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Author Topic: Starting VRX496  (Read 45051 times)

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Offline appleboy

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  • Posts: 344
  • Just me!
Starting VRX496
« on: April 30, 2007, 05:14:52 PM »
I just accepted a slot in the VRX496 study.  For those that don't know what VRX496 is:  It is where they pull T cells and genetically alter them to fight HIV.  They use your own T cells.  I go for the intake on June 13th.  I am scared yet so excited of what this could do for us fighting HIV.  If you want to see how VRX496 works go to http://www.virxsys.com/pages/human-therapies/first-clinical-application/how-vrx496-works.php .  Never would I have dreamed that I would want to try testing of medication or even gene therapy but the more I think about it the more I want to help by being active in the research.  I honestly cannot think of a better way to give back to my fellow HIVers and those that may follow.  Feel free to message me and I will go into some of the details of the study from the documentation that I have read. 
Appleboy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline bmancanfly

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  • Posts: 554
  • Medicare For All !
Re: Starting VRX496
« Reply #1 on: April 30, 2007, 06:24:47 PM »
Thanks for volunteering for this.  Let me express my appreciation.
A few questions.  What phase is this study in?  Where is it going on?  Any info that you feel comfortable sharing would be greatly appreciated.

Some previous gene therapy studies have seemed to mysteriously disappeared without a trace.  So any news about a promising study would be great news.

Again thanks for your participation.
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline Jake72

  • Member
  • Posts: 145
Re: Starting VRX496
« Reply #2 on: April 30, 2007, 08:17:25 PM »
Let me add my appreciation and wish you luck on the study!

Will you be taking HAART while on the study or are you discontinuing it (or perhaps you've never been on HAART)?

Again, good luck, and please do keep us posted.

Offline appleboy

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Re: Starting VRX496
« Reply #3 on: April 30, 2007, 09:59:49 PM »
Lets see.  This part of the study is on people that are under control with HAART.  Right now I am undetectable with the ultra sensitive test.  My CD4 is 517.  This part is also supposed to be doing it with multiple injections of the VRX496 modified T Cells.  If all goes well at some part of this I should be able to stop my Atripla.  The study is being done at the University of Pennsylvania Hospital in Philadelphia.  This is great because my ID Dr. is also close to the group doing the study so she can watch while all this goes on.  Thanks for the support as there is some parts of this I don't want to do like the Anal Biopsies.  So I think I am going to make a shirt to wear for 4 anal biopsies that reads "I am taking one for the team".  Thank you both for your support and warmth.  That really means a lot to me.  If I have not answered your questions let me know and I will try to do better.
AppleBoy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline Jake72

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  • Posts: 145
Re: Starting VRX496
« Reply #4 on: April 30, 2007, 10:11:11 PM »
Thanks for your detailed answers.  You definitely have our support!
Is this a Phase 2 study?  Phase 1?

Offline J220

  • Member
  • Posts: 587
Re: Starting VRX496
« Reply #5 on: April 30, 2007, 10:28:35 PM »
From what I have read this therapy sounds real good, I support your decision, and thank you as well, for "taking one for the team"!

The data that has been put out by Virxsys is extremely encouraging, and the best part about therapy like this is that as time goes by it works better and better, as the modified cells multiply, and as infected cells die off and/or neutralized.

They may have a winner here...only problem it seems to be expensive, and somewhat complex, with the need to harvest and modify the t-cells. But, let's focus on the plus side for now. Do keep us updated, maybe you can have a blog where you can detail your experiences.

Best of luck!!! J.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline appleboy

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  • Just me!
Re: Starting VRX496
« Reply #6 on: April 30, 2007, 10:57:34 PM »
Thought about the blog thing but not sure where to put it.  This is a Phase I/II study as I just found that in the documentation. 
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline J220

  • Member
  • Posts: 587
Re: Starting VRX496
« Reply #7 on: April 30, 2007, 11:54:00 PM »
You can always ask the people here at Poz, to see if they are interested in you having a blog here. In any case, if that doesn't work out, you can post regularly on the forums once the trial begins. I'm excited for you!!! I think it's going to work great.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline appleboy

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  • Just me!
Re: Starting VRX496
« Reply #8 on: May 01, 2007, 11:08:34 AM »
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline krh

  • Member
  • Posts: 36
Re: Starting VRX496
« Reply #9 on: May 01, 2007, 11:53:37 AM »
Hey Appleboy:

I was considering this trial myself, as I really believe that it will produce solid results.  I am also in a similiar position with you as my tcells are around 400-500 and VL undetec.  I've been pos for about 4 years and very healthy.  Except that while on Viramune I had some liver issues so decided not to do the trial.

I think it's a good trial.  My biggest issue was possible cancer from modifying the tcell's, but the vector technology seems to have been almost, if not perfected.  Also the Phase I results were very promising and the people in the study haven't had any issues.

Keep us informed, you might be off meds for a long time.!

Offline appleboy

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  • Just me!
Re: Starting VRX496
« Reply #10 on: May 01, 2007, 11:59:38 AM »
The cancer thing scares me too.  But I am willing to take one for the team!  That is my new slogan I am using now.  I also remember the saying we have nothing to fear but fear itself so, I am trying not to let the possible unknowns to make me scared.  I will do my best to keep my blog up on what is going on through the study for those that are interested in following VRX496.
AppleBoy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline Jake72

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  • Posts: 145
Re: Starting VRX496
« Reply #11 on: May 01, 2007, 02:24:35 PM »
Keeping a blog at http://appleboyde.wordpress.com/

Right on, Appleboy.  I've added it to my "Favorites."

I understand your fears, but keep in mind that they'll be monitoring you very closely.  At the earliest suggestion that something may be going awry, I'd guess that they'd take you off the study and get you any needed treatment.

Offline NYCguy

  • Member
  • Posts: 180
Re: Starting VRX496
« Reply #12 on: May 01, 2007, 02:57:17 PM »
Appleboy, add my support to the list.  Many of us have been following the various gene therapies and this one does seem to be getting a lot of attention and also as you know, you are not the first one to try it, so be comforted in not being a total Guinea Pig.  "The Team" thanks your for 'taking it' for us!
Good news about your Dr. also and thanks for starting the blog.
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline appleboy

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  • Just me!
Re: Starting VRX496
« Reply #13 on: May 01, 2007, 03:20:12 PM »
Thank you all for your support.  It really means a lot.  I sometimes don't know what I would do without all of you.
Thanks
AppleBoy ;D
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline NYCguy

  • Member
  • Posts: 180
Re: Starting VRX496
« Reply #14 on: May 01, 2007, 03:30:52 PM »
PS: I was kinda scared too when I decided to 'take one for the team' and try the vaxgen hiv vaccine a few years ago.  obviously it didn't work too well, since I'm here :) so let's cross our fingers for this one!
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline J.R.E.

  • Member
  • Posts: 7,099
  • Joined Dec-2003 Living positive, since 1985.
Re: Starting VRX496
« Reply #15 on: May 01, 2007, 07:34:06 PM »
Hello ,

Wishing you nothing , but the very best !!! I will be following your blog. I've also added it to my favorites !



Good luck to you------Ray
Current Meds ; Viramune, Epzicom, 40mg of simvastatin, 12.5mg of Hydrochlorothiazide.
Metoprolol tartrate 25mg



http://forums.poz.com/index.php?topic=40802.0

http://forums.poz.com/index.php?topic=45159.0

http://forums.poz.com/index.php?topic=39722.msg495621;topicseen#msg495621

http://forums.poz.com/index.php?topic=46806.0

http://forums.poz.com/index.php?topic=39414.msg491701#msg491701


 In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started my first  HAART regimen  on October 24th,03.

 As of 6/4/14,  t-cells are at 423, Viral load <40

 Current % is at 13% 

  
 62 years young.

Offline bobino

  • Member
  • Posts: 264
Re: Starting VRX496
« Reply #16 on: May 02, 2007, 02:32:37 AM »

Appleboy,

This is great.  You're to be commended for what you're doing.  The only way we'll ever come up with an effective treatment for this disease is if people like us volunteer for research.  I greatly appreciate the fact that you're willing to take some risks to see the science of HIV medicine advance.  All of us are indebted to you.

Many thanks and the very best wishes,

John
Suivons les rivières
Gardons les torrents
Restons en colère
Soyons vigilants

Offline krh

  • Member
  • Posts: 36
Re: Starting VRX496
« Reply #17 on: May 02, 2007, 04:23:29 PM »
I wouldn't worry about the cancer issue..  That was my original concern but it wasnt present in the first part of the study or in animals which it would have surfaced by now.  I was also in the VAXGEN trial, and obviously it didnt work for me.  But hey it was my own fault on being here.. :)

Good luck man and keep us informed.

Offline J220

  • Member
  • Posts: 587
Re: Starting VRX496
« Reply #18 on: May 02, 2007, 05:19:08 PM »
I second the comment about cancer, I have heard of no reason to worry about this with VRX496. I know that the other gene therapy trial out there, the ribozyme therapy- which works differently- did have an issue with cancer with some of the animals in the preclinical part of the the trial, but to my knowledge nothing like this has surfaced with this trial. So it sounds like this therapy is on solid ground.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline bimazek

  • Member
  • Posts: 781
Re: Starting VRX496
« Reply #19 on: May 02, 2007, 07:45:15 PM »
appleboy please please when you go in their to meet with those researchers ask them...

if this is proven to work, and we have a huge success on our hands... how will you be alble to ramp up to treating everyone in the usa ???

we have 15 to 25 people dying every day in usa from hiv

say

70% of people who die have been struggling for 20 years or more and just have too much damage no fault of their own

20% are drug users or alcoholics smokers and distroy themselves that way

10% are unlucky few who have other issues, hep C, virulent strain, weak system,

ask them how will this technology scale up to treat millions????

ask them how different will this be than just manufacturing a pill...

the machines that ...

well watch each step for example... i am not asking for secrets just

if they have to dialysis blood for 5 hours...

how will 2 million people get to do that????????????????

if they have to spend 2 hours on a lab bench inserting the dna into the vector

how will that scale up to 2 million people

we must think of this now

perhaps every clinic and every HMO can become a mini- gene therapy center

i hope this works







Offline appleboy

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  • Posts: 344
  • Just me!
Re: Starting VRX496
« Reply #20 on: May 02, 2007, 10:53:06 PM »
I have been thinking of that bimazek. How in the world if this works do they plan on producing each persons T cells?  I am sure at some point it can be automated I would guess.  My other question that has been running through my head is how they handle a mutation in the HIV.  Like when meds stop working.  I think there are lots of questions.  I will see when I go in what kinds of information I can pull from them.
AppleBoy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline bmancanfly

  • Member
  • Posts: 554
  • Medicare For All !
Re: Starting VRX496
« Reply #21 on: May 03, 2007, 08:59:45 AM »
I'm always a little miffed by the notion that a procedure that might work, and work well, but may be labor intensive to implement isn't worth persuing.  A number of the articles discussing this therpy were almost dismissive of this therpy for that reason.  Apparently, all those who are so dismissive don't have this disease - or have a loved one with this disease.  The procedure sounds to me much less time consuming than what people with diabetes have to endure.  Do we say that dialysis for diabetes is too time consuming and labor intensive?  This could succeed as a replacement for haart.  The proceed may only need to be done once a year or less.  How much time and money would that save?  What an improvement in quality of life.

Cudo's again appleboy.  If this thing works think how satisfying it will be to know you were on the front lines - making millions of peoples lives better, healthier, and longer.
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline Zanarkand

  • Member
  • Posts: 96
  • All Your Base Are Belong To Us
Re: Starting VRX496
« Reply #22 on: May 03, 2007, 02:10:17 PM »
I would like to take place as well.... Is there any way to take part or is it too late? I'm in South Africa... <sob>
* Zanarkand adds appleboy's blog to favourites
:P
All Your Base Are Belong To Us

Offline fondeveau

  • Member
  • Posts: 425
Re: Starting VRX496
« Reply #23 on: May 03, 2007, 04:10:14 PM »
So, if the HIV bug is passed on through unprotected anal sex, etc. - can Appleboy then inject (ahem...) others with his new anti-HIV bugs?

Offline appleboy

  • Member
  • Posts: 344
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Re: Starting VRX496
« Reply #24 on: May 03, 2007, 05:36:50 PM »
Fond,
I don't think that will work :-(
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline fondeveau

  • Member
  • Posts: 425
Re: Starting VRX496
« Reply #25 on: May 03, 2007, 05:39:11 PM »
Let's give it a try? (for medicinal/scientific purposes only!)

Offline appleboy

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  • Just me!
Re: Starting VRX496
« Reply #26 on: May 03, 2007, 05:54:02 PM »
Humm That is HOT!   ;D ;D ;D
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline fondeveau

  • Member
  • Posts: 425
Re: Starting VRX496
« Reply #27 on: May 04, 2007, 09:52:16 PM »
Just think how many boyz will line up for an inoculation.

Offline Zanarkand

  • Member
  • Posts: 96
  • All Your Base Are Belong To Us
Re: Starting VRX496
« Reply #28 on: May 06, 2007, 11:41:13 AM »
OMW that is the most brilliant idea ever!
I can't see why it woudn't work
w00000t!!!!!!!!!! Sleeping with someone who immunizes hiv?
LMAO!!!
Yet it would be true wouldn't it?
What would you be classed? hiv neutral?
All Your Base Are Belong To Us

Offline appleboy

  • Member
  • Posts: 344
  • Just me!
Re: Starting VRX496
« Reply #29 on: May 06, 2007, 02:09:55 PM »
I really wished it worked that way and if it did I would need a take a number and revolving door.  Might need to loose a little weight too!
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline Zanarkand

  • Member
  • Posts: 96
  • All Your Base Are Belong To Us
Re: Starting VRX496
« Reply #30 on: May 06, 2007, 02:42:37 PM »
hmm... why wouldn't it work??
All Your Base Are Belong To Us

Offline frenchpat

  • Member
  • Posts: 516
  • Love your friends, don't eat them.
Re: Starting VRX496
« Reply #31 on: May 06, 2007, 02:44:40 PM »
AppleBoy (sounds a bit like a superhero name non?),

I only just stumbled on this thread and I belatedly thank you for doing this. I think it is very courageous. Thank You.

It is perhaps not entirely by chance that I recently came across an article in the French press about the "outsourcing" of drug trials by the pharmaceutical industry and the implications, ethical and real, that come with it. If interested you can start with http://www.soniashah.com/index.php.

In the light of this information, of the recent events in Thailand and Brazil, it seems obvious to me that one of the solution to these problems is for us westerners to get more involved.
I was very ignorant of such issues until recently and like most people, would be afraid to participate in a trial. Yet yours is an example to follow and not only will I read your blog but I will give serious consideration to what my options are here in France in terms of getting more involved with research.
It hurts me everytime I read on these forums about a twenty-something who's hiv+, because, as unlucky as I may be to be positive myself, I am nearing 50 and in reasonably good health. I feel I ought to do more so that someone else, infected at a young age anywhere in the world, might get a better chance to reach that same age.

Thank you for having the courage to do this, thank you for being an inspiration.

Pat
People have the power - Patti Smith

Offline appleboy

  • Member
  • Posts: 344
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Re: Starting VRX496
« Reply #32 on: May 06, 2007, 04:25:26 PM »
French,
Thank you!  I don't think I am doing anything special.  I honestly just feel in my heart to do it no matter what may come of it.  I will be checking out your link you posted.  I always tell people follow your heart and if doing a trial is what your heart says then I say by all means follow it. 
AppleBoy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline fondeveau

  • Member
  • Posts: 425
Re: Starting VRX496
« Reply #33 on: May 07, 2007, 12:45:30 PM »
hmm... why wouldn't it work??

From the illustration, it seems that you are putting this new dna into a CD4 cell.  The subjects CD4 cell - presumptively, even if you were exposed to someone else's CD4  cells, your immune system would attack the foreign object?

Offline appleboy

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  • Posts: 344
  • Just me!
Re: Starting VRX496
« Reply #34 on: May 07, 2007, 09:26:12 PM »
My understanding is that when the HIV hits one of theses VRX496 cells it then stops the HIV from replicating.  From what I have seen on the company's website I think this happens after the RNA is converted to DNA and then bonded to the CD 4's DNA then starts to make the new HIV RNA.  Once it sees that RNA it starts working to keep the RNA from budding out of the CD 4 cell and making more HIV.  Whew that was a finger full!  I hope that makes sense.
AppleBoy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline FiercenBed

  • Member
  • Posts: 183
Re: Starting VRX496
« Reply #35 on: May 08, 2007, 06:33:46 PM »
mmm...im a little perplexed. i interviewed for the trial in new york in march. i was told this was phase IIb trials and ur viral load had to be >5,000 to qualify.  phase III <50 viral load was gonna be done in november. i get the impression there under a lota competition with other trials which is refreshing. the doc who was in charge of the program was in s africa. i was @ 3,000 vl and climbing. anyway...i was blocked because of previous ks. my doc talked to trial doc and he said it was "rocket science"...lol; but my doc can be a dumb ass. i thought what we need round here is a little more rocket sceince and a little less pills! my thoughts r if they get this right no one but 'the rich folk' r gonna b able to afford it <like lasic eye surgery>. bet blue cross & blue shield ain't gonna cover it. so get it while u can.....good luck:)

ps: that ass testing thing made me uneasy 2....i mean my ass is what got me in trouble in the first place....lol....not to mention they wanted ur dead body for autopsy....yikes

ps2: i dont know if ya mentioned above but the big fricken deal is ....NO SIDE EFFECTS!!!!!.....can u imagine?
« Last Edit: May 08, 2007, 09:12:25 PM by FiercenBed »

Offline appleboy

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  • Posts: 344
  • Just me!
Re: Starting VRX496
« Reply #36 on: May 08, 2007, 07:04:57 PM »
Fierce,
Yes I am pretty sure this is going to be a rather expensive thing.  Now if it does what they think it does the price may come down.  Now let me throw this out lets say that it keeps you off meds for 3 years at time the cost of my current medication Atripla is 1,526.99 a month (that is with no insurance).  3 years of Atripla is 54,971.64 lets choose a number that doing this would cost 20K a pop.  That would actually come out to be a huge savings.  Granted all the numbers are just guesses and it if actually works.  Yes the anal biopsies don't thrill me at all hence why I came up with taking one for the team.  I want to make a t-shirt that says that an wear it when I have to have those done.  The autopsy does not bother me.  I cannot donate blood or organs so why not let them do something with me when I leave this earth at least I don't feel like my body will just go to waste. 
Laterz
AppleBoy
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
My Blog

Offline Jake72

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  • Posts: 145
Re: Starting VRX496
« Reply #37 on: May 08, 2007, 08:23:45 PM »
phase III <50 viral load was gonna be done in november.

Phase III in November?  Any websites mentioning this?  I've gone to the Virxsys website, and while it does mention several different trials for people who are on and off HAART, there's no mention of phase III. 

You've gotta take pics of the t-shirt (once you get it) for your blog, Appleboy!


Offline FiercenBed

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  • Posts: 183
Re: Starting VRX496
« Reply #38 on: May 08, 2007, 09:26:58 PM »
mmm...iv got the trial pack round here some where. pretty sure about the phase III thing. they had a whole article on here  or in poz for the trial. i think it was titled "smells like almonds." cause the dude said that during the procedure he smelled almonds. go figure.

one of the big problems was it didn't penetrate the blood brain barrier. that ole blood brain barrier thing. lota good questions above. look @ it this way they havnt killed any1....lol so go for it! if ya get the answer b sure to let us know.

like u said apple the numbers sure do work....but will mr evil big pharma let it happen.  ill bet a dollar @ the race track is that if it works abbott or lilly will buy it lock stock & barrell. but ya gota start somewhere.....like i said above.....good luck ;)

 
« Last Edit: May 09, 2007, 06:37:14 AM by FiercenBed »

Offline Jake72

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  • Posts: 145
Re: Starting VRX496
« Reply #39 on: May 08, 2007, 09:42:46 PM »
Thanks, Fierce!  Here's the Poz article that you mentioned:

http://www.poz.com/articles/401_10904.shtml


Offline appleboy

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Re: Starting VRX496
« Reply #40 on: May 08, 2007, 10:54:00 PM »
Thanks Jake for finding that article.  I never thought to toss it in here.  I guess once I get all the way in and start this we may find out more.  I will be keeping everyone up on what is going on.
AppleBoy
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Offline redhotmuslbear

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Re: Starting VRX496
« Reply #41 on: May 15, 2007, 12:33:02 PM »
AppleBoy,
I just learned of this thread from a posting by a mutual bud on a listserv.  You go, boy!  Personally, I had no second thoughts about doing a trial for an off-label use of a drug, but letting someone tweak my immune system would be outside my comfort zone.

Cheers,
David near DC

P.S.  If you really want to take one for the team, I've got a nice wet one for ya  ;)  Our children might be like little Micah on "Heroes"--with my aggressive CD8s and your jacked-up CD4s, our kids could save the world!
"The real problem is not whether machines think but whether men do." - BF Skinner
12-31-09   222wks VL  2430 CD4 690 (37%)
09-30-09   208wks VL  2050  CD4 925 (42%)
06-25-08   143wks VL  1359  CD4 668 (32%)  CD8 885
02-11-08   123wks off meds:  VL 1364 CD4 892(40%/0.99 ratio)
10-19-07   112wks off meds:   VL 292  CD4 857(37%/0.85 ratio)

One copy of delta-32 for f*****d up CCR5 receptors, and an HLA B44+ allele for "CD8-mediated immunity"... beteer than winning Powerball, almost!

Offline appleboy

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Re: Starting VRX496
« Reply #42 on: May 15, 2007, 02:15:23 PM »
HAWT!   ;D
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Offline hahaha

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Re: Starting VRX496
« Reply #43 on: May 20, 2007, 10:23:43 AM »
Dear Appleboys.

Send my best wishes here. and I also wish I can attend such trial.  Too bad I am a Taiwanese and may possibly not be qualified.
Basically, I wont' worry about cancer and all that stuff, because, HIV has already did the insertion!!, the VRX is only insert a similar but cure one, so if there is any harm, HIV shall harm first.

The iRNA is very advance.  I think that is the best at this moment the scientist can do to us.  I hope i can do it someday, too.



Aug 9, 2006 Get infected in Japan #$%^*
Oct 2006 CD4 239
Nov 2006 CD4 299 VL 60,000
Dec 1, Sustiva, Ziagan and 3TC
Jan 07, CD4 400

Offline appleboy

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Re: Starting VRX496
« Reply #44 on: May 21, 2007, 02:55:41 PM »
Thank you HAHAHA.  Today I talked to folks down at VIRxSYS today to try and get some answers to some of the questions that have been brought up in this thread.  The guy I talked to was awesome and when I get home and can look at the questions I asked I will post more of what I found out.  I think it is wonderful these folks are open and talking.
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Offline appleboy

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Re: Starting VRX496
« Reply #45 on: May 21, 2007, 05:32:20 PM »
So today I talked to someone at VIRxSYS on the phone and presented them with some questions.  Most of the questions are hard because this is still a study but this what I got.
1. If this is proven to work (I know this is a trial and there a lot of unknowns) how will Virxsys ramp up to make this treatment available to masses? This can be done by using dialysis centers for collecting the t-cells.

2. The process as of now requires apheresis (This almost looks similar to dialysis) if this works is this going to require each person to have to have this procedure?  Could the process of altering the T cells be automated? This is very much automated by machine with no human touching of the cells.  Humans do watch the process.

3. How does VRX496 handle a mutation in HIV ie you are on Atripla and Atripla stops working because the HIV mutated? Did not get an answer to this question

4. If this works and is approved what kind of price tag are we talking about and how does it compare to a medication regimen (referring the current list of approved medications)? Did not get an answer to this question

I did ask how they knew how much Anti-Sense to add and again this is part of the study that they are looking into. They are testing the amounts of Anti-Sensed cells.  Each testing center is doing different studies on this.  So I asked if anyone on the study so far was off medications and right now there is one person and so far they have not had to go on medications.  So I would say this is still looking rather promising.  I hope this answers some of your questions that are burning away in the backs of your minds.
AppleBoy
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Offline bimazek

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Re: Starting VRX496
« Reply #46 on: May 22, 2007, 01:04:29 AM »
appleboy you are a god thank you so much for doing this for all of us and asking the questions great info.
seems clear and honest, the dialysis centers can ramp up to meet the need

regarding the atripla question... i would not worry about mutated virus with this gene therapy, because take a look at the animations i posted on another thread, search my username and animation as key word
the virus seems so malicious in the mutation but when you see physically how tiny the difference is and how unimportant the change is you will see (from the virxsys animation) that the method would still be very effective

this was one of the great advances in science called Quantum Mechanics and Dynamics --  basically, really complex things like chemical reactions and molecules and all biology is just very simple  Mechanics -  Mechanical issues, like building a bridge or putting a thread thru a needle or putting a car back together from parts,... the math and movement is totally the issue,  in biology it is only on a tiny tiney scale, but still mechanical ...

for example the virus mutates so protease does not work... what does that mean, very simple, think of the virus as a 3D object, the protease is another 3D object, the mutation simply means that one arm of the virus is a tiny bit different or bent or longer, so the  protease inhibitor which is just another 3D object, but the shape of the protease inhibitor stops the virus from working or doing its thing, well

that difference is shape is tiny tiny but it stops the protease from working but the virus itself is 99.999999% the same.

so then you bring in big guns of gene therapy and actually cutting up the DNA of virus at certain points.. well the body is designed to do things at this small scale so if they create a sissors to cut the viral dna up (which the body does all the time anyway, they are just creating a specific sissor for hiv rna or dna)

the scale of the mutation is extra tiny 1000 times smaller than the sissors

so it is about scale and mechanical shapes and sizes

check out the animations on all three websites

virxsys
http://forums.poz.com/index.php?topic=7476.0
and these

This is an amazing video

http://www.youtube.com/watch?v=RUUyd5bE9vQ&mode=related&search=
viramune animation



protease animation
http://www.youtube.com/watch?v=VoMGqPqnyDQ&mode=related&search=



resistance
http://www.youtube.com/watch?v=TvNOmwRh0I0


http://www.youtube.com/watch?v=RO8MP3wMvqg&mode=related&search=


in the end it is a kind of rock sissors paper thing...

and i would not worry about the drug companies buying it

there would be too many millions of people upset

what i am worried about is the 15 to 30 guys who are dying daily who would have to wait

1. between the time it was approved and the ramp up process got done and ready to take lots of people
2.  when the hmo's and dr.s got feeling safe with it enough to Rx it

that is why i think we need a special activism and meeting around just these two issues 1 and 2

we need a fund by congress to fund the fast roll out...

see my post in activism

peter stanley are you listening you are the stud man in this, we need guys like you with elite connections to

advocate for a

cancer, hiv, breast cancer breakthru ramp up roll out fund to get it to as many as possible if and when the day comes that

.....

Offline appleboy

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Re: Starting VRX496
« Reply #47 on: May 22, 2007, 06:25:23 AM »
Thanks Bim for the great videos.  I think the ramp up period will still take time.  Here is what we as patients have to do and that is request the therapy if it is indeed approved and works.  Then take on the insurance companies if they want to fight it.  Now if the FDA approves it I would think most insurance carriers would cover it though this step may take a little bit of time.
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Offline appleboy

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Re: Starting VRX496
« Reply #48 on: May 23, 2007, 09:33:51 PM »
Just found this on UPenn's website:

Fighting HIV With HIV: New Gene Therapy Vector Shows Promise in Penn HIV Study
        
(Philadelphia, PA) - Researchers at the University of Pennsylvania School of Medicine report the first clinical test of a new gene therapy based on a disabled AIDS virus carrying genetic material that inhibits HIV replication. For the first application of the new vector five subjects with chronic HIV infection who had failed to respond to at least two antiretroviral regimens were given a single infusion of their own immune cells that had been genetically modified for HIV resistance.

The researchers, led by Carl June, MD, and Bruce Levine, PhD, of the Abramson Family Cancer Research Institute and the Department of Pathology and Laboratory Medicine, along with Rob Roy MacGregor, MD, Professor of Medicine, report their findings in the online edition of the Proceedings of the National Academy of Sciences. Viral loads of the patients remained stable or decreased during the study, and one subject showed a sustained decrease in viral load. T-cell counts remained steady or increased in four patients during the nine-month trial. Additionally, in four patients, immune function specific to HIV improved.

Overall, the study results are significant, say the researchers, because it is the first demonstration of safety in humans for a lentiviral vector (of which HIV is an example) for any disease. Additionally, the vector, called VRX496, produced encouraging results in some patients where other treatments have failed.

“The goal of this phase I trial was safety and feasibility and the results established that,” says June. “But the results also hint at something much more.”

Each patient received one infusion of his or her own gene-modified T cells. The target dose was 10 billion cells, which is about 2 to 10 percent of the number of T cells in an average person. The T-cell count was unchanged early after the infusions. “We were able to detect the gene-modified cells for months, and in one or two patients, a year or more later,” says Levine. “That’s significant – showing that these cells just don’t die inside the patient. The really interesting part of the study came when we saw a significant decrease in viral load in two patients, and in one patient, a very dramatic decrease.

But, cautions Levine, “just because this has produced encouraging results in one or two patients doesn’t mean it will work for everyone. We have much more work to do.” In the current study, each patient will be followed for 15 years.

Trojan Horses
“The new vector is a lab-modified HIV that has been disabled to allow it to function as a Trojan horse, carrying a gene that prevents new infectious HIV from being produced,” says Levine. “Essentially, the vector puts a wrench in the HIV replication process.” Instead of chemical- or protein-based HIV replication blockers, this approach is genetic and uses a disabled AIDS virus to carry an anti-HIV genetic payload. The modified AIDS virus is added to immune cells that have been removed from the patients’ blood by apheresis, purified, genetically modified, and expanded by a process June and Levine developed. The modified immune cells are then returned to the patients’ body by simple intravenous infusion.

This approach enables patients’ own T cells, which are targets for HIV, to inhibit HIV replication – via the HIV vector and its anti-viral cargo. The HIV vector delivers an antisense RNA molecule that is the mirror image of an HIV gene called envelope to the T cells. When the modified T cells are given back to the patient, the antisense gene is permanently integrated into the cellular DNA. When the virus starts to replicate inside the host cell, the antisense gene prevents translation of the full-length HIV envelope gene, thereby shutting down HIV replication by preventing it from making essential building blocks for progeny virus. VRX496 was designed and produced by the Gaithersburg, Md. biotech company VIRxSYS Corp.

A New Field
The new vector is based on a lentivirus, a subgroup of the well-known retroviruses. The study and its safety profile to date have now opened up the field of lentiviral vectors, which have potential advantages over other viral vectors currently being studied because they infect T cells better than adenoviruses, a commonly used viral vector. Lentiviruses also infect non-dividing or slowly dividing cells, which improves delivery to cells such as neurons or stem cells, thus enabling the evaluation of gene therapy in an even wider array of diseases than before. Furthermore, lentiviral vectors insert into cellular DNA in such a way that may be safer than other gene therapy vectors. This is because lentiviruses appear to insert differently from other retroviruses that have caused side effects in other trials involving stem-cell therapy. In addition, gene insertion by lentiviral vectors is attractive for potential therapeutics since it enables long-term gene expression, unlike other viral vectors where expression is lost over time.

Penn researchers are now recruiting for a second trial using the VRX496 vector with HIV patients whose virus is well controlled by existing anti-retroviral drugs, a group of patients who are generally healthier and have more treatment options available. This trial will use six infusions rather than one and is designed to evaluate the safety of multiple infusions and to test the effect of infusions on the patients’ ability to control HIV after removal of their anti-retroviral drugs. The hope is that this treatment approach may ultimately allow patients to stay off antiretroviral drugs for an extensive period, which are known to have significant toxicity, especially after long-term use.

The research was supported by the National Institute of Allergy and Infectious Disease; the Abramson Family Cancer Research Institute; and VIRxSYS Corp. In addition to June, Levine, and MacGregor, co-authors on the paper are: Jean Boyer and Frederic Bushman from Penn; Laurent M. Humeau, Tessio Rebello, Xiaobin Lu (now with US Pharmacopeia), Gwendolyn K. Binder (now with Penn), Vladimir Slepushkin, Frank Lemiale, and Boro Dropulic (now with Lentigen Corp, Baltmore) from VIRxSYS; and John R. Mascola from the National Institutes of Health.
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Offline Jake72

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Re: Starting VRX496
« Reply #49 on: May 23, 2007, 10:13:25 PM »

But, cautions Levine, “just because this has produced encouraging results in one or two patients doesn’t mean it will work for everyone. We have much more work to do.” In the current study, each patient will be followed for 15 years.

Good God, the results from this phase won't be available for at least 15 years!!?? 

 


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