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Author Topic: I am going to be in an IL-7 study soon  (Read 4282 times)

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Offline JamieD

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I am going to be in an IL-7 study soon
« on: October 07, 2007, 08:04:27 PM »
Hey Guys!

I am going to be in an IL-7 study starting in November. I am actually REALLY excited. The study compensates a HUGE amount of money. It is an uncontrolled, treatment trial for people with CD4 cells between 101 and 400 (I hope mine doesn't go above 400 before next month  :-\) and undetectable viral loads.

I have a few concerns about it though, and have only spoken with the study investigators briefly. I want to go in well informed though. My research thus far is not encouraging. It seems that IL-7 levels are already high in people with AIDS (HIV, whatever) so why are they trying to make it even higher? This one study I found compared people with HIV, ARC (AIDS related complex), and AIDS and those with ARC and AIDS had much higher plasma levels of IL-7 then those who were just HIV. So wouldn't that suggest this is a bad thing? Are they trying to make a bad thing even worse?
The study investigators seemed to make it look like IL-7 was some miracle in a vial. They said that it is going to have all the benefits of IL-2 with a much safer side effect profile. When I asked them about their predictions for the results of the study they said that they felt that IL-7 would raise CD4 cell counts and possibly reverse some of the damage HIV has done to the immune system.

I am very excited about the possibility of higher CD4 cell count, but not if its going to make things worse for me. I have also seen in vitro data that suggest that IL-7 may contribute to HIV associated neurological complications. I simply can not deal with that. I still have all my mental faculties about me, and don't plan to lose them. They study investigators said that that was old data, and not applicable to humans.

Can anyone help me to make a more informed decision?

Offline milker

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Re: I am going to be in an IL-7 study soon
« Reply #1 on: October 08, 2007, 03:40:59 PM »
Hi Jamie,

I can't comment on Interleukin-7 but anything that references ARC must be old studies. This term has not been used for years.

Milker.
mid-dec: stupid ass
mid-jan: seroconversion
mid-feb: poz
mar 07: cd4 432 (35%) vl 54000
may 07: cd4 399 (28%) vl 27760
jul 07: cd4 403 (26%) vl 99241
oct 07: cd4 353 (24%) vl 29993
jan 08: cd4 332 (26%) vl 33308
mar 08: cd4 392 (23%) vl 75548
jun 08: cd4 325 (27%) vl 45880
oct 08: cd4 197 (20%) vl 154000 <== aids diagnosis
nov 2 08 start Atripla
nov 30 08: cd4 478 (23%) vl 1880 !!!!!!!!!!!!!!!!!!!!!!!!!!
feb 19 09: cd4 398 (24%) vl 430 getting there!
apr 23 09: cd4 604 (29%) vl 50 woohoo :D :D
jul 30 09: cd4 512 (29%) vl undetectable :D :D
may 27 10: cd4 655 (32%) vl undetectable :D :D

Now accepting applications from blowjob ninjas™

Offline fearless

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Re: I am going to be in an IL-7 study soon
« Reply #2 on: October 09, 2007, 05:04:28 AM »
Hey Jamie,

Ignore the $ signs that are flashing before your eyes and get some further information about this trial. Did they any paperwork yet setting out what the trial is about, how it will be conducted etc? If so, please read it carefully.

I'm not up to date on the current state of research by any means. However, please double check exactly what the trial is. Cytheris, the company developing IL7 made a recent announcement about Phase II trials, but my memory is that it was a blind placebo controlled trial, not an uncontrolled trial as you state. So, I went and checked their website and in September 2007 they announced at http://www.cytheris.com/press/070926_Nobel_En.pdf:

"About the HIV Study

The HIV trial (CYT107-06) is a randomized placebo controlled, single-blind multi-center dose-escalation study of chronically HIV-infected patients with CD4 T-lymphocyte counts between 101-400 cells/mm3 and plasma HIV RNA < 50 copies/mL after at least 12 months of Highly Active Anti-Retroviral Therapy (HAART). The trial will be conducted at sites in the US, Canada, France and Italy."

Also, before being accepted into the trial they will need to assess your eligibility. From your other posts I thought you had only started HAART in the last 4 to 6 months, not the required 12 months. I'm not sure what you've told the trial investigators so far, but please be honest with them. The fact that you are suffer bulimia, self prescribe/medicate with drugs purchased off the internet, and don't adhere to dosage for meds prescribed by your doctor may all be factors that affect your eligibility to participate. Now, I'm not sure how they enrol people for trials in the US, but here I had to fill in a questionnaire, give them permission to view my medical records and then discuss anything in my medical records that needed clarification. So anything you've told your doctor they will know about.

If you are eligible then the decision is up to you and you only so don't let anyone pressure you. If I were you though, I would concentrate on dealing with your current issues and skip the trial. Are you sure you could deal with the stress of yet another potentially unknown, when you  don't seem ready to deal with the other more pressing issues you have talked about elsewhere?

And, from what you have said, your cd4's seem to be responding to your current treatment quite well in the few months you have been on HAART. You have to live with HIV for the rest of your life, your cd4's will not rebound over night but with small steady steps you can and will make good headway over time.

Just my 2 cents.

Steve

Be forgiving, be grateful, be optimistic

Offline JamieD

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  • Posts: 259
Re: I am going to be in an IL-7 study soon
« Reply #3 on: October 09, 2007, 10:00:25 AM »
I'm sorry, but that is not the study I am enrolling in. The study I am enrolling in very clearly states that it is am uncontrolled study. It is run by the NIH, not a pharmaceutical company.

Offline vokz

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Re: I am going to be in an IL-7 study soon
« Reply #4 on: October 09, 2007, 10:35:18 AM »
This probably sounds like a stupid question; but are you really sure that this is an HIV trial?

Could it be an oncology trial?

Offline penguin

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Re: I am going to be in an IL-7 study soon
« Reply #5 on: October 09, 2007, 11:06:35 AM »
jamie-
the only study I can find that is looking at il-7 in hiv infection in the us is this one (appears to be what yr describing though)
But, it is listed as not recruiting, as it has already started..?

The idea behind using Il-7 is kinda 2-fold as I understand it -  tcell increase, due to the signals it sends to cause cd4 cells to reproduce, & the thymus to produce more cd4 cells; and that short-term activation of hiv by Il-7 stimulates the pool of latently infected cells & can help to “flush out” viral reservoirs (and then HAART can destroy them - hence the importance of being on an actively suppressive regime for this trial)

The most recent study on this I can find is from 2005, info from natap (small tiny print, get yr magnifying glass out) http://www.natap.org/2005/HIV/010405_01.htm  it was a very small study though, like 14 people < this is always important

The points steve makes are very valid, do consider these things carefully. $$ is always attractive, but not a reason to enter a trial for anything stronger than cough sweets (in my book, anyways)

kate

Offline JamieD

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  • Posts: 259
Re: I am going to be in an IL-7 study soon
« Reply #6 on: October 09, 2007, 11:59:14 AM »
That is the study I am going to be in. They ARE recruiting at the Maryland site, but the study has not started yet. They are getting people's paperwork done, and accepting people into it. They are not yet administering the IL-7, though. They said they will start dosing in November.

Offline vokz

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Re: I am going to be in an IL-7 study soon
« Reply #7 on: October 10, 2007, 03:22:48 AM »
I am pretty sure that the second of those trials is just a subset of the other .. and has exactly the same entry criteria (under which you don’t appear to qualify). That is why I am wondering if it is one of the non-HIV branches of the trial.

Offline JamieD

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Re: I am going to be in an IL-7 study soon
« Reply #8 on: October 10, 2007, 10:24:25 AM »
Dude! I do qualify for the study. Don't assume. Go to the bottom of that page and look at the criteria. The only one I don't meet is being on HAART for more then a year and the study investigators said it was not a problem. I don't understand how you are going to tell me I don't meet the criteria when I am already enrolled in the study and waiting for it to start so that they will give me IL-7 injections.

Offline vokz

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Re: I am going to be in an IL-7 study soon
« Reply #9 on: October 10, 2007, 12:15:08 PM »
1: I suggest you learn to read then; because I assumed nothing and didn’t say that you didn’t qualify. I simply said you did not “APPEAR” to qualify.

2: It is precisely because I did bother to read – and because I happen to know that the trial you said you aren’t a part of is a part of the same trials that you said you are a part of – that I said that you do not appear to qualify.

3: You still don't appear to qualify.

4: Don’t EVER call me “dude” again.

Now if you have information that you have chosen not to share, and which isn’t in the public domain, then fine .. but kindly don’t expect us to be able to read your mind.
« Last Edit: October 10, 2007, 12:19:43 PM by vokz »

Offline milker

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Re: I am going to be in an IL-7 study soon
« Reply #10 on: October 10, 2007, 12:29:30 PM »
Is it this one? http://clinicaltrials.gov/ct2/show/NCT00477321

As an aside, I typed "clinical trials" in google and it came with a new search template that I had never seen before !

http://www.google.com/base/s2?q=&hl=en&gl=us&sa=X&oi=gb_refinement&ct=title&a_n0=clinical+trials&a_y0=9&a_o0=0&a_n1=Condition&a_y1=1&a_n2=Phase&a_y2=1

Milker.
mid-dec: stupid ass
mid-jan: seroconversion
mid-feb: poz
mar 07: cd4 432 (35%) vl 54000
may 07: cd4 399 (28%) vl 27760
jul 07: cd4 403 (26%) vl 99241
oct 07: cd4 353 (24%) vl 29993
jan 08: cd4 332 (26%) vl 33308
mar 08: cd4 392 (23%) vl 75548
jun 08: cd4 325 (27%) vl 45880
oct 08: cd4 197 (20%) vl 154000 <== aids diagnosis
nov 2 08 start Atripla
nov 30 08: cd4 478 (23%) vl 1880 !!!!!!!!!!!!!!!!!!!!!!!!!!
feb 19 09: cd4 398 (24%) vl 430 getting there!
apr 23 09: cd4 604 (29%) vl 50 woohoo :D :D
jul 30 09: cd4 512 (29%) vl undetectable :D :D
may 27 10: cd4 655 (32%) vl undetectable :D :D

Now accepting applications from blowjob ninjas™

Offline Tim Horn

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Re: I am going to be in an IL-7 study soon
« Reply #11 on: October 10, 2007, 01:23:32 PM »
vokz:

Seems to me as if you have an axe to grind here.

There's nothing to suggest that the NIH study JamieD is considering is a substudy of the clinical trial referenced by Fearless. Don't confuse the "CYT 107" designation with the actual study -- CYT 107 is the coded name for the Cytheris interleukin-7 formulation being studies. CYT 107 is included in the identifying number of various IL-7 studies -- this doesn't make it the same trial, a substudy, or even remotely related.  For example, CYT107-04 is a melanoma trial, whereas CYT107-05 is a hepatitis C trial.

Second, I'm not reading anything here to suggest that JamieD "STILL" doesn't qualify. The investigator has told him that the >12 month duration of antiretroviral therapy may not matter here.

Tim Horn

Edited to add: Jamie -- have you actually visited the clinic, undergone a full physical and blood work, and signed a consent form and other documentation? If not, you're still not in the study. It could be that you're a candidate for participation, but still need to undergo extensive screening and such.
« Last Edit: October 10, 2007, 01:31:40 PM by Tim Horn »

Offline vokz

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  • efavirenz junkie
Re: I am going to be in an IL-7 study soon
« Reply #12 on: October 10, 2007, 01:37:19 PM »
vokz:

Seems to me as if you have an axe to grind here.

Well you would be very wrong then.

I am not confusing the CYT107 designation. I am reading the publicly available information on the Cytheris trials (which are co-chaired by Irini Seretifor of the NIH and for which NIH is the partner on the US branch) - and that makes the trial he claims to be a part of very much related to the Cyteris trial mentioned by Fearless.

As I said, if he has been told something that is not published, then that is fine .. but based on what is published he just doesn't appear qualify for the HIV branch of that trial.

I am simply trying to establish exactly which part of the trial he was a part of (there are also HCV and oncology branches)so I could send him the relevant information - but given his attitude problem and his impression of the terminal end of the elementary canal, I certainly wont be bothering.
« Last Edit: October 10, 2007, 01:39:13 PM by vokz »

Offline JamieD

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Re: I am going to be in an IL-7 study soon
« Reply #13 on: October 10, 2007, 04:43:30 PM »
Edited to add: Jamie -- have you actually visited the clinic, undergone a full physical and blood work, and signed a consent form and other documentation? If not, you're still not in the study. It could be that you're a candidate for participation, but still need to undergo extensive screening and such.

I have signed consent forms, and W-2 forms (I think they were W-2). They said all the official stuff like the physical, administration of the drug, etc will not be taking place until the beginning or middle of November. I was completely open about my Bulimia and history of severe obsessive compulsive disorder. The study exclusion criterion states that these things must be "considered as significant by the investigator". I have been completely open with the investigator and he has not expressed concern about my being in the study. I have been in contact with these people since the beginning of July concerning this study.

Offline bimazek

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Re: I am going to be in an IL-7 study soon
« Reply #14 on: November 09, 2007, 12:49:20 AM »
jamie congrats on your helping us all by being part of a trial

any news

any new developments?

did you start?

Offline bobino

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Re: I am going to be in an IL-7 study soon
« Reply #15 on: November 11, 2007, 03:40:54 PM »
- but given his attitude problem and his impression of the terminal end of the elementary canal, I certainly wont be bothering.

Huh?  Do you mean "alimentary canal"?


Suivons les rivičres
Gardons les torrents
Restons en colčre
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Offline Matty the Damned

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Re: I am going to be in an IL-7 study soon
« Reply #16 on: November 11, 2007, 03:42:14 PM »
-snicker-  :D

MtD

 


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