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Author Topic: Virxsys/U. Penn VRX496 trial for well-controlled HIV still recruiting  (Read 2886 times)

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Offline Jake72

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As we've discussed on here, Virxsys is testing its VRX496 vector gene therapy approach on a variety of HIV+ patients.  It is collaborating with the University of Pennsylvania on a Phase I/II trial to see whether HIV+ patients whose virus is well-controlled in HAART can receive the gene therapy and subsequently go off their meds. 

I wrote to Larisa Zifchak, RN of the University of Pennsylvania to find out the status of this trial, and she sent me this reply indicating that they are indeed still recruiting.  It's being held in Philadelphia, with a subsite in New York.  I would sign up, but it is a bit far for me to travel on a regular basis.

"Thanks for writing and thank you for you interest in the gene therapy trial currently in progress here at the University of Pennsylvania. I am still recruiting for the study and need healthy individuals with HIV who have an undetectable viral load and a CD4 count of > 350. You would receive 6 doses of your own cells that have been modified by a vector. After you receive the 6 doses, you would be asked to go through a structured treatment interruption, (stop your meds) to see if your virus is controlled by these modified cells.
 
The study is quite involved and requires participants to come to the University of Penn for study visits (sometimes once a week). You do not mention where you live,,,are you close to Philadelphia?
 
I am attaching a consent form for the study. You do not need to sign it. It contains valuable information about the study and its requirements. Please call me with any questions you may have. I encourage potential participants to share the info with their doctors as well. After you read the consent and if  you are interested, we can set up a screening date. Although participants are compensated for participation, there is no compensation for travel or overnight stays, if that is required for you.
 
Please contact me with any further questions."

If anyone is interested, contact Larisa Zifchak at Larisa.Zifchak@uphs.upenn.edu or at 215-349-8091.

Here's some more info on the trial: http://clinicaltrials.gov/ct/show/NCT00295477?order=1

Offline powerpuff

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  • Posts: 138
Hey, any word on apple boy on this? how is it working on him? 8)

Offline ARMANDO

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has anyoneheard of a new drug not yet out on the market called MARAVIROC made by PFIZER? i was approached by a representaive when i went to my last doctors appt.MY doctor is currently working with pfizer to perform a research study using the drug.I am presently undectectable but my cell count is at 203.I have never really had a  high cell count,usually between 200-350,over the past 15 years. MY DOCTOR THINKS THAT I WOULD BE A GOOD CANDIDATE SINCE I HAVE DEVELOPED RESISTANCE TO MOST OF THE DRUGS EXCEPT FOR THE ONES THAT I AM CURRENTLY ON.I WOULD APPRECIATE ANY FEEDBACK CONCERNING THIS SUBJECT.

Offline J220

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  • Posts: 587
Hi Armando, here is a link that talks about Maraviroc:

http://www.sciencedaily.com/releases/2007/08/070810082521.htm

Also, keep an eye on a medication called Isenstress, which should (if all goes well) be approved before the year is over:

http://www.cleveland.com/news/plaindealer/index.ssf?/base/news/1172914390144500.xml&coll=2

_____________________________

Now, getting back to VRX496, I have a question regarding this gene therapy.

As I understand it, your immune cells are harvested, and modified with a "viral vector expressing a genetic antisense targeting HIV". In other words, a modifief, non-disease causing HIV vector. Once the t-cells have integrated this VRX496 RNA/ DNA, they are protected from HIV, and not only that, but when HIV particle tries to highjack the cell to make it churn out more copies, instead they put out the modified version which actlauuy binds and kills off the HIV RNA. Great, so far so good. I am very excited about this therapy.

Now here's the question. What will happen when a vaccine is developed that succeeds in stimulating the body to create HIV antibodies? Will the VRX496-bound cells be incorrectly identified by HIV-antibodies as a pathogen, and kill them too? Since these modified benign cells have a kind of HIV in them, will they cause the antibodies to attack these cells too? Just curious. J.


I know I am getting ahead of things here, but I was wondering about this. T
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Offline appleboy

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I am awaiting a another intake appointment with Larisa.  So soon as I have an appointment set in stone I will update you all on what is cooking.
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 powerpuff

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  • Posts: 138
Thanks sweetie  :-* :-* :-* your my favorite brave boy :-* :-* :-*
so many intakes so they haven't infused you already?
I thought they would by now! :o
so they are taking more people how come? did something happen to the others???/
Iwould love to participate but live in Canada,
Did they get rid of the Cancer risks yet??? ???
keep in touch,

Offline david3012

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  • Posts: 8
Excellent news - its so good to see officially that the drugs are helping us :-)

Offline appleboy

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The cancer risk is still there but sheesh cancer risk is about everywhere so I am super concerned.  No, I have not been infused because my VL was not low enough to get in the study hence why I started AZT so I could get it down enough to enter the study.  Still waiting for another intake appointment to get approved to be in the study.

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 powerpuff

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  • Posts: 138
appleboy
has anyone followed the first  guy it worked on named michael duname or something, is he still  :-\undetectable with infused cells?is he doing well?

Offline Miss Philicia

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I wonder if I should sign up for this.  I mean, it's only a 10 minute subway ride away :)

I'm scared of Phase 1/2 trials though.  Maybe when it's in 3?
"Iíve slept with enough men to know that Iím not gay"

Offline appleboy

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  • Just me!
Re: Virxsys/U. Penn VRX496 trial for well-controlled HIV still recruiting
« Reply #10 on: August 25, 2007, 09:57:24 PM »
Philly,
I would say go for it.  I have researched this and I feel comfortable with it.  But, don't do it just because I suggest.  Make sure you fell comfortable with doing it.  The staff at UPenn is wonderful and think of the many people this could help!
Hugs
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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