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Author Topic: Clinical Trial Volunteers needed in Dallas, Iowa, and Miami...plz read.  (Read 1547 times)

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Offline J220

  • Member
  • Posts: 587
Hi everybody. I have been in touch with the trial coordinator from Virionyx, they are currently working on Phase II of their caprine HIV-antibody PEHRG214 vaccine. They are expanding their locations for this second phase, but in order to begin the complete recruitment of 60 patients in each location (Dallas, Iowa City, Miami, New York, and Los Angeles) they need to have 4 pilot patients in each location, treated for two months.

At issue here- as I've been explained- is to recruit the pilot patients as soon as possible, so the main part of the recruitment can proceed, in particular before funding for the trial runs out. Therefore, they are seeking patients who want to participate in these locations. The basic inclusion parameters are CD4 <200 and VL >1000. The clinical trial site is:

http://www.clinicaltrials.gov/ct/show/NCT00385567.

The website of the company (I am not affiliated to them, I just took the time to write to them last year to inquire about their vaccine candidate which seems promising, and we have corresponded a few times since then), is http://www.virionyx.com/internal.aspx?mode=17&mast=mast4.jpg

Also, they wanted to get some input on how to best reach candidate patients in the mentioned cities. They are ready to do advertising to that effect, but wanted to have an idea on what is the best media venue for that. So if anyone has any particular ideas for how to disseminate the needs for this trial let's see if we can help them.

About this particular vaccine, we have had a few threads here about it, but in short, from their website:

"PEHRG214 is a polyclonal antibody therapy that targets multiple epitopes on HIV that are not recognised by the human immune system, are highly conserved, and functionally important. The antibodies are extracted and purified from plasma from goats immunised with a combination of HIV viral lysate and selected peptides and recombinants. In vitro and in vivo, these antibodies are responsible for the lysis and/or neutralisation of multiple laboratory and wild strains of HIV and the discriminative lysis of infected CD4 cells. These results have been obtained at concentrations achievable in man.

Potential AIDS Remission. There are patients from early compassionate studies (pre-HAART era) in Mexico, Dallas, and Auckland (New Zealand), who had AIDS when treated, became asymptomatic post treatment, and who anecdotally have remained free of AIDS related symptoms for several years, in some cases in the absence of subsequently available HAART (Mexico and Auckland). We hypothesise that treatment with HIV specific polyclonal antibodies may have significantly reduced the total HIV viral bioburden in these patients. If correct, these patients have been provided with a period of AIDS “remission” with the related positive connotations this term would invoke."

That sums it up. Let's see if we can help them get the patients they need so they can take this to the full phase II. Thanks eveybody, J.
« Last Edit: April 15, 2007, 04:06:33 PM by J220 »
"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

  • Member
  • Posts: 145
Thanks, J!
Participants are required to be on a stable HAART regimen.  If the results are good, how will the researchers know whether the promising numbers were due to the vaccine, HAART, or both? 

Offline J220

  • Member
  • Posts: 587
By comparison with the control patients, I believe, and other clinical data, I'm sure. But that is an excellent question for them. Feel free to write to them, they have been great in replying any time I've written to them.
"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 jpy865

  • Member
  • Posts: 34
Hi All,
I know this is a touchy subject but I think they need to find out different ways of attacking the virus.  They also need to find prevention methods that work 100%.  Vaccine, Microbicides, whatever?  For all of us, therapuetic vaccines, new treatments, again whatever - after all of that cure anyone........
Diagnosed November, 2005
Medications: Truvada (NRTI), Kaletra (PI)
02/08
Cd4 = 735
VL = <50

Offline J220

  • Member
  • Posts: 587
Hi All,
I know this is a touchy subject but I think they need to find out different ways of attacking the virus.  They also need to find prevention methods that work 100%.  Vaccine, Microbicides, whatever?  For all of us, therapuetic vaccines, new treatments, again whatever - after all of that cure anyone........

Please keep the thread on topic...feel free to start a new thread with your post as subject, but please don't hijack threads. Thanks, 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

 


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