Protocol changes?!?!?!

JanethePain · Post by **JanethePain** » Thu Apr 24, 2008 6:18 am

I'm telling you kids that sometimes I think Opexa has a secondary "mission" to confuse us into flares. No kidding!

I'm just about ready for that Visit 52/0 excitement a few of you have already done (May 1 for me). Those of us who have already gotten the paperwork should pretty much be able to swear that the second chunk looks a whole lot like the first chunk only with fewer MRIs.

Then comes this weekend! UGH!

Came down with a massive UTI and was on the verge of a panic attack knowing, absolutely *knowing* that a round of antibiotics would delay this visit 30 days past the last pill-swallowing.

Right?

Not at all! I'm still on track for May 1, even though I won't be finished with my meds until this Saturday morning!

I was so troubled by this "news" that I went through the new paperwork again to clarify the antibotics/steroids stuff. Looks to me exactly like the stuff we had for the first part of the study: 30 days wait after antibiotics, 60 days wait following steroids.

But I just got an e-mail from my coordinator, (quote) "... I e-mailed Opexa and they are assuring me that antibiotics will not affect the MRTC blood draw. We need to maintain your visit schedule."

I AM SO CONFUSED!

Any clues why things are different for the second half of this study?!?!?!

Bothered and definitely bewildered but not bewitched (at least to my knowledge...)

JanethePain · Post by **JanethePain** » Thu Apr 24, 2008 6:20 am

.. and I swear that if they DON'T find my MRTCs in this blood draw and tell me to wait 90 days, I'm going to be very angry. "You won't like it if I get angry."

ssmme · Post by **ssmme** » Thu Apr 24, 2008 6:38 am

Do you think it's only prior to the procurement that you have to be off the antibiotics. I haven't paid attention to that detail specifically but I have a bit of chest congestion (I'm sure one of my kids brought it home from school) and am just suffering through w/o going to my gp because I know he will prescribe a z-pack and I'm awaiting the phone call from LifeBlood about the procurement. I do not want to cause a delay.

BTW I get frequent UTI's also and am praying that I can keep from getting one till procurement is done. I guess I better drink a lot of cranberry juice. It's supposed to keep the kidneys and connected pipes well cleansed.

If you hear differently about the mrtc's and abx please let us know.

Marcia

Loobie · Post by **Loobie** » Thu Apr 24, 2008 8:31 am

Marcia,

I have major bladder issues and I swear by Cranberry juice as I've never had a UTI. KNOCK, KNOCK (that's me rapping on the wood). I must literally drink a gallon or two of cranberry juice a week. I have a monster glass in the AM and then also at dinner. So I think there may be something to the cranberry thing.

av8rgirl · Post by **av8rgirl** » Thu Apr 24, 2008 9:33 am

I was also told that antibiotics do not have an effect on MRTCs. I was on antibiotic therapy for a killer sinus infection from mid December til end of January. And there was no change in any of my appt scheduling. The only appt scheduling that I had changed was when I had an exacerbation last July and they had to change my vaccine appt and move it out 30 days from the IVSM infusion.

Other than that, no other changes.

I've just signed and read all the protocol for the extension study and I agree Jane, no changes other than the fewer MRI changes. Nothing to do with meds...

I am currently having IVSM for an exacerbation which will change things for me as I will now have to resign the consent forms to re-enter but since I tested negative for MRTCs on the initial blood draw, it won't have any effect on the 90 day wait.

For those of you who have frequent UTIs, here's a bit of advice...start taking an OTC product called AZO yeast. It's wonderful!! And Opexa does not have a problem with it. I was also in the frequent UTI category and cranberry juice just wasn't kicking it and I can't take a lot of the antibiotics to treat. My Ob/gyn recommended this product and I've been on it for 2 years and NOT ONE UTI...it's a pill. Take one a day. And it's cheap. You can get it at Wal-Mart, Target, any drug store. I think it's $5 for 90 days.

ssmme · Post by **ssmme** » Thu Apr 24, 2008 10:13 am

start taking an OTC product called AZO yeast

What is it? I have a medical "condition" where my right kidney has dropped. Supposedly due to my triplet pregnancy. They urologist said that it might pop back up on its own (but what in a woman's body goes up!!!??!! Laws of gravity are harder to overcome in my understanding). This keeps the urine from draining properly and is the cause of most of my problems. How does AZO work? If it might help I'm all for it but I never heard of it before.

Marcia

flipflopper · Post by **flipflopper** » Thu Apr 24, 2008 1:09 pm

Jane,

I was on minocycline (an antibiotic) before I joined this trial. At my first screening visit, I tested negative for MRTCs. I decided to stop taking some of the supplements I was on and I also stopped taking minocycline. I tested positive for MRTCs on my second try (I still have no idea if making these changes had anything to do with testing positive the second time). I didn't go back on minocycline right away. While I was still in the phase IIb trial, I asked the trial coordinator if I could go back on minocycline and she told me it wasn't a problem. I don't think that antibiotics in general were to be avoided during the phase IIb trial.

Now, since I haven't posted here in a while, I will give a brief update. I had no new relapses (since the last time I posted) and my EDSS is back at 3 (what it was when I first started the trial). My level of fatigue is even worse than it was last year however. That symptom is just killing me!!! I was suppose to have my last appointment of the phase IIb trial this week but it was pushed back by 1 ½ week.

av8rgirl · Post by **av8rgirl** » Thu Apr 24, 2008 6:09 pm

ssmme wrote:
start taking an OTC product called AZO yeast
What is it? I have a medical "condition" where my right kidney has dropped. Supposedly due to my triplet pregnancy. They urologist said that it might pop back up on its own (but what in a woman's body goes up!!!??!! Laws of gravity are harder to overcome in my understanding). This keeps the urine from draining properly and is the cause of most of my problems. How does AZO work? If it might help I'm all for it but I never heard of it before.

Marcia

http://www.azoproducts.com/ is their website. AZO yeast is the product I take daily and have for over 2 years. I mispoke before about frequent UTIs...I used to get them, as well as frequent yeast infections from frequent IVSM infusions. Since starting this product, which was recommended by my ob/gyn, I have not had one UTI or yeast infection and I have had several IVSM infusions. In fact, I am on day 2 of a 3-day IVSM infusion.

I hope this information helps. I would talk to your doctor or the pharmacist.

I can't take many of the abx drugs for tx of yeast or UTIs and I am allergic to sulfa drugs and to the cycline family as well as mycine family of drugs...so I am sort of limited when I get infections!

JanethePain · Post by **JanethePain** » Fri Apr 25, 2008 6:01 am

ssmme wrote:... BTW I get frequent UTI's also and am praying that I can keep from getting one till procurement is done. I guess I better drink a lot of cranberry juice. It's supposed to keep the kidneys and connected pipes well cleansed... Marcia

The only thing I can add to this (besides MUCH sympathy and a "why us" outcry) is a little info from my primary care guy who told me that there's an old-fashioned product called (spelling alert) Urised/-cept/-sept (??) that isn't an antibiotic but a urinary tract antiseptic. Might be worth a look just as something to use occasionally, I guess. The only downside is that it turns the urine bright blue... I guess that combined with the pyriddium should be quite a rainbow... ugh!

JanethePain · Post by **JanethePain** » Fri Apr 25, 2008 6:03 am

Loobie wrote:Marcia,

I have major bladder issues and I swear by Cranberry juice as I've never had a UTI. KNOCK, KNOCK (that's me rapping on the wood). I must literally drink a gallon or two of cranberry juice a week. I have a monster glass in the AM and then also at dinner. So I think there may be something to the cranberry thing.

And this is probably SO much better for us now that we can get 100% juice and not the measly 10% or so that used to be mixed up with apple or grape to sweeten it! I rather like that sharp taste myself! And I'm seriously considering making it the ONLY beverage these days, too... and I'm such an unsweetened iced tea addict that this is gonna be hard going...

JanethePain · Post by **JanethePain** » Fri Apr 25, 2008 6:06 am

av8rgirl wrote:... I am currently having IVSM for an exacerbation which will change things for me as I will now have to resign the consent forms to re-enter but since I tested negative for MRTCs on the initial blood draw, it won't have any effect on the 90 day wait...

Please get better soon, Cheryl, and THANKS for the supplement advice; it's on my grocery list for today!

JanethePain · Post by **JanethePain** » Fri Apr 25, 2008 6:11 am

flipflopper wrote:... Now, since I haven't posted here in a while, I will give a brief update. I had no new relapses (since the last time I posted) and my EDSS is back at 3 (what it was when I first started the trial). My level of fatigue is even worse than it was last year however. That symptom is just killing me!!! I was suppose to have my last appointment of the phase IIb trial this week but it was pushed back by 1 ½ week.

I know what you mean about that fatigue! From Christmas until March, I wss spending 3-4 days a week in bed with NO energy at all. At my March appointment, my neuro prescribed Amantadine--and while it hasn't restored me to pre-MS levels by a long shot, I'm happy with the 80% more energy. It gets me through me day--slow, to be sure, but much more productive.

ssmme · Post by **ssmme** » Fri Apr 25, 2008 10:12 am

and I'm such an unsweetened iced tea addict

Me too!!! I thought I was the only one. I don't even do lemon in my tea. I like lemon but I'd rather eat it raw or squeezed on my fish. In the hotter months it's all I drink except for the occasional glass of wine. My dentist put the little movie camera in my mouth to show me my tea stains. I told her I pay her to clean my teeth so if I drink the tea then I'll keep her in business. Nothing comes between me and my tea.

Marcia

av8rgirl · Post by **av8rgirl** » Fri Apr 25, 2008 6:18 pm

ssmme wrote:
and I'm such an unsweetened iced tea addict
Me too!!! I thought I was the only one. I don't even do lemon in my tea. I like lemon but I'd rather eat it raw or squeezed on my fish. In the hotter months it's all I drink except for the occasional glass of wine. My dentist put the little movie camera in my mouth to show me my tea stains. I told her I pay her to clean my teeth so if I drink the tea then I'll keep her in business. Nothing comes between me and my tea.

Marcia

I drink a lot of iced tea (unsweetened) and coffee. The lady who cleans my teeth does the same thing...you know if that's the ONLY problem I have with my teeth, then I can live with that! Considering that I am on Topamax which has a side effect of gingivitis and with all the IVSM I've had over the last 7 years...I consider myself lucky that I have good teeth...

On the fatigue issue, I take 400 mg of provigil a day along with drinking 3-4 cups of coffee a day...and still battle fatigue.

Thanks for the well wishes on getting over this exacerbation. It's pretty bad...I think that the last two I have had have been pretty intense, much more so than in the past. But less frequent...that I can handle.