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Author Topic: Clinic Trials or Not?  (Read 3220 times)

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Offline ibacowboy2

  • Member
  • Posts: 4
Clinic Trials or Not?
« on: March 08, 2007, 02:33:55 PM »
Hello, I'm new here so bare with me.......I have to begin treatment because my virals keep going up and my CD4 counts are hoveringin the low range. I've been asked the question do i want to join a clinical trial. It puts me in one of 4 groups with a whole bunch of abbreviations for drugs i'll be on. bottom line is...is this a good idea or not?? has anyone else done them? how did it go? even if you said no maybe an idea on the reasoning might help me decide.....thanks everyone

Offline megasept

  • Member
  • Posts: 478
  • Steven here...
Re: Clinic Trials or Not? I gotta wholelottaquestions!
« Reply #1 on: March 09, 2007, 12:46:22 AM »
Hello, I'm new here so bare with me.......I have to begin treatment because my virals keep going up and my CD4 counts are hoveringin the low range. I've been asked the question do i want to join a clinical trial. It puts me in one of 4 groups with a whole bunch of abbreviations for drugs i'll be on. bottom line is...is this a good idea or not?? has anyone else done them? how did it go? even if you said no maybe an idea on the reasoning might help me decide.....thanks everyone

I hear you...Acronyms, Alphabet Soup. Confusion!

Some patients try to learn everything about our choices and our illness; others like to rely on their MD alone. I hope you have decided to join the first group, partnering with your MD, not being subordinate (it's your health on the line). The meds I took were my own choice through reading the literature I could find---and understand---in the 1990's. I asked my new MD if she agreed with my choice, or had a better idea. She agreed.

You want my blood, fine, but if you want to put something into my blood, I've got a whole lot of questions. When I am dead dissect me, freeze me, pickle me, I don't care.

I have been in several Studies, but never a trial. I like helping out with research. But my health comes first. One time a study that simply took my blood and read my chart screwed things up for me by not allowing me access to my own lab results for 3 1/2 weeks (a RN went on vacation and nobody seemed to know anything)! Live and learn...  >:(

IS PARTICIPATION IN THIS TRIAL THE BEST MEDICAL CHOICE AVAILABLE TO YOU? Will it give you access to some treatment, your specialist thinks superior to everything available to you? Is there a "control group" that will receive nothing at all (that doesn't sound good for you if you need treatment now)?

I have one more question for you: Do you feel entitled to the very best hiv treatment available? If "Yes" then how do you plan on getting that treatment? If "No", why not? Squeaky wheels do get more attention.

Good Luck in your choice!  8)  -megasept

Offline Central79

  • Member
  • Posts: 527
Re: Clinic Trials or Not?
« Reply #2 on: March 11, 2007, 12:50:50 PM »
Hey

Welcome to these forums and your first post - I hope you post more, and find them as welcoming and supportive as I have.

I think it's really important to ask questions before agreeing to be put in a clinical trial. Most trials compare a new treatment for a disease against the BEST treatment currently available. It would be unethical to deny you treatment you needed by randomising you into a placebo group, who would receive nothing! The risk comes if you get randomised into the new treatment group, and it turns out to not be as good as the current best treatment that you would otherwise have been on. An example of this are the people who were randomised to treatment interruptions vs continuous therapy recently and did much worse, and had to be halted early.

So like megasept says, make sure the study is well designed and you understand what it's trying to compare. If it's a new treatment vs best current treatment look at the new treatment and ask yourself what the consequences of it not working for you are. If there's a possibility of failing with resistance on the new therapy (ie. being resistant to an entire class of drugs like the NNRTIs) then at least you know about it. Ask whether there is any independent monitoring to stop a trial early if a statistically significant difference in results is seen. It's unethical to consider a trial once you know that one group of people are on an inferior therapy.

All in all, most trials are well-designed and scrupulously performed. You may benefit from a new treatment or help advance science, which feels rewarding. But you need to be aware of the downside for you as an individual. It's difficult persuading most treatment-naive patients to take a risk these days, as first line therapy for most people is so good...

Best of luck,

Matt.
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 whizzer

  • Member
  • Posts: 363
Re: Clinic Trials or Not?
« Reply #3 on: March 11, 2007, 08:47:43 PM »
I think the study you are referring to in ACTG 5202.  A comparison of four different treatment regimens in treatment-naive patients.  It is not a clinical trial (all of the drugs currently have FDA approval for HIV therapy) as much as a clinical study, to see which of the four regimens works the best.

Clinical trials, for some reason, just love to use the abbreviations of these drugs, rather than the trade names we all know them as, which only serves to confuse, and sometimes scare off, potential participants.

The four regimens being compared in this study are:

Truvada + Sustiva = TDF/FTC + EFV

Epzicom + Sustiva = ABC/3TC + EFV

Truvada + Reyataz (boosted with Norvir) = TDF/FTC + ATZ + RTV

Epzicom + Reyataz (boosted with Norvir = ABC/3TC + ATZ + RTV

Essentially, they are comparing two Nuke/non-Nuke combos against two Nuke/PI combos.

Now, whether or not you choose to participate is up to you.  You would be randomized into one of the four arms.  You will take the study drug PLUS placebo tabs made to look like the other study drugs so you won't know which regimen you are on.  You should decide if you would be willing to take any (remember, you don't get to choose, it is chosen for you) of the four combos and, if so, then you might choose to participate. 

If you participate, all your labs and meds would be provided for two years, most likely to be increased to four years.  I don't know your financial or insurance situation, but that might be worth something to you.

I myself am currently in a clinical study.  Not this one, though it was offered to me.  I chose to participate in a different study but if I had it to do over again, I would probably choose this one.  20/20 hindsight, huh?

Anyhow, if you have any questions feel free to PM me.

-Whizzer

Offline ibacowboy2

  • Member
  • Posts: 4
Re: Clinic Trials or Not?
« Reply #4 on: March 14, 2007, 06:38:34 PM »
whizzer is kinda correct. i was ineligible for the randomize test that either treated or didn't treat, my virals where to high. The other i would be randomized into 1 of 4 groups. some of the drugs where kinda scary and in all 4 groups there is a drug or a placebo that's blinded to me and to my doctor. I also have to either take a minimum of 3 pills daily or 5 pills daily depending on the group I'm assigned too. My normal doctor would be prescribing Atripla which is one pill once a day. I guess my thinking is that my life has already been turned upside down and i think getting things under control and a little back to normal would be nice. Hence i think i would rather stare at one pill a day instead of 5. however I'm feeling kinda guilty about it.

Offline stpetecoyote

  • Member
  • Posts: 25
  • me
    • QueerCoyote.com
Re: Clinic Trials or Not?
« Reply #5 on: March 15, 2007, 03:04:12 PM »
Clinical trials are not the only way to help.   Don't feel guilty for doing what is best for YOU!   For some people clinical trials might be a good opportunity,  as someone that is also new and still on quite a roller-coaster some days...I would probably opt for something that has been tested and accepted unless my Dr could convince me of the potential benefits and the risks are very clear.  Good luck with whatever your choice is!
When we killed what we were to become what we are, what did we do with the bodies? We did what most people do; buried them under the floorboards and got used to the smell - Jeannette Winterson


02/05/07 CD4 264  24.0% VL ??.?
03/05/07 CD4 ???   ??.?%  VL 825  
03/22/07 CD4 355  27%    VL 1232
04/24/07 CD4 490  28%    VL 3785
07/26/07 CD4 368  23%    VL 8900
08/31/07 CD4 454  23%    VL 2200
10/29/07 CD4 474  24%    Vl  18800
Started Atripla...been VL Undetectable and CD4 around 400 Ever Since

Offline fearless

  • Member
  • Posts: 2,191
Re: Clinic Trials or Not?
« Reply #6 on: March 15, 2007, 07:50:27 PM »
Firstly, it's your decision, 100%. You have to do what you believe and feel to be the best thing for you. It's your life and your body. And, don't feel guilty, no matter what decision you reach.

Clinical trials are important, but they are not everyones cup of tea. There are always risks associated with trialling new treatments. Essentially, you are a human lab rat. But, we need people to participate in trials in order to test and bring new drugs onto the market.

I participate in a trial for the treatment naive. It's an open trial, so we all know what we are getting. I was randomised into the control arm (Kaletra and Truvada). The new drug was what I know as TMC-114 (I think it is now approved in the US as Prezista, or something).

I participated for a few reasons:
1. I was already going to commence treatment with Kaletra and Truvada. My doctor recommended Sustiva and Truvada, but the night time dosing on an empty stomach and unknown possible effects on another illness I have made me wary.
2. TMC-114 had already been through phase 1 and 2 trials with treatment experienced patients with good results.
3. The trial drugs were free saving me nearly $2,000 a year in co-pays.
4. I'm a scientist by trade, and kinda liked the idea of being a lab rat. There are extra doctors visits involved, especially at the beginning, with lots of tests even before you are accepted to the trial. If you have any other serious conditions, you probably will not be eligible to participate. Doctors visits usually take a couple of hours, as they prod, poke, measure and weigh a whole bunch of things each visit for the trial.
5. I don't have a lot to lose. I'm a single gay man, with no kids or the like to leave behind. Trials are important, but if I had a wife and kids to think about, I'm not sure I'd participate.

I don't regret it at all.

It's up to you. Choose what is right for you.
Be forgiving, be grateful, be optimistic

Offline Jnm594

  • Member
  • Posts: 111
  • Fight! Fight! Fight the Good Fight!
Re: Clinic Trials or Not?
« Reply #7 on: March 16, 2007, 01:10:53 PM »
I am actually in the study that Whizzer talked about and the my experience has been great. Not to mention the meds have saved my life (I started with cd4 of 15 and vl in the millions and went undetectable after 5 months and three months ago my cd4 was up to 155). I just went on Tuesday for my three month blood work and was given a bag with $11,676(retail at Walgreens.com) worth of meds for the next three months. There is no way I could afford these on my own and am not on any type of disablity and cant get any assistance because I made too much last year. I'm one of those lucky ones that is caught in the middle.  :-\ :-\

Now I figure that if I had to pay for these myself that would be $46,704 in meds alone for a year not even considering doctors, labs, supplements and then the other insignificant things like food, shelter, etc....So my decision was more financial than anything but my doctor at the time told me that he would start me on one of these groups anyway so there wasn't a lot of thought process involved.

Remember that studies do NOT replace your primary care or your doctor. They are interested on your adherence and what your results are....They are not your doctor!!!

But that was right for me. You should talk to your doctor about the different pulses/minuses, what they reccomend, etc. Just get all of your information before you make a decision.

Remember this is all about what is best for you, don't ever forget that!

When it gets hard I always listen to my favorite song of all time..........

http://www.youtube.com/watch?v=qJEYu3KgWCE

Offline J.R.E.

  • Member
  • Posts: 6,960
  • Joined Dec-2003 Living positive, since 1985.
Re: Clinic Trials or Not?
« Reply #8 on: March 17, 2007, 01:30:45 AM »
Hello,

I have never been involved with clinical trials as far as HIV medications go. I am currently involved in a clinical trail for PN, which I don't regret getting involved in.

If I was given that opportunity, I would involve myself in a clinical trial for meds.


My next possible clinical trial, is testing a vaccine for HIV positive people for small pox.. I need to talk with my doctor on this. to see if my numbers are physically up for this one.  ::)

My partner was also asked, if he wanted to participate, because this trial needed an HIV negative person also. so, we'll see what happens.


Ray
Current Meds ; Viramune, Epzicom, 40mg of simvastatin, 12.5mg 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


 In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started my first  HAART regimen  on October 24th,03.

 As of DEC 9th, 2013,  t-cells are at 437 Viral load  <40 .

 Current % is at 16% (L)

  
 62 years young.

Offline J.R.E.

  • Member
  • Posts: 6,960
  • Joined Dec-2003 Living positive, since 1985.
Re: Clinic Trials or Not?
« Reply #9 on: March 17, 2007, 07:01:13 AM »
Hello Cowboy,

I had meant to put this up earlier for you, but I slipped. From the Aidsmeds lesson section the

following :


http://www.aidsmeds.com/articles/ClinicalTrials_10673.shtml



Ray
Current Meds ; Viramune, Epzicom, 40mg of simvastatin, 12.5mg 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


 In October of 2003, My t-cell count was 16, Viral load was over 500,000, Percentage at that time was 5%. I started my first  HAART regimen  on October 24th,03.

 As of DEC 9th, 2013,  t-cells are at 437 Viral load  <40 .

 Current % is at 16% (L)

  
 62 years young.

 


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