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Clinic Trials or Not?

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ibacowboy2:
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

megasept:

--- Quote from: ibacowboy2 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

--- End quote ---

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

Central79:
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.

whizzer:
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

ibacowboy2:
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.

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