How do you get enrolled in a trial?

[budburma]

I am interested in getting into a phase 3 treatment trial including telaprevir, but can't seem to find the exact locations or phone numbers for the sites listed as recruiting on clinicaltrials.gov.  Vertex was equally unhelpful.  How would I contact any of the NYC centers for possible enrollment.  Any other promising protease inhibitor trial coming up shortly?

[aungkyawsan]

Hi Budburma, (And All)

Accept my apology If you all think I am wasting your time. I am interested your name as there is "burma" in it and I am from Burma. Something to do with this?
Aung
Burma

[budburma]

My friend and hepatologist spoke with the drug rep for Vertex and she is looking into it for me.  I called the GI departments in the larger Bronx, NY hospital's (Montefiore and Jacobi) and have gotten no info as of yet.

I live about 2 hours for the Bronx and about the same to Morristown, NJ and would certainly be willing to do the drive...or my wife would if I was in lousy shape.  My life is not in the best place for treatment, but I don't really see it slowing down any time soon.  So, I guess I'll just have to be persistent!

Any study site or principal investigator's numbers located from NYC and north to Albany or in nothern NJ would be very appreciated.

Thanks for your help.

[lapis]

I saw my hepatologist the first of October for a routine visit, we discussed tx, and he told me then that the clinic was recruiting for a Telaprevir trial.  After a short wait the study coordinator came to screen me, I had labs drawn, a physical, etc.  I'd had a bx 17 months previously (G2 ST2) but was required to have had a bx within 12 months, so had to repeat that procedure (and learned that my bx had improved, had gone to G1 ST1-2!!).  In a short 23 days from the hepatologist visit I'd started tx!

Since joining this site I've really appreciated my good fortune in getting right into a trial.  And the timing was right for my life, too.  You've said you have a friend who's a GI doc, that does sound like a good place to start, in addition to your own hepatologist or gastroenterologist.  Sorry that I don't have more ideas about how to find a study in your area, but I sure wish you the best of luck in finding one.  Glad to speak to you further if you have any other questions.

Lapis

[budburma]

You're well come, no worries.  You should actually thank Uncle Sam who demanded all current research at the time be shared because of the scope of the epidemic.  We were at a bit of a dead end with actual delivery of the drug and the company I worked for never got a drug out to human trial!  Plenty of others did, though.

So, my last biopsy was about 7 years ago and showed minimal changes only with very small areas of piecemeal necrosis and some rare bridging, but no fibrosis.  I just had a repeat viral load done to prep myself for a possible trial if I can find one.

Good news about the depression bad news about the multiple relapses.  Maybe a trial for treatment failures with one the protease inhibitors is a good idea for you!

We moved out here to the Hudson Valley in NY in '98 from Sac city......fond memories of seeing the signs for Placerville.....

Peace.

[Bill1954]

Boy; speaking of Karma, huh :o)? Sorry to hear you have to deal with this… but thanks for your early efforts. The new small molecule products look promising; we’ve had a number of trial participants in here from some of the original phase 2 stuff, and others that are currently enrolled; hopefully, one of them will stop by with some more contact info for you.

I have treated twice, for extended periods; and have been dealing with on and off depression for years. Personally, treatment did not seem to exacerbate any existing depression; of course, your mileage may vary.  

Have you had a recent biopsy? How is your current histology?

Good luck going forward, and thanks again for the HIV work; that groundwork might have helped save our goose :o).

Bill

[budburma]

Thanks for the quick response.  Yes, I saw the Boceprevir and the Telaprevir trials both with 'recruiting' sites on clinicaltrials.gov but nothing beyond city and state to actually contact them.  I have a friend who is a GI in Syracuse that I'll give a call to.....
Funny, I actually helped develop the retroviral protease inhibitors used to treat HIV in the mid-80's and now they are coming around to hopefully help me out.

[Bill1954]

Watch this thread; others might stop by with information for you. Have you discussed this with your doctor? He should be able to connect you, assuming you fit the inclusion criteria.
There are a number of other drugs currently in development; have you looked at any of the Boceprevir trials yet? I believe they are currently recruiting, and the drug looks very promising as well.

Bill