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Author Topic: Starting VRX496  (Read 48150 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: 605
  • 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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  • Posts: 344
  • 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: 7,277
  • 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, 25 mg 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


Diagnosed positive in 1985,.. In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started on  HAART on October 24th, 2003.

 As of 8/25/14,  t-cells are at 402, Viral load <40

 Current % is at 11%

  
 63 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

  • Member
  • 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: 605
  • 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

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  • Posts: 344
  • Just me!
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
  • Just me!
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

  • Member
  • 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

  • Member
  • 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!!?? 

Offline appleboy

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Re: Starting VRX496
« Reply #50 on: May 24, 2007, 06:09:58 AM »
I don't know that the whole study will be followed for 15 years.  I do know that each person in the study will be followed for 15 years.  Does that mean the study if approved will take 15 years?  Not sure but I would sure hope not. 
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Offline bimazek

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Re: Starting VRX496
« Reply #51 on: May 24, 2007, 11:21:48 PM »
there is billions of revenue and millions to anyone who discovers something like this, the 15 years is just protocol to show how compassionate and careful they are being with test subjects.  If it worked like gang busters it would be put on market much like many things are, and if some have side effects they would look into that then...
the 15 years is just so they do their job, this is very new new science and they must follow the law,

if it works i see many people who are failing other drugs to be put on this, Dr. do not want to have someone die if there is something that will keep them alive so seems like the first would be, failing other combos

so that is in a way good because they can go thru compassionate use, which has fewer restricitions

also i want to state emphatically

gene therapy will triumph over all viral resistance for the reasons i outline above

if you carefully watch the animations and understand

you will see what i mean

the sissors that cut things up inside cells are very efficient, think how good skin grows and falls off, and this gene therapy is kind of like giving the nucleus a message to ... hey cut up this dna that isnt suppose to be in here...

hope


Offline bimazek

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Re: Starting VRX496
« Reply #52 on: May 25, 2007, 01:51:48 PM »
Jun 1 2007 (Vol. 27, No. 11)
VIRxSYS  VRX496 Preclinical studies show that HIV is unable to mutate around VRX496.

Some patients maintained outcomes for three years, and genetically modified CD4 T cells remain in circulation.

-convenient for patients by eliminating the need for multiple daily pills.

Jun 1 2007 (Vol. 27, No. 11)

http://www.genengnews.com/articles/chitem.aspx?aid=2119
VRX496 suppressed viral loads and restored the immune system responses in chronic HIV patients. This is an important milestone in the development of what we believe could be the next generation of HIV therapy, says Riku Rautsola, Ph.D., president and CEO of VIRxSYS.

VRX496 is the first and only lentiviral vector therapy approved by the FDA for clinical trials. The backbone of VRX496 consists of a genetically engineered version of HIV in which all the infectious components are removed and replaced with the therapeutic payload a long antisense sequence that targets the HIV envelope protein and cripples the virus.

Preclinical studies show that HIV is unable to mutate around VRX496. which should prevent the formation of resistant strains. We have seen no resistance develop to our therapy in vivo or in vitro.

VRX496 is an autologous therapy that uses a patient’s own cells.

The goal is to repopulate a patient’s immune system with genetically engineered cells that promote immunity against HIV and prevent the progression to AIDS. Although not a cure, VRX496 could improve the quality of life for HIV patients by bringing viral loads down to low levels.

In a Phase I trial, five chronic HIV patients, who had failed to respond to multiple standard antiretroviral drug regimens, received one infusion of VRX496. All patients showed stable or decreased viral loads as well as stable or increased immune responses to HIV antigens. Four of the five had stable or increased CD4 T cells. Some patients have maintained these positive outcomes for up to three years, and the genetically modified CD4 T cells remain in circulation.

A Phase II study is under way in 40 chronic HIV patients to further establish the safety and tolerability of VRX496 and to determine the optimal dose.

Current anti-HIV drugs are small molecules that are highly toxic. Because HIV mutates rapidly, it often becomes resistant to conventional drug regimens taken by patients. VIRxSYS’ alternative gene therapy is designed to block all the mutation sites on HIV, preventing resistance. Thus VIRxSYS says that VRX496 overcomes the problems of toxicity and resistance.

VRX496, which is intended as a short-term therapy that offers long-term benefits, may be more convenient for patients by eliminating the need for multiple daily pills.

privately held VIRxSYS has a unique financing model. A group of private shareholders provides funds, and the company has not had to rely on traditional venture capital. “We are fortunate to have loyal shareholders who finance us,” Dr. Rautsola says.
http://www.genengnews.com/articles/chitem.aspx?aid=2119  read the full article it is great...
Jun 1 2007 (Vol. 27, No. 11)





Offline NYCguy

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Re: Starting VRX496
« Reply #53 on: May 25, 2007, 04:16:51 PM »
In a Phase I trial, five chronic HIV patients, who had failed to respond to multiple standard antiretroviral drug regimens, received one infusion of VRX496. All patients showed stable or decreased viral loads as well as stable or increased immune responses to HIV antigens. Four of the five had stable or increased CD4 T cells. Some patients have maintained these positive outcomes for up to three years, and the genetically modified CD4 T cells remain in circulation.

Thanks Biz for the great info and thanks again Appleboy for doing this - we are ALL grateful. 

I remember reading a pretty extensive discussion in the old forums where the 5th guy of the 'four of five' mentioned above was posting a lot and was pretty pissed about some of the ways he had been treated and also that it looked like he wouldn't be allowed to be in future studies, which seemed pretty insane.  Again, I can't find the link, so if anyone knows how to get to those forums, it might be interesting and helpful to read up on it and maybe contact him too - especially for Appleboy. 

I'm also still dying to know the outcome of the Johnson/Tibotec gene therapy trial that was supposed to be finished in Jan.  From the article in the SF chronicle, that one sounded extremely promising, yet there has been no mention of it anywhere of late - at least that I've seen.

Thanks again Apple - we're following your every post with bated breath!
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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Re: Starting VRX496
« Reply #54 on: May 25, 2007, 04:37:51 PM »
Bim,
You are such a sweetie!  Thanks for all your information.  NYC thanks for support it is much appreciated.  The first meeting for the trial is coming up soon.  I think I am kinda excited but kinda nervous at the same time.  The whole anal biopsies have me in a bit of a tizzy.  I don't like being naked in an office around strangers having things stuck up my butt.  If I can get past the way I feel about that I think I will be ok. 
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Offline fondeveau

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Re: Starting VRX496
« Reply #55 on: May 26, 2007, 07:55:20 PM »
I don't like being naked in an office around strangers having things stuck up my butt. 

Ummm..how DID you manage to get infected?

Offline appleboy

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Re: Starting VRX496
« Reply #56 on: May 26, 2007, 10:26:34 PM »
Immaculant Infection  ;D
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Offline bimazek

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Re: Starting VRX496
« Reply #57 on: May 27, 2007, 12:08:43 AM »
i am thinking about this and i am going to do a first draft here, although anyone who reads my posts knows they are all first drafts un-corrected or spell checked... ohh i just noticed the spell check button on here for first time ever, well that is i guess what it means being only a few months after diag.

here is my thoughts

how do you get a giant ocean liner cruise ship to stop

how do you get a giant ocean liner cruise ship to stop and go in opposite direction

it takes so so much time, well this is how i feel we are all, in a ship

the ship is haart, and meds, and toxic meds, and side effects, the Dr.s are driving or the insurance companies or a combo of many powerful groups

remember when all there was was azt, well a few crazy dr.s started giving guys multiple meds and some guys even shared and had parties where they would all take each others meds, i think they put them in a bowl

i am not advocating any of that, and i am totally pro haart under 350 and i am sure treatment interuptions must only be done in certain circumstances so i am not against haart

anyway remember that period between 1990 and 1996 and really even 1998 when haart was widely accepted and given to most in usa, and then it took time to figure out why some were not responding perfectly, most did great

well

that period in the 1993 to 1998 is kind of like now

i would like to boldly say, i believe that the virsys VRX496 is so dramatic in its results and so powerful and as the article that thier scientists wrote the meds are toxic, well i have never yet been on meds and i am holding on to every t cell, trying to go as far into future before starting meds but i will start when necessary

anyway

the virsys VRX496 is so dramatic in its results adn so hopeful and such, even though the first trial is small, lets say it is 12 or 22 months and the group of guys and appleboy and such tell us how great they are doing

how long how hard will it be how long will it take to slow this giant cruise ship of haart and meds, and Rx and pills, how long will it take until dr.s are comfortable until fda approves until compassionate use kicks in

i mean lets do a million man march from washington TO PHILLY that would be dramatic or at least all drive there

i dont know perhaps i am talking out of fear but really i cannot accept one more day of hiv poz guys dying, i have been watching this channel of suffering for 25 years as many have, i was neg. 2 years ago... i have lost so so many friends lovers, mentors, etc...  and

well it seems so close it seems so hopeful

i mean the article the way it said     June 1, 2007    while its still in may, i know mags do that , but it seemed almost like it was coming out of the future

we need to meet with congressmen now

barney frank -- can someone call him or email him this info

about  virsys VRX496

ok lets do a thought experiment,

day one -- what does it take to get compassionate use approved for a GENE THERAPY -- see that is something that has never been done before!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

to ramp up the treatment of a gene therapy -- that has never been done before!!!

is there any gene therapy that is currently fda approved?

does it take a different path than drug approval?

this has never been done before...

the time lag, of the 15 to 25 people who die every day in USA from HIV and its related diseases and causes

what do we need to do to get an expanded 3rd phase trial

after compassionate use is approved how long does it take to get to next step

is there something availble

i mean ... what does it take to give this  virsys VRX496 -- as compassionate use to many people

keep taking haart though cause that is important and even vrx496 can come later

what are your answers to these questions...


Offline fondeveau

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Re: Starting VRX496
« Reply #58 on: May 27, 2007, 03:04:44 AM »
Immaculant Infection  ;D

So, we need to spend less time worrying about what goes into your butt and be prepared to worship what comes out of it.  Ew!

Offline hahaha

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Re: Starting VRX496
« Reply #59 on: May 27, 2007, 04:11:54 PM »
Dear Appleboy:

While they check on your CD4, will they also check your PD-1 or other index that people believe is also related to AIDS progressing?
If not, would you mind requesting for that data?

Correct me if I am wrong, but I believe you are on Haart now.  What was your lowest CD4 before? and When was it? And your Haart combination is?

 Sorry for intriguing question like this.  Since some paper said CD4 is not the only index that shows the result. I believe other index like PD-1 is also very important.   
And the medicine you take may have some effect on "penetration rate" of VRX496.  Therefore, I would appreciate the disclosure.


Thanks a lot.







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 #60 on: May 27, 2007, 10:45:50 PM »
My lowest count was almost a year ago at 165 and I am on Atripla.  So I am not sure what is a PD-1 could you tell me what that is?
Thanks
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Offline bimazek

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Re: Starting VRX496
« Reply #61 on: May 30, 2007, 07:16:07 PM »
PD-1 levels are only measured so far in animal and human clinical trials it is not available yet to doctors, in clinical practice, only in Universities and Studies, it parallels almost exactly the CD4 count numbers but recent discoveries in last few weeks, show that it actually may PREDICT the rapid fall of CD4s, and come first and be actually the cause of the rapid fall of CD4s.  for example, the CD8 cell has pd-1 receptor, when the pd-1 is low and not turned on the CD8 does just fine and fights off hiv every day, this goes on for years, then some trigger or chemical causes the pd-1 switch (there are millions on every CD8) to be turned on to high.

 pd-1 high HIV specific CD8 cell is what it is called

when these switches get turned on then the CD8 becomes disfunctional and disoriented and does not work well fighting off and suppressing the hiv virus, which it had done so well for the first 5 to 19 years of the disease of hiv.

when this happens, and science in last weeks feel it is preceeds the fall in cd4 obviously because once the cd8 stop fighting the hiv off the cd4s are cascading and more and more get infected

so once the cd8 is not supressing the infection that is when the cd4s drop from say 300 to 200 to 100 to 30, and this sometimes can happen quickly

one week ago they discovered that, it is the number of  pd-1 switches that are turned on or high in the  HIV specific CD8 cell that determines if the cd8 becomes unable to fight, in other words if 90% of the pd-1 on outside of one cd8 cell are still low, then the cd8 works just fine, but if, say 80% are high then the cd8 doesnt work.

also 2 months ago chinese at univ beijing proved that all LTNP all long term non progressors have a pd-1 that is different, and somehow stays low, so the cd8s never get turned off,

now they are working on why and how and how much etc.

http://forums.poz.com/index.php?topic=7475.0

check my post on this subject in january...


Offline appleboy

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Re: Starting VRX496
« Reply #62 on: May 30, 2007, 09:15:38 PM »
Thank you Bim sweetie!  :-*
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline SASA39

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Re: Starting VRX496
« Reply #63 on: May 31, 2007, 02:48:13 AM »
PD-1 is not a 'switch" although one may call it so.............
PD stand for Programmed Death   , and it is a type one ( 1 ) neuroreceptor with specific role of surviving CD8 cells in case of HIV infection.
http://www.jem.org/cgi/content/abstract/203/10/2281
http://www.nature.com/nm/journal/v12/n10/abs/nm1482.html 

edited for adding a link more , and a salute to appleboy
                                       Al
« Last Edit: May 31, 2007, 02:55:45 AM by SASA39 »
Oct.     `06.  CD4=58  ?    %       VL not perform. ?!?
25.Dec.`06.         203       14        VL= 0
29.May.`07.    broken device        VL=1363
20.June`07     broken device        VL=0
25.Dec `07  CD4=582                  VL=70
14.May `08  CD4=448
29.July `08                                  VL=0
26.Nov `08  CD4=674                    VL=179
16.Mar `09  CD4=554                    VL=0
19.Jan`10 CD4=715               
03.Mar`10                                    VL=0
24.Aug`10 CD4=524                     VL=0
04.Dec`10 CD4=626                     VL=0
15.Sep`11                                   VL=93
17.Nov`11                                   VL=0
05/26 .Jul`12 CD4=713                 VL=0
28.Nov`12 CD4=916                     VL=0
09.May`13                                 VL=0

Offline SASA39

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Re: Starting VRX496
« Reply #64 on: May 31, 2007, 03:48:18 PM »
Yes some indeed call that receptor switch ........
"HIV 'switches off' immune cells "
http://news.bbc.co.uk/2/hi/health/5263190.stm
                   Al
Oct.     `06.  CD4=58  ?    %       VL not perform. ?!?
25.Dec.`06.         203       14        VL= 0
29.May.`07.    broken device        VL=1363
20.June`07     broken device        VL=0
25.Dec `07  CD4=582                  VL=70
14.May `08  CD4=448
29.July `08                                  VL=0
26.Nov `08  CD4=674                    VL=179
16.Mar `09  CD4=554                    VL=0
19.Jan`10 CD4=715               
03.Mar`10                                    VL=0
24.Aug`10 CD4=524                     VL=0
04.Dec`10 CD4=626                     VL=0
15.Sep`11                                   VL=93
17.Nov`11                                   VL=0
05/26 .Jul`12 CD4=713                 VL=0
28.Nov`12 CD4=916                     VL=0
09.May`13                                 VL=0

Offline appleboy

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Re: Starting VRX496
« Reply #65 on: May 31, 2007, 04:55:08 PM »
Interesting stuff SASA.  Thank you!  :-*
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Offline bimazek

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Re: Starting VRX496
« Reply #66 on: May 31, 2007, 05:07:40 PM »
PD-1 is best not to be called Programmed Death anymore, because that was a Mis-naming that was done at the time of discovery of pd-1 ten years ago or 12 i forget, it is bad idea and science is calling it other things now because when they first isolated and noticed the receptor it was on cells that were under-going a natural process called cell apotosis or cell death or cell go by by, many times when cells are not used anymore the body sends a signal to the cell to get rid of itself so new cells can take over
when they discovered  PD-1 they called it  Programmed Death-1 because when a cell was dying they noticed that there was this chemical switch and they made the mistake of thinking this switch causes the cell death, it does not it was present because

before the cell dies the body turns off the functioning of the cell first -- and now they discovered that that is what the receptor or switch does it tells the cell to stop functioning to become exhausted

so dont be frightened by the name

it was a mis-naming because they thought it was involved but now they know
esp. for hiv disease, that the pd-1 controls a path that tells the CD8 cell

hey you are done with fighting this viral infection, go to sleep or become exhausted or become un functioning

remember when you get a cold or a flu the body stages a big immune response and you can feel it as a wave of attack of the immune system as it kills the bugs, then you feel the immune system backing off and cleaning up and checking things to see if the infection is gone then sometimes if the body thinks that the infection is still there it attacks again sends soldiers out and then retreats and puts the soldiers away and cleans up all the toxins that are released by the fight

this is what pd-1 is for, it is part of signalling to tell the cd8 killer cells, hey things are taken care of, go away not needed anymore, the problem with hiv disease is

it is a trick the infection is hiding inside the very cells that are part of the immune system so the immune system managers get all confused and eventually they stop fighting the hiv

remember our bodies do a great job for 5-11 years and some times 20 years without meds, the cd8s are doing the fight 50 billion viruses a day and killing them and sweeping up the mess that is made in the war

so

then as i wrote above

so the real name could be Programmed Exhaustion or Programmed disfunction

and that is also what is so cool about a new discovery about pd-1 in nov or dec 2006

that if they block the pd-1

THE CD8 CELLS are NOT DEAD OR PERMANTENTLY turned off, all they have to do is block the PD-1 and the CD8 wakes up and is fully fuctional and can fight HIV and the infection just like the first 3-9 years of the infection

this was just discovered i think dec 2006

a big breakthru becuase they didnt know if the cd8 SYSTEM was so messed up by the pd-1 that it wouldnt work in the future at all and no treatment could repair it

and they found wow, the cd8s are there in numbers they function and they can come back strong as before

this is how apes cats etc fight thier HIV they never get sick cause the body cd8 never get exhausted

without meds

but i am most excited about the VRX496

this is fighting

FIRE WITH FIRE

fighting the HIV with a modified hiv that has some gene sizzors inserted into it

then when hiv starts replicating the gene sizzors start replicating

and

cut up all the bad new hiv dna


Offline Jake72

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Re: Starting VRX496
« Reply #67 on: May 31, 2007, 09:30:51 PM »
Hey folks,

Here's an older (2005) story about VRX496.  What's interesting is that it gives a sort of preliminary timeline leading towards approval (if everything goes as planned, which is, granted, a big 'if').  Anyway, they appear to be a little bit behind schedule, although someone posted here that Phase III was a possibility for this year.  In any event, this is what it says:

'But Rautsola also said the company is continually looking for a partner, and he expects VIRxSYS to team with another company before beginning Phase 3 trials by 2007. He said if all goes well, Phase 3 trials could be completed in early 2009, and a product could go on the market later that year, adding that if the FDA approves an accelerated regulatory path the product could get to large patient populations before that.'

http://english.hiv.com.vn/medicine/default/0510357843.aspx

Let's hope, huh?

Offline appleboy

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Re: Starting VRX496
« Reply #68 on: May 31, 2007, 10:14:49 PM »
For those looking for the results of the first (safety) trial of VRX496 I found it.  http://www.pnas.org/cgi/content/full/103/46/17372 .  It is quite an eyeful to read but it really gives some ideas of how the subjects did.
Enjoy!
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Offline bimazek

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Re: Starting VRX496
« Reply #69 on: June 09, 2007, 04:40:17 AM »
appleboy do you get to meet other guys who are in the trial, do you talk with them?

they must be excited about things

do you have any concept of how they came up with idea

or what other diseases they will target

who was the Dr. or phd behind the idea or company

how are your numbers

any word


Offline JPinLA

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Re: Starting VRX496
« Reply #70 on: June 09, 2007, 11:26:34 AM »
This is an interesting study and goodluck to you appleboy.  Participation by people like you in these trials ulitmately helps he greater community and to me it is very selfless.  So I thank you.

The PD-1 conversation has been occurring for sometime.  I'm not sure if I'm derailing this thread or not but the PD-1 receptor and it's cognate ligands PD-L(1) and PD-L(2) is a regulator of immune cell function and is expressed primarily on activated immune cells and is meant to maintain homeostatis of the cells in the body (i.e. a  balance between activated and inactivated cells).  The programmed death part refers to the conference of susceptibility of cells expressing PD-1 to programmed cell death or apoptotic signals (such as by Fas-ligand).  Programmed cell death is merely an organized and fairly well characterized process of cell death mediated by a signalling event.  PD-1s upregulation and interaction with its ligands inhibits activated immune cell functioning (e.g. responsivness to certain cytokines, production of cytokines...).  It provides and important function in non-chronic infections of ensuring the immune system does not go crazy.  In chronic infections, constant activation of cells, constant upregulation of inhibotry signalling mechanisms such as PD-1 and CTLA4 result in functional cell exhaustion and ultimate dysfunction.

Blocking of PD-1, suppression of infection through successful HAART and even treatment with stimulatory ytokines such as IL-2 could be good future therapies.   Also, monitoring of P-1 levels couldl be a good predictor of things going south....

Here's some current links..some may already hae posted these....

http://www.jem.org/cgi/content/full/203/10/2281#BIB21

http://bloodjournal.hematologylibrary.org/cgi/content/full/109/11/4593

Good discussion and it is a good area to focus on I think!

JP
11/06 - Diagnosed - VL/5784 & CD4 326
2/07 - VL/6000 & CD4 290 2/07
3//07 -Began Truvada/Viramune 
4/07 VL/undetectable and CD4 320 22%
7/07 VL/undetectable and CD4 286 22%
11/07 VL/undetectable and CD4 302 26%

Offline StandTro

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Re: Starting VRX496
« Reply #71 on: June 09, 2007, 02:54:31 PM »
[size=12I pray everything go well for you. Please keep me post it.
Thanks
pt][/size]
Will

Offline powerpuff

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Re: Starting VRX496
« Reply #72 on: June 12, 2007, 02:08:22 PM »
hi, i'm new
please be gentle.
i have been following this company since last year. it sounds promising i'm so happy the results are in.
i'm curious about  the risk factors i hear they changed somthing to reduce the risk of cancer...do you know what they did. please keep us posted. i hear there is another group possible 40 people in this study does this last for another two years?............... :-\ ::)
i think it would be a great treatment option! however do you think in the next few years you can see people hooked up to a machine for a few hours and then  be on their merry way??/
it would be a nice thought wouldn't it!
oh i live in Canada...i'm just really curious.  ::)

Offline powerpuff

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Re: Starting VRX496
« Reply #73 on: June 12, 2007, 02:23:56 PM »
hey jake that sounds interesting..so they are a little behind in phase 3 2007-2009 .
a ??? :-\ product to get out by 2009 interesting.thats cool so i guess it would take awhile to reach Canada ??? wouldn't the drug companys feel threatned i wonder? :-\

Offline powerpuff

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Re: Starting VRX496
« Reply #74 on: June 12, 2007, 03:15:28 PM »
I would want nothing but success for this!
I also have the same question either it will be expensive or can you imagine  millions of people lined up to a dialasis machine i america? ican't  ???
m
not enough machines? too expensive? hmmm only for the rich don't know still in trial 2
 :-\
questions hmmm

Offline Jake72

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Re: Starting VRX496
« Reply #75 on: June 12, 2007, 05:16:13 PM »
hey jake that sounds interesting..so they are a little behind in phase 3 2007-2009 .
a ??? :-\ product to get out by 2009 interesting.thats cool so i guess it would take awhile to reach Canada ??? wouldn't the drug companys feel threatned i wonder? :-\

Yeah, it appears that they may be a bit behind schedule unless a Phase III trial starts at the end of the year.  I wish I had more information about the trials.
I'm also in Canada, incidentally, and there seems to be a 6 month-one year lag time in therapy approval between the United States and Canada (and I'm presuming the European Union).  However, if this were really amazing, perhaps the lag time would be reduced.  Also, Appleboy posted that the company seems to think that local centres (maybe current clinics and HIV/AIDS service organizations?) would be set up for dialysis.  Since the procedure wouldn't be a frequent one (let's say once a year, once every other year, or...ideally, once ever!), I don't know how backed up the centres would be.
« Last Edit: June 12, 2007, 05:18:39 PM by Jake72 »

Offline appleboy

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Re: Starting VRX496
« Reply #76 on: June 12, 2007, 05:41:25 PM »
Whoa! I go on vacation and I loose track of this thread!  Tomorrow is the day for my intake into the VRX496 Study.  I am excited yet quite nervous how I am going to fit all this and my busy work schedule together.  Power I sent you answers to your question via a reply to your private message.  JP thank you for the kind words and the nice information.  Thanks Stand for the prayers.  I really hope and pray this stuff works and this can help the masses.  Power the price may still be cheaper than the cost of meds if this works.  So, keep an eye out on my blog and here I will try to keep you updated as to what is going on.  My counts as of my last lab work was  VL Undetectable with the ultra sensitive test and my CD4 was 517/25% .  I hope that answers all the questions and I did not leave anyone out.
AppleBoy
http://appleboyde.wordpress.com
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline Jake72

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Re: Starting VRX496
« Reply #77 on: June 12, 2007, 06:10:24 PM »
Woohoo on those lab results, Appleboy, and welcome back!  Good luck tomorrow...we're all behind you!

Offline StandTro

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Re: Starting VRX496
« Reply #78 on: June 12, 2007, 07:08:22 PM »
Hey AppleBoy, is all good.
Will

Offline powerpuff

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Re: Starting VRX496
« Reply #79 on: June 12, 2007, 09:41:05 PM »
 :D so a cd4 cell has a short life span. how does modified cells live up to a year or more in the body? memory cells produce more in the bone marrow???don't know how? but these guys were off meds for up to three years. so some how the cells must produce. right? ???

Offline hahaha

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Re: Starting VRX496
« Reply #80 on: June 13, 2007, 01:44:54 AM »
Send my best best wish from the other side of Pacific Ocean.  I hope you will all be fine..... ;D
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 #81 on: June 13, 2007, 04:39:50 PM »
Thank you HAHAHA!  I have updated my blog (http://appleboyde.wordpress.com/) with what happened today.  I will post it here below.

I am exhausted! I got up at 4:50 this morning to get ready to go to UPenn for my intake into VRX496. I was on the road by 5:45. I don’t like traffic so I decided that if I left that early the traffic would not be as bad. It was not all that bad thank goodness. The visit went great I met the study intake coordinator who is just awesome and my regular ID Dr ended up doing my physical so it was great to get to see her for a few minutes. They took 10 or so vials of blood for lab work. They are doing all kinds of tests including making sure I don’t have a antibody for the vector which carries the VRX changed HIV. They also are doing a Viral Load test that goes down to 30 (I think this the number she said and it is lower than the currently used Ultra Sensitive Viral Load Test. So now I wait. If I have the antibody for the vector I am out of the study. Which means my immune system will attack the VRX changed CD4 cells instead of accepting them which would defeat the purpose of VRX496. Next will be if my Viral Load is not undetectable with the Super Ultra Sensitive test then I am out of the study. So my fingers are crossed that my VL is undetectable and I don’t have the antibody to the vector. We talked a lot about the procedures and signed what felt like tons of paperwork. The whole goal is to make sure I am safe and that everything goes correctly. This made me feel so good. My safety is my most important priority. I pray and hope this stuff works and that I can be fully accepted into the study and if it does not work I just want to be safe which I don’t think will be a problem. I should know in a few weeks for sure and I have the date for the first CD4 cells collection which is July 2. So the waiting begins!
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline NYCguy

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Re: Starting VRX496
« Reply #82 on: June 15, 2007, 02:42:13 PM »
appleboy, thanks for your courage - it's amazing what you are doing and we're all watching and rooting and praying for you!
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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Re: Starting VRX496
« Reply #83 on: June 15, 2007, 05:38:50 PM »
Thank you NYCguy  :-*

I got word on part of the lab work done Wednesday.  Right now nothing to throw me out of the study.  I am still waiting for Viral Load and the Antibody for the VRX496 Vector.  More as I find out!

Triglycerides 157

Cholesterol 140

Hepatitis panel--non-reactive

CD4 533/24%

Lipase 94
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline o

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Re: Starting VRX496
« Reply #84 on: June 16, 2007, 06:22:06 PM »
dear delicious apple,
I am muchly touched with ur courage and dedication to our community.


will u marry me?


o

Offline appleboy

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Re: Starting VRX496
« Reply #85 on: June 16, 2007, 09:00:37 PM »
O,
If you have a Mac I will marry you!  If you use Windows I don't think I can do it!
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline fondeveau

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Re: Starting VRX496
« Reply #86 on: June 17, 2007, 09:15:01 PM »
O,
If you have a Mac I will marry you!  If you use Windows I don't think I can do it!

Gosh, it used to matter more how hung you were...what is this world coming to...tsk tsk....

Offline appleboy

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Re: Starting VRX496
« Reply #87 on: June 18, 2007, 10:40:45 PM »
Not so promising news....

I got a call that my Viral Load tests where back and they are 129 it has to be less than 30 to enter the study.  The viral load is not undetectable meaning right now I cannot be in the study.  So tomorrow I am going to give another tube of blood for them to do another VL test.  I am hoping this was just an odd spike.  If it is not my ID doctor wants me to change around my medications.  This will suck as it means one or two more co-pays a month.  But if we change meds we I can try again for the study in 4 weeks.  So lets hope it was just a blip if not life goes on we do what we have to do!  Blah, I am rather disappointed at this current moment but who knows what the next VL test is going to look like in a few days.
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline J220

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Re: Starting VRX496
« Reply #88 on: June 18, 2007, 11:47:33 PM »
Don't give up yet, your next vl might come up undetectable, and in you go...hang in there!
"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 o

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Re: Starting VRX496
« Reply #89 on: June 19, 2007, 01:26:35 PM »
Apple dear,
on the other side of the ocean, which we name Europe, people r not that muchly into MAC...
so from two different worlds we r, first the PCs didn't match.
and i know see that u might not get into the test...
well, i still have not changed my mind at all, i want a brave husband like u!
consider it thoroughly dear apple, condiser it thoroughly... :-D

Offline appleboy

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Re: Starting VRX496
« Reply #90 on: June 19, 2007, 02:20:15 PM »
Ok O I'll marry you and give you a mac for a wedding gift!
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline Central79

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Re: Starting VRX496
« Reply #91 on: June 20, 2007, 10:34:28 AM »
I'm in Yerp and I love my Mac...

M.
Diagnosed January 2006
26/1/06 - 860 (22%), VL > 500,000
24/4/06 - 820 (24.6%), VL 158,000
13/7/06 - 840 (22%), VL 268,000
1/11/06 - 680 (21%), VL 93,100
29/1/07 - 1,020 (27.5%), VL 46,500
15/5/07 - 1,140 (22.8%), VL not done.
13/10/07 - 759 (23.2%), VL 170,000
6/11/07 - 630 (25%), VL 19,324
14/1/08 - 650 (21%), VL 16,192
15/4/08 - 590 (21%), VL 40, 832

Offline appleboy

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Re: Starting VRX496
« Reply #92 on: June 20, 2007, 02:12:18 PM »
Damn!  Can I marry you both?
 ;D
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline o

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Re: Starting VRX496
« Reply #93 on: June 20, 2007, 04:21:13 PM »
dear apple, canu get married at States at all?
but my heart is urs... :-D

Offline appleboy

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Re: Starting VRX496
« Reply #94 on: June 20, 2007, 08:11:16 PM »
Since I had another VL draw on Tuesday I am hoping to hear either tomorrow or Friday what it was.  I am hanging in here just doing the usual waiting and researching the drugs my dr will change me to if it is indeed not under 30.  If the med change happens I will have to wait to try and reenter the study after 30 days of being on the new meds.  I will keep everyone up on what is going on soon as I know and can get to a computer to type it out.  Next, I want to thank everyone that has sent kind words and suggestions.  That honestly makes me feel good and it warms my heart.  So here is to better news I hope later this week!
Bill  :-*
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline bimazek

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Re: Starting VRX496
« Reply #95 on: June 25, 2007, 04:09:44 PM »
appleboy

can you keep in touch with other guys in the study and let us know thier experiences too

that would be really cool

if you meet someone there and keep in touch and they agree to tell you so you can let us all know

how you and they are doing



Offline appleboy

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Re: Starting VRX496
« Reply #96 on: June 25, 2007, 06:21:11 PM »
I have talked to one guy in the study and he has had 2 injections of his cells back and so far is doing ok.  He has not been pulled off meds yet.  He is the only person I have talked to.
If you are walking down the street and your pants drop to your ankles bend over pick them up and keep on walking!
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Offline appleboy

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Re: Starting VRX496
« Reply #97 on: June 25, 2007, 06:30:50 PM »
DAMN IT!  I just got back the second VL test results and it is 103.  The my VL has to be below 50 to get into the study.  I got an e-mail just after the one about the results from my doctor at UPenn and she said lets change meds and then attempt to enter the study again in 30 days.  So here is what has been suggested she is waiting till Wednesday's community meeting to see what the other doctors think.

1. Drop Sustiva component of Atripla and replace it with Atazanavir boosted with Ritonavir so I would be on Atazanavir, Ritonavir and Truvada.
2. Keep Atripla and add Abacavir.

I am leaning towards 2 since that would only add one co-pay to what I am paying now and my VL is very low.  So right now I am sitting and waiting for word from my doctor as to what we are going to do as far as meds once I start I will try to enter the study again in 30 days.


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

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  • Posts: 180
Re: Starting VRX496
« Reply #98 on: June 25, 2007, 06:39:24 PM »
Hey Appleboy
Thanks for keeping us posted.  Keep your chin up!  I really appreciate all the candid info.  As for your drug choices, I will just say that I have been on the reyataz (300) boosted with Norvir plus Truvada for 6 mo, and I have been pretty happy with it, or at least as happy as I can be knowing that I have to take something.  Almost no side effects (a bit of the runs for a few days, but no problem now as long as I eat enough) and none of Sustiva's craziness.  I went below 250 in 1 month then <50 after 2.  And I started out with VL over 250,000!  I would urge you to screw the co-pay and do what you and your Dr. think is best.  It's only money, after all...

Just my 2 cents
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 bimazek

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Re: Starting VRX496
« Reply #99 on: June 26, 2007, 04:19:45 PM »
good luck sounds like a good plan new meds

are you taking any multi vitamins or selenium, i think i saw an article that selenium seemed to give a small lowering VL and a small boost to T cells, also green tea

Offline appleboy

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Re: Starting VRX496
« Reply #100 on: June 26, 2007, 05:25:30 PM »
Selenium I am taking.  Multi Vitamin I am not. 
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

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Re: Starting VRX496
« Reply #101 on: June 27, 2007, 02:53:38 PM »
you might try adding a multi - just a normal one from the drug store is fine.  I do also know one guy in my group who thinks selenium helped his t-cells quite a bit.  I try to eat 2 brazil nuts every day, since they are hight in selenium.
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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Re: Starting VRX496
« Reply #102 on: June 27, 2007, 04:21:27 PM »
Ok here goes.  I talked to my Doctor today.  We are adding AZT to my Atripla.  Since we cannot get the Viral Load where we want it we are trying squash it early.  In 4 weeks we will try another attempt at the VRX496 Study.
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 appleboy

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Re: Starting VRX496
« Reply #103 on: July 21, 2007, 11:57:40 PM »
So I am soon coming up on one month of being on the AZT with my Atripla.  I just had blood work done this past week so I am waiting to see what we come up with.  If this blood work looks good then I am going to attempt entering the VRX496 study again.  Things that are stressing me out this go round like how in the world I am going to fit this into my crazy schedule with work.  I am so busy at work and I have 2 certifications to renew and 1 new one I am getting.  I am trying to not stress out and go with the flow since I want to do this study so bad.  So I will post the test results soon as I get them and then give the information on entering the study again.
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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Re: Starting VRX496
« Reply #104 on: July 22, 2007, 12:21:23 AM »
Hey Appleboy,

Thanks for the update!  Don't stress out about the trial, your results, or work.  Just take deep breaths and deal with one thing at a time.  As always, we are behind you 100%!


Offline J220

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Re: Starting VRX496
« Reply #105 on: July 22, 2007, 10:52:27 AM »
We are rooting for you all the way. Hopefully your labs will let you enter the trial. As far as things as things at work, well sometimes things just fall into place with time. Like Jake said, one day at a time! Cheers, 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 NYCguy

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Re: Starting VRX496
« Reply #106 on: July 23, 2007, 02:11:42 PM »
No matter what happens, just take care of yourself and do what you have to do.  You have all of our support.
Go Appleboy!
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 SASA39

  • Member
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Re: Starting VRX496
« Reply #107 on: July 23, 2007, 04:34:45 PM »
I`m not behind you ,but I`m at your side  100 %  ;D
Oct.     `06.  CD4=58  ?    %       VL not perform. ?!?
25.Dec.`06.         203       14        VL= 0
29.May.`07.    broken device        VL=1363
20.June`07     broken device        VL=0
25.Dec `07  CD4=582                  VL=70
14.May `08  CD4=448
29.July `08                                  VL=0
26.Nov `08  CD4=674                    VL=179
16.Mar `09  CD4=554                    VL=0
19.Jan`10 CD4=715               
03.Mar`10                                    VL=0
24.Aug`10 CD4=524                     VL=0
04.Dec`10 CD4=626                     VL=0
15.Sep`11                                   VL=93
17.Nov`11                                   VL=0
05/26 .Jul`12 CD4=713                 VL=0
28.Nov`12 CD4=916                     VL=0
09.May`13                                 VL=0

Offline appleboy

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Re: Starting VRX496
« Reply #108 on: July 23, 2007, 07:34:00 PM »
Thank you all!
 :-*
Bill
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 JamieD

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Re: Starting VRX496
« Reply #109 on: July 27, 2007, 04:34:49 PM »
I applaud your courage, appleboy. I don't think I could do a rectal biopsy.  :-\ And like redhotmusclebear said, I don't think could let someone mess with my t-cells unless it was extremely likely that it would produce great benefits to me. I would really have to know a lot more about the study in order to be in it, but people like you are what is going to give us more knowledge.
I am not really hopeful for a cure, but I am hopeful for things like this that will allow people to be off of medication for years at a time, thus saving money and giving the body time to recover from some of the damage that HAART does to it.

Offline appleboy

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Re: Starting VRX496
« Reply #110 on: July 29, 2007, 05:35:51 PM »
Thank you Jamie,
I have spent lots of time looking at this study and I feel confident that something is to be learned from it therefore helping all mankind.  Yes the rectal biopsy does not thrill me but it will be the most action it has seen in years!  Ok not the kind of action I want but what can you do but try to make fun of it?  I am hoping to visit the trial nurse during my normal ID doctor on Wednesday.  So soon I hope to have more news and continue giving information on this study.
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 appleboy

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Re: Starting VRX496
« Reply #111 on: August 01, 2007, 05:16:26 PM »
I got my VL back and it is 70 which is undetectable (<75).  I checked with the intake coordinator and she cannot do an intake till after September 10th.  So looks like another try in September!
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

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Re: Starting VRX496
« Reply #112 on: August 01, 2007, 06:09:25 PM »
Way to go, Appleboy....look like you'll be joining this trial! We all look forward to hearing your great results. 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 Jake72

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Re: Starting VRX496
« Reply #113 on: August 01, 2007, 07:10:50 PM »
Hey, great!!!  Congratulations on the super results, Appleboy!  Now go out and celebrate!

Offline NYCguy

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Re: Starting VRX496
« Reply #114 on: August 02, 2007, 05:05:30 PM »
Super-congrats from me as well!  September's just a heartbeat away and you'll probably have an even lower VL then.  Do some celebrating and enjoy the rest of summer!
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 FiercenBed

  • Member
  • Posts: 183
Re: Starting VRX496
« Reply #115 on: August 02, 2007, 06:16:25 PM »
sorry about the trouble w/ Virxsys apple. just catching up on post. like i said on a previous post i went to ny for the >5,000 vl study. i got bumped for an 'undiagnosed' case of ks. got the denial news on friday and sat on the couch & cried all day Saturday.....oh well.

anyway....they should be on phase three by now right? which would be a good thing for you. phase three was a pretty broad study with a lot of participants. one thing to keep in mind that i havnt seen in other post is the 'genetic junk' draw back.

once you do a genetic study ur considered 'genetic junk' <nice medical term huh>. if u do any genetic testing it makes u ineligible for any other type of genetic studies or programs. and there are several other studies in phase two. so make sure this is the one you wanna go with. the virxsys coordinator wouldnt give any guarantee of future treatment with the program if needed. there were questions about the legnth the treatment would last.

my doc sez stress affects vl so de-stress. easier said then done right?

that less <50 is a bitch:) good luck!
« Last Edit: August 02, 2007, 06:20:59 PM by FiercenBed »

Offline appleboy

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Re: Starting VRX496
« Reply #116 on: August 02, 2007, 10:08:17 PM »
Oh stress lovely stress!  My Lexapro helps with that some but I still have it.  Genetic junk never heard of this term.  The study I am looking at is phase 2 and that is currently the only phase that I know of with this.  I still feel strongly this is what I need to do so I am sticking to my guns.  I am sorry to hear about your KS and not being able to enter the study.  At least you found out about the KS instead of not knowing so I would say that is good you gave it shot. 

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

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Re: Starting VRX496
« Reply #117 on: September 17, 2007, 10:53:10 PM »
Any news Appleboy?? Keep us posted!
"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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Re: Starting VRX496
« Reply #118 on: October 09, 2007, 07:02:26 PM »
Well I have some bad news!  I had an appointment for another intake for the VRX496 study at UPenn in November.  I found out today that they changed the study around and that they are only accepting people with a CD4 nadir of no less than 250.  Nadir is the lowest CD4 count a person has ever had.  I have been as low as 168.  Since that is way below 250 I am now totally out of the study.  Here is what I found out.  Those with a nadir below 250 when pulled off meds in the study tend to have CD4s drop low again require the patient to be put back on meds.  So that right there sheds some light on this study a bit.  So right now it seems that study only seems to working of a person never has has a CD4 of less than 250.  I am not in the least disappointed that they found this out before me starting the trial.  I would have hated to gone through the complex procedures to only find out that it was not going to work.  I am glad that my VL is now below 48 and my CD4s are at 673.  So with that I did hit a goal of getting my VL down and and CD4s up.  With that I am closing this chapter of my life and I am proud of at least trying to get in this study.  I am more than grateful for the support from everyone here in the forums.  Without that push from everyone I don't think I would have ever had the balls to give this a shot.  THANK YOU ALL from the bottom of my heart!  :-*
Bill
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

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  • Posts: 183
Re: Starting VRX496
« Reply #119 on: October 09, 2007, 07:24:45 PM »
dude.....bad info....sorry  to hear this! i had mentionedi had gone through the whole VRX496 intake process in NY only to be bumped for having a 'possible' case of KS. it was like a roller coaster ride that flew off the tracks. god dam i was depressed so i kinda know how u feel.
im starting to have doubts about the VRX496 ability to treat HIV on a wide scale basis. they seem to be 'cherry picking' to get the best results, but i guess thats what clinical trials are for.
i do look at the whole experience as a major learning experience that bought my expectations back to reality. but hold tight therez gota b something else in the magical medical box!

good luck.

Offline J220

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Re: Starting VRX496
« Reply #120 on: October 09, 2007, 07:43:00 PM »
Well I have some bad news!  I had an appointment for another intake for the VRX496 study at UPenn in November.  I found out today that they changed the study around and that they are only accepting people with a CD4 nadir of no less than 250.  Nadir is the lowest CD4 count a person has ever had.  I have been as low as 168.  Since that is way below 250 I am now totally out of the study.  Here is what I found out.  Those with a nadir below 250 when pulled off meds in the study tend to have CD4s drop low again require the patient to be put back on meds.  So that right there sheds some light on this study a bit.  So right now it seems that study only seems to working of a person never has has a CD4 of less than 250.  I am not in the least disappointed that they found this out before me starting the trial.  I would have hated to gone through the complex procedures to only find out that it was not going to work.  I am glad that my VL is now below 48 and my CD4s are at 673.  So with that I did hit a goal of getting my VL down and and CD4s up.  With that I am closing this chapter of my life and I am proud of at least trying to get in this study.  I am more than grateful for the support from everyone here in the forums.  Without that push from everyone I don't think I would have ever had the balls to give this a shot.  THANK YOU ALL from the bottom of my heart!  :-*
Bill

Bummer...but hey like you said, at least you tried.

Now, about the trial, did they actually say that this therapy works only on people that have always been above 250? It's possble that the problem is that there is a time lag before the modified cells "kick in" as it were, but that due to safety parameters they can't have volunteers get below a certain threshold after being taken off meds, and thus they are required to re-start meds if that happens. Possible? As far as cherry picking for best results, I can't believe that's the case (but what the hell do I know), I do believe it's just a function of the specific parameters of the patient population they are targeting for the particular phase. Just a thought, or rather, a hope, that this is the case, and that this does work. Cheers 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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Re: Starting VRX496
« Reply #121 on: October 09, 2007, 08:13:32 PM »
Bummer...but hey like you said, at least you tried.

Now, about the trial, did they actually say that this therapy works only on people that have always been above 250? It's possble that the problem is that there is a time lag before the modified cells "kick in" as it were, but that due to safety parameters they can't have volunteers get below a certain threshold after being taken off meds, and thus they are required to re-start meds if that happens. Possible? As far as cherry picking for best results, I can't believe that's the case (but what the hell do I know), I do believe it's just a function of the specific parameters of the patient population they are targeting for the particular phase. Just a thought, or rather, a hope, that this is the case, and that this does work. Cheers J.

Well I am assuming that the problem is with a possible lag time meaning people drop below a certain threshold.  If that is the case I can understand totally that it might not be a good idea.  Cherry picking I seriously doubt.  They know from previous patients what is working and what is not and for that I again understand.  They are keeping people safe and that is priority one for any trial.
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

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Re: Starting VRX496
« Reply #122 on: October 10, 2007, 09:03:54 AM »
well mayb 'cherry picking' is too strong a word. i am using this word with regards to a successful outcome aka fda approval to the study. im a pessimist when it comes to pharma and hope this is about safety  .......but:

1) alot of people have or have had cd4 counts below 250.
2) alot of people are not 'undetectable' even with haart.
3) alot of people have an oi like ks.

you said yourself they are 'changing the study'. this 250 number was never mentioned in my interview and i was under 200 when diagnosed. obviously some new negative data came to the fore front to cause this exclusion. i would be curious to hear the specifics. i have never heard of changing a study parameter in the middle of research but i guess it is done. im sure this new exclusion was not done lightly. it just seems like they are trying to eliminate any possibility of any type of negative outcome.  this is really going to exclude alot of people from possible treatment.

on the bright side this may induce people to get tested sooner before they drop below 250.

Offline bimazek

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Re: Starting VRX496
« Reply #123 on: November 25, 2007, 03:01:35 AM »
any one have any news on this one???

Offline SASA39

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Re: Starting VRX496
« Reply #124 on: November 26, 2007, 01:56:29 PM »
No , thank YOU , buddy !
  THANK YOU ALL from the bottom of my heart!  :-*
Bill
« Last Edit: November 26, 2007, 02:08:45 PM by SASA39 »
Oct.     `06.  CD4=58  ?    %       VL not perform. ?!?
25.Dec.`06.         203       14        VL= 0
29.May.`07.    broken device        VL=1363
20.June`07     broken device        VL=0
25.Dec `07  CD4=582                  VL=70
14.May `08  CD4=448
29.July `08                                  VL=0
26.Nov `08  CD4=674                    VL=179
16.Mar `09  CD4=554                    VL=0
19.Jan`10 CD4=715               
03.Mar`10                                    VL=0
24.Aug`10 CD4=524                     VL=0
04.Dec`10 CD4=626                     VL=0
15.Sep`11                                   VL=93
17.Nov`11                                   VL=0
05/26 .Jul`12 CD4=713                 VL=0
28.Nov`12 CD4=916                     VL=0
09.May`13                                 VL=0

Offline ZCorker

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Re: Starting VRX496
« Reply #125 on: January 04, 2008, 09:14:49 PM »
I participated in this trial about a year ago, but didn't get anywhere.  I had two plasma pharesis and the study site decided not to infuse me because they couldn't prove to the FDA that there would any benefit.  I guess in vitro the cell count went down, but I will never know as to whether or not this was because there was no active agent to kill the virus in vitro or whether the treatment didn't work.  Previously I was advised that many of the patients cell counts went down and it took a long time for the cell counts to come back up.


Offline J.R.E.

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  • Joined Dec-2003 Living positive, since 1985.
Re: Starting VRX496
« Reply #126 on: January 04, 2008, 11:37:21 PM »
Current Meds ; Viramune, Epzicom, 40mg of simvastatin, 25 mg 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


Diagnosed positive in 1985,.. In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started on  HAART on October 24th, 2003.

 As of 8/25/14,  t-cells are at 402, Viral load <40

 Current % is at 11%

  
 63 years young.

Offline appleboy

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Re: Starting VRX496
« Reply #127 on: January 20, 2008, 07:27:49 AM »
I am alive and well!  Just been super busy!  I just celebrated my 30th B-day which means I am now officially old!  I am super excited to drop into the forums and see that my post is still towards the top of the list!  Makes me feel kinda special  ;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 flip408

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  • Posts: 21
Re: Starting VRX496
« Reply #128 on: January 21, 2008, 05:56:03 AM »
Isn't 30 now the new 20, I thought 50 was the new 40. 

"You're still a young man baaby,"  does anyone else remember Pablo Cruise?
Start where you are, use what you have, do what you can.    A Ashe
05/14/11  501  <50  20%
4/14/11  483  <50  19%
2/10/11    523  <50 18% start Rilpivr/trvda
11/15/10  470  <50
1/6/10    430  <50  16%
7/13/09  345  <50  12%
1/26/09  347  <50  16%
7/22/08  306  <50  6%
11/26/07 238 <50  8%
6/11/07  253  <50  5%
11/9/06  122  <50 7%
9/05/06  <25 >100000  PCP

Offline dico

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  • Posts: 108
Re: Starting VRX496
« Reply #129 on: November 02, 2014, 04:21:06 AM »
Up. No news about that trial ?
« Last Edit: November 02, 2014, 04:33:30 AM by dico »

 


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