how do you get into a trial ?

[HappyDeb]

...... and is there still trials going on  for the new drugs? I know that i am getting alittle ahead of myself, but you see, I like so many others lost my job last year, exhusted my unemployment and now I am afraid of the cost of tx. I do have ins. but a high deductable. Is anyone out there that has, or is, going through what I tried to explain? I guess what I am saying is that..... I NEED HELP !!! to try and figure things out and see my options. I have not been on here for so long and you all are better knowledged then the Dr.s out there. Thank you for your time and wisdom.

[spectda]

Hi Deb-
The trial I posted for you with vaniprevir looks like it might work for you because they take people who have treated before which is somewhat less common. You would have to travel pretty far to get there. I travel 4.5 hrs each way every two weeks for my boceprevir trial, but thought it was worth it although a hassle. You may want to talk to your doctor about it. I believe that Merck is developing this drug thinking it will be better then boceprevir. I am not sure the trial is still open although it says recruiting.

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00704405

Good luck-Dave

[Isobella]

I'm with you on that, Debbie. I'm a child of the 80's myself, lol!  

I was just worried that someone who did drink within the past year would be discouraged from seeking help through a trial if they read that.  

Good luck to you in findng a trial.  I was very pleased with the care I received from Vertex for my tx.  

Please keep us posted on what you find.

Isobella

[HappyDeb]

Just a little clarity on my lifestyle......... I do not drink, nor take drugs , nor smoke cigerettes ( well, I quit 4 months ago ) I have been addicted to my two daughters for 24 years, my animals for my whole life ( I own dogs @ horses, and other species threw out my life ) ) . I live a clean lifestyle for my well being... no meats, whole wheat pasta, breads, all veggies, fruits, honey for my sweetner ( no artifitial sugar or any thing for that fact ) exercise, yoga, walking with my poochies ....... I am sure there is more I do for myself , but it is getting boring for the normal Joe, so that being said... I know there will be people ready to say " Oh ya, so how did you get HCV if you have such a clean life style ? " I did dabble with cocaine in the 80's DISCO era when I was a nieve teenager trying to fit into the rich and famous era. You know champagne,VIP, limos @ the pretty white powder !!! Did not go that route for long, but it only takes one time and some bad luck to get infected. That's my story and I am sticking to it........ LOL..peace, Debbie

[Isobella]

" Let me go back you must be drug and alchol free for one year Mininum."

Not necessarily true.  My trial did not have those limitations. They didn't drug test during the trial, either.  I'm not advocating drinking and drugging in any way, shape or form, ..but I specifically asked my center about that for a member here that was worried about smoking weed during his tx in the trial.

HappyDeb...  Research the trials thoroughly before signing up.  It can be a great deal moneywise.  Just be certain you understand all the arms and criteria as far as SOC, rescue drugs and dose reducing.  Good luck to you,

Isobella

[banarep]

i have been in two trials.  check the clinical trials web site and check out any teaching hospitals in your area.  that is how i found both of mine, going to hospital web sites.

[mdwypro]

First you need to be near a good hospital or University that does Trials. Your new doctor can guide you. Then the insttution will employ study nurses. Let me go back you must be drug and alchol free for one year Mininumn.You then give the study nurse your history (with doctors reference). Then email her and cal her ocasionaly. She or he should tell you what studies you may be a candidate for. Then let her now your around and sober. I Tried to get in study in October 2008, I started in Feb 2010 TMC435 I am lucky. I was also pleasent to people. I feel I won the lotto.

Chicago

[can-do-man]

I so agree about understanding everything before jumping into any trial, just ask longtime member here susan400............ Good luck but be very careful, i still think you best bet is to wait till the pi's come to market. As with SOC drugs i'm sure there will be help to pay for them.

can

[Bill1954]

Deb, most HCV trials have what they call ‘control arms’; these are there so that researchers can compare results to a non-experimental drug.

Most, if not all of the new protease-polymerase inhibitor drug trials now include active drugs in all control arms. That is, at minimum you’ll receive at least the standard of care (interferon/ribavirin), but perhaps not the experimental drug being studied.

This is only one of the reasons you should have a medical expert such as your doctor guide you thought trial selection; there’s quite a bit of info to weigh.

Good luck—

--Bill

[HappyDeb]

That's crazy.....I was not aware of the placebo end of it. Wow , so you don't know if your the one picked for the real stuff or the fake stuff !!! That's crazy , if that is what I understood

[Rockerforlife]

I was in a trial and it was a 80% chance id get the real deal.i did thank God.I think 80% odds are the average,there are trials thats are "open",meaning they tell your gettn the real drug too.

[spectda]

Remember, in most trials there is not guarantee that you won't get the placebo. At least you will still get the standard drugs for free if that is part of the treatment. Sometimes the drug companies will have another trial for the people that got the placebo and didn't respond to the regular drugs.

[spectda]

I searched the trials at clinicaltrials.gov for you that are in florida and say they are recruiting or will be recruiting, sometimes the trial sponsor has not updated the information and they are no longer recruiting.

You have to look for what applies to you. Often they only want treatment naive people. the heading will give you a summary of who they are looking for. If you click into the trial you will see more detailed information about what they require, inclusion and exclusion information, what the treatment is in terms of length of time and, what the percentage of people that may get a placebo, and a lot of other information.

You had asked on another thread, and unfortunately I believe there is nothing available for boceprevir or telaprevir that will work for you since you, and they may be completing all their trials before submitting applications to the FDA. It's still worth talking to your dr about to make sure they don't have some inside information about something coming up. At least it won't be that long before the drugs are available and it sounds like you have time from your previous posts.

The only trial I could find that looks like it may work for you is one for treatment experienced, geno 1 people using vaneprevir
here is the link, but it is very far away from you although in florida, also remember that you have to call to insure they are really recruiting. - Good luck with everything-Dave

Vaniprevir study:
http://www.clinicaltrials.gov/ct2/show/NCT00704405?term=hcv&recr=Open&state1=NA%3AUS%3AFL&phase=123&rank=17

All open studies:
http://www.clinicaltrials.gov/ct2/results?term=hcv&recr=Open&rslt=&type=&cond=&intr=&outc=&lead=&spons=&id=&state1=NA%3AUS%3AFL&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&phase=1&phase=2&phase=3&rcv_s=&rcv_e=&lup_s=&lup_e=

[Bill1954]

Hi Debbie—

I remember you from years past in here. Probably the best way to find a clinical trial that’s suitable for you is to ask your doctor, and have him/her check to see what’s available. There are definitely pros and cons involved in trial participation, and unless you’re *very* well informed, it’s difficult to weigh the options properly.

If high copays are a problem for you, it’s understandable, and a trial might be a good option to consider. You are aware though, that help is often available for the meds? If you don’t have insurance, or can’t afford the copay, the mfgrs will often send the meds for free from their respective patient assistance programs:

Pegassist (Roche Pegasys system): 1-877-734-2797

Commitment to Care (Schering- Plough PEG-Intron system): 1-800-521-7157

The meds comprise a good portion of treatment costs, so keep these numbers handy just in case.

There are websites that list clinical trials too; the best known is probably this one:

http://clinicaltrials.gov/

But again, unless you’re very knowledgeable, it’s hard to weed through all the requirements. You can take a peek in there, and perhaps someone in here can lend a hand finding one that’s suitable; you can discuss it with your doctor in more detail after that.

Best to you,

--Bill