other states were able to get approval sooner.  From what I'm told, some clinics have to go through a local IRB (Internal Review Board), like my doctor's site, and others go through a central IRB.  Sometimes it takes longer to get through a local IRB, and by the time they receive official approval, the other sites have already filled the open seats in the trial.  The research coordinator said they are working on getting secured spots in this trial for the third phase.  

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Avatar universal
I don't really understand what your doctor is saying.  When I look at this trial on clinicaltrials.gov, there are a number of sites in the U.S. that are "not yet recruiting".  

Was he a confirmed trial site and was only allowed a certain quota of patients and he wanted more than that or was he shut down as a trial site?  The Illinois site for this trial says it's "Recruiting" but I don't know how accurate that is.

From what I understand, yes, a drug has to trial in that country to be able to be sold there, at least with regards to the U.S. and Canada.

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806995 tn?1265823176
This BI 201335 protease inhibitor sounds very promising!
http://www.hivandhepatitis.com/2008icr/aasld/docs/111108_c.html
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