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Author Topic: Viral load undetectable 1 month post Structured Treatment Interruption  (Read 4105 times)

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Offline adenylyl

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Slide 21
http://www.med.upenn.edu/cstr/documents/CSTRclassprotocoloverviewOctober262009.pdf

If the viral load stays undetectable... biggest :) ever!

Offline georgep77

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #1 on: November 18, 2009, 06:43:32 PM »
The zinc finger approach from Sangamo looks awesome !!! they are trying to replicate the CCR5 process involved with the Berlin patient.

http://www.thebody.com/content/art53674.html

http://www.sangamo.com/human/human_thera_overview.html#HIV

                        Keep the fingers crossed    8)

Come on Sangamo,  Geovax,  Bionor immuno, ...Make us happy !!!
+ 2008

Offline Cosmicdancer

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #2 on: November 18, 2009, 11:06:06 PM »
Hey Adenylyl, thanks for sending along that link.  News on slide 21 of the pdf that the patient is undetectable 1 month of starting the structured treatment interruption is very encouraging!  Let's hope he stays that way during the 12 week STI. 

I had some correspondence with U Penn researchers a couple of months ago regarding this study, and discussed it with my doctor, but he advised that I not participate in the study at this point since it's a Phase 2 trial, and the risks in altering my genes just aren't well known at this point compared to the risks of HAART.  He also told me that it's not going to eradicate HIV (it's not the same thing as the Berlin patient), only that it might control it more effectively for a period of time, how long is anyone's guess.  Based on my lab numbers, I fit the criteria for cohort 2, but that cohort is people on HAART with the highest t-cell counts who are undetectable on HAART, in other words the people with the least incentive to risk changing something that's working.

I know we all want to see one of the next generation of therapies come along and offer an alternative to HAART, but it's going to require some people to be willing to take a risk.  I'm glad some people are doing that perhaps without their doctor's endorsement, but it's surprising that the Cohort 1 trial hasn't started since that group of people has fewer treatment options.  According to Slide #20, there are less than 3,000 people in the US who would qualify for the Cohort 1 trial.  That surprises me.   

If we see good safety and effectiveness results with the first few people in this Cohort 2 trial, I'd be inclined to talk to my doctor again.  Any other people out there thinking about being guinea pigs? 
Summer, 2007 - &$#@?
November, 2007 - Tested poz, 300,000 vl, 560 cd4
Feb, 2008 - 57,000 vl, 520 cd4, started Atripla
June, 2008 - undetectable, 612 cd4
January, 2009 - undetectable, 670 cd4
May, 2009 - undetectable, 593 cd4
Sept, 2009 - 83 vl, 763 cd4, 34%
Dec, 2009 - undetectable, 889 cd4, 32%
April, 2010 - undetectable, 860 cd4, 31%
October, 2010 - undetectable, 800 cd4, 38%
April, 2011 - undetectable, t-cell test not done
October, 2011 - undetectable
April, 2012 - undetectable, 850 cd4, 39%
November, 2012 - undetectable, 901 cd4, 41%
April, 2013 - undetectable, 846 cd4, 36%
October, 2013 - undetectable
May, 2014 - undetectable, 784 cd4, 48%

Offline Inchlingblue

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #3 on: November 19, 2009, 12:17:32 AM »
Did I read it right and they only have one person who has enrolled in the whole study?

I would have thought that more people would be in this study. I would seriously consider doing this, I've researched it extensively and it is one of the more promising studies.

The main difference with the German patient is that this doesn't entail a bone marrow transplant (which essentially clears out the previous immune system). I think the idea here is that these ZFN-modified cells will overtake and become the dominant population. Wouldn't that mean that even if there is still CCR5-tropic HIV in reservoirs it would not be able to take hold once it leaves the reservoirs since the modified cells will lack the CCR5 co-receptor?

I thought it was interesting that, according to the link, only those in Cohort 1 would be required to be CCR5-tropic but not those in the other two cohorts. Not sure what that's all about.  
« Last Edit: November 19, 2009, 12:26:06 AM by Inchlingblue »

Offline MitchMiller

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #4 on: November 19, 2009, 02:21:35 AM »
The company published a press release that unfortunately, the subject was detectable again at six weeks.  At least he did better than average.

Offline Cosmicdancer

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #5 on: November 19, 2009, 08:23:34 AM »
They have other people enrolled in the study according to the researcher I corresponded with this summer.  The data just pertained to a single subject.  Let's see what the data shows when they provide updates at medical meetings.  If it can maintain stable CD4s, and a low viral load for years, it could serve as a therapeutic personalized gene therapy.  It would certainly be great if it could turn people into long term non-progressors. 

http://investor.sangamo.com/releasedetail.cfm?ReleaseID=425161

Data were presented in a student course at the University of Pennsylvania School of Medicine from a single subject treated with SB-728-T who, as part of the study, began a structured treatment interruption (STI) from his antiviral drug therapy four weeks after SB-728-T treatment. This subject was reported to have stable CD4+ and ZFN-modified T-cell levels and an undetectable viral load one month post STI initiation. Previous studies have shown that in subjects undergoing an STI, the average time to detection of an increase in viral load is two to four weeks. While this subject continues to demonstrate stable CD4+ T-cell counts and stable levels of ZFN-modified T-cells, by six weeks post STI initiation the subject had a detectable viral load.

Summer, 2007 - &$#@?
November, 2007 - Tested poz, 300,000 vl, 560 cd4
Feb, 2008 - 57,000 vl, 520 cd4, started Atripla
June, 2008 - undetectable, 612 cd4
January, 2009 - undetectable, 670 cd4
May, 2009 - undetectable, 593 cd4
Sept, 2009 - 83 vl, 763 cd4, 34%
Dec, 2009 - undetectable, 889 cd4, 32%
April, 2010 - undetectable, 860 cd4, 31%
October, 2010 - undetectable, 800 cd4, 38%
April, 2011 - undetectable, t-cell test not done
October, 2011 - undetectable
April, 2012 - undetectable, 850 cd4, 39%
November, 2012 - undetectable, 901 cd4, 41%
April, 2013 - undetectable, 846 cd4, 36%
October, 2013 - undetectable
May, 2014 - undetectable, 784 cd4, 48%

Offline leatherman

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #6 on: November 19, 2009, 10:06:57 AM »
Quote
This subject was reported to have stable CD4+ and ZFN-modified T-cell levels and an undetectable viral load one month post STI initiation. Previous studies have shown that in subjects undergoing an STI, the average time to detection of an increase in viral load is two to four weeks. While this subject continues to demonstrate stable CD4+ T-cell counts and stable levels of ZFN-modified T-cells, by six weeks post STI initiation the subject had a detectable viral load.
am I missing something here? Doesn't this say that normally doing an STI, patients begin to become detectable once again within 4 wks? any by 6 weeks this patient was once again detectable? ??? that really doesn't sound like news at all, unless it's news that this method isn't really working. and quite franky, what really can be taken away from the results of only one patient?
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline Inchlingblue

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #7 on: November 19, 2009, 10:13:34 AM »
The company published a press release that unfortunately, the subject was detectable again at six weeks.  At least he did better than average.

Do you have a link by any chance?

EDITED TO ADD: Just realized it was in Cosmicdancer's post.

I still don't understand why, according to that original link in this thread, the patients in Cohorts 2 and 3 were not required to have CCR5-tropic virus.

They don't specify the subject's viral tropism. It said he has had HIV for 17 years, making it likely that he has dual-tropic virus. Of course this treatment would not work with CXCR4-tropic virus.

The patient in Germany who appears to have been cured also had dual-tropic virus but he got his CCR5 deletion through a bone marrow transplant, which essentially kills the previous immune system altogether (in order to build a "new" one).

It's way too soon to tell if this ZFN study will pan out or not based on that one patient.
« Last Edit: November 19, 2009, 10:37:11 AM by Inchlingblue »

Offline leatherman

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #8 on: November 19, 2009, 10:16:46 AM »
the link from cosmicdancer says that info
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline mecch

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #9 on: November 19, 2009, 10:22:51 AM »
So this thread should change title to read:  viral load rebounds 6 weeks after treatment interruption!
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline tkeyspet

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #10 on: November 19, 2009, 10:49:34 AM »
So this thread should change title to read:  viral load rebounds 6 weeks after treatment interruption!

yes i think i agree with you mecch, hype but everything has to have a start haha,  ;D they might want to take it back to the lab to find out just why it had gone wrong.

Offline marius68

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #11 on: November 19, 2009, 09:26:32 PM »
In my opinion this is a very significant advance. Let's see why:

* As shown in slide 22 only 10-30% of the CCR5 modified cells had the CTGAT mutation which I presume is the most important (see slide 6). If we add to that the fact that not all CD4 cells were treated we see why the virus rebound. It makes sense and the fact that there was some delay points in the right direction. The mutation indeed protected CD4s from infection. Only the number of mutated cells was small to grant a longer virus "free" period.

* Existence of viable mutated cells may be enough to fight OIs and protect from AIDS. Auxiliary therapies (ex. Prof Sundhir Paul, Peregrine or Adaptimume approaches) that promise to fight the virus, could do the dirty job of gradually cleaning the body from the virus.

* From this study I just want to hear that it is safe!! That it works in practice  I've no doubts and these results seem to corroborate that. It's very good to see that the number of mutated cells is stable.

* Sangamo was awarded 14.5 million dollars from CIRM to develop the same ZFN technology for stem cells. If we have a continuous supply of mutated CD4s over time they will become the predominant kind.

http://investor.sangamo.com/releasedetail.cfm?ReleaseID=419462

I'm not pessimistic about these results. I'm actually very hopeful!! This treatment in combination with therapies that effectively fight the virus promise a functional cure in the short term, progressing to total eradication as the reservoirs are being exhausted.

Offline hahaha

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #12 on: November 19, 2009, 11:29:44 PM »
Question: How long does it take in Phase I to prove gene therapy is "safe"  and can go to phase II?
two year ? or more?
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 tkeyspet

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  • TK its me lol
    • http://comsoftlimbe.yolasite.com/
Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #13 on: November 22, 2009, 06:39:12 AM »
In my opinion this is a very significant advance. Let's see why:

* As shown in slide 22 only 10-30% of the CCR5 modified cells had the CTGAT mutation which I presume is the most important (see slide 6). "If we add to that the fact that not all CD4 cells were treated we see why the virus rebound".

It makes sense and the fact that there was some delay points in the right direction. :-\

 The mutation indeed protected CD4s from infection. Only the number of mutated cells was small to grant a longer virus "free" period.  ;D True mr

* Existence of viable mutated cells may be enough to fight OIs and protect from AIDS. Auxiliary therapies (ex. Prof Sundhir Paul, Peregrine or Adaptimume approaches) that promise to fight the virus, could do the dirty job of gradually cleaning the body from the virus.


I'm not pessimistic about these results. I'm actually very hopeful!! This treatment in combination with therapies that effectively fight the virus promise a functional cure in the short term, progressing to total eradication as the reservoirs are being exhausted.

while i agree with you that the mutated cells were short in numbers, i really dont think this will get off any time soon, i think they already have the trick to protect the cells here but they cant sustain it, when i read a gene therapy the next step is make sure they sustain the cells like take hold of the bone, in my view we need the bone marrow to produce the mutated cells, if thats done or there is some way of sustaining this, the this will be interim cure.

and talking of phases, i was reading that site is say phase 1/2, whatever phase it is when they have a way to sustain those cells, then it will be a historic moment. according o my calculator its about 2 or 3 years from now so lets just take our meds and wait
« Last Edit: November 22, 2009, 06:41:31 AM by tkeyspet »

Offline dadx4

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #14 on: December 04, 2009, 08:34:09 AM »
Question: How long does it take in Phase I to prove gene therapy is "safe"  and can go to phase II?
two year ? or more?

They have already started a second phase I,  I would guess that phase II would start this next summer.



http://investor.sangamo.com/releasedetail.cfm?ReleaseID=410950

Offline sensual1973

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #15 on: December 04, 2009, 09:54:37 AM »
a second phase I ? i thought there is only one phase I !!!
God grant me the serenity to accept the things i can not change.

Offline leatherman

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Re: Viral load undetectable 1 month post Structured Treatment Interruption
« Reply #16 on: December 04, 2009, 10:00:11 AM »
a second phase I ? i thought there is only one phase I !!!
in the very first few lines it states that this is Phase 1 of a repeat dosing trial
previously since 2/09 (and still ongoing) was a Phase 1 single dosing trial
Quote
application to initiate an open-label, repeat-dosing Phase 1 clinical trial (SB-728-T-902) of the company's ZFN-based therapeutic, SB-728-T. A single dose Phase 1 clinical study of SB-728-T was initiated in February 2009 and is ongoing
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

 


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