Co-infection studies?

[sauteedliver]

Have just been rejected for a La Jolla phase 3 trial for Ifn previous treatment failures. The coordinator took lots of info from me and then told me co-infection patients were not allowed despite the fact that the trial listing was for failed or non-responder patients and HIV co-infection was not listed as a disqualifying condition. I have exhausted all options, been on Ifn riba for 10 years now, intermittent, repeated rebound, until the bone marrow has collapsed. Last treatment had me on neupogen constantly which causes it's own harmful side effects, with constant low white count. I am unable to tolerate any of the HIV meds as they are for me all hepatotoxic within a matter of days, probabaly a result of the HCV. Consequently the T cell count is dropping, at about 500 now. Below that the HCV accelerates, and 5 biopsies have returned stages 1, 2 and 3 fibrosis scores, so the histology is all over the place. Looks like I'm soon to be pushing up daisies. Not soon enough. Torturous really. All of it.  Could be worse, I could have Parkinsons, MS or Alzheimers...or all three. Or be the guy who had no shoes AND no feet. Somehow that old addage doesn't cheer me...
They tell me the HCV protease inhibitors are fast tracked, a couple, maybe just one, and to-market time looks like 6 years from inception! If that's fast tracked I'd hate to see the slow boat to China. HIV PIs were something less than 5 years from inception to market.
So, anybody know of any co-infection studies (which I probably won't be accepted for anyway due to the conditon in which Ifn has left me and because my luck ran out some time back along with Nixon's) ? Seems with some 30 to 40% of HIV patients also HCV co-infected there'd be at least some investigation into this population.  That makes about 300 to 400K in the U.S. alone.

[jmjm530]

as Willie suggests, make sure you include this many stats as possible including genotype, stage, etc.

[jmjm530]

you might want to pose the same question to Dr. Dietrich in our expert form. He is a world renowned expert in HCV/HIV co-infection. There is a small fee to post your question but well worth it being able to access such a knowledgeable expert.
http://www.medhelp.org/forums/show/272

[Willy50]

I have not heard Vertex speak about co-infected studies.  I see that they will be starting a trial for TVR and several HIV drugs on healthy volunteers.  This suggests that they may just be starting.

It also appears that several trials that are recruiting do list the presence of HIVantibodies as an reason for refusal into the trial.

I understand that this may be a potential chance at getting cleared of HCV but the treatment is pretty rough and there remains a question as to whether you could stay in the trial, so I wouldn't consider that it is a "given" even if there were a trial.  If your bone marrow has "collapsed" it may make any form of TX problematic.

This drug should hit the market in about 2 years....or rather; no sooner than 2 years.  there remains a chance that the FDA could approve it earlier.  IF so since past treatment failures would be that group you would qualify....it would seem....if a doctor would agree to prescribe it (based on your other vitals).

One other potential drug available NOW might be Alinia from Romark.  The clinical name I believe is nitazoxinide.  I would do a google search on the net and also inside this board and you will get lots of reading.  This is a drug which is already approved and has been shown to increase response with IFN & RBV.  It even has shown some promise with IFN leaving out the ribiviren.  If your bone marrow is compromised this may be worth a look.

You might also consider mentioning your genotype, staging and other complications you are having in any future posts.  

Sorry that I don't have better news but there are a few hopes and possibilities.

best,
Willy

[sauteedliver]

To clarify...I was rejected for a study of VX 950 and interferon. I require an HCV protease inhibitor study for co-infected patients.