Study of NGX-4010 for HIV related neuropathy

[J.R.E.]

Hello,

You have probably been seeing this ad flashing on the pages :


http://clinicaltrials.gov/ct/show/NCT00321672?order=1





This is the study I will be involved with next week. I had mentioned this a while back.


Ray

[cwd11]

Is your neuropathy due to the meds or the virus?

[J.R.E.]

Is your neuropathy due to the meds or the virus?

Hello Cwd,

The doctor believes the neuropathy was/is a result of the virus. I was 17 plus years into HIV before I began treatment. I also started treament with 16 t-cells and a viral load 500,000 plus. Neuropathy started about 4 or 5 months after treatment was started.

My appointment ( for the Capsacin study) is Febrary 5th. At that time I will have a physical and an ECG. The doctor informed me, to have someone with me on that day, Just in case I have a bad reaction to the patches,( they won't let me drive)... If that is the case, the doctor informed me, he will give me a narcotic for any pain, associated with the patches. Haven't had a good narcotic in 35 years !




Take care------Ray

[cwd11]

Neuropathy was one of the first symptoms that I had HIV.  Went to the doc about loosing feeling in my feet.  Months went by, the feeling turned to fire, and the doc just scribed more vicodin.  Eventually he put two and two together and I was diagnosed HIV (6/97) after losing 45 lbs.  TC 11, Vl >1,000,000.  After two years on vicodin, was weened off and put on Neurotin (hate the stuff...lost three years in a fog).  Normal dosage 300 mg/daily; was up to 3000 mg/daily.  Am currently on Ultram 8 X 50mg daily.   Let me know how your trial goes.

[J.R.E.]

Hello Everyone,

I've decided to use this thread, to keep everyone updated On the NGX-4010 Study , that I am involved in.

I have had a long day today. My screening visit/ appointment with my doctor, and Donna, of Clinical Research of West Florida, Inc., took place around 10:45 this morning. I was really rushing this, thinking that I was going to have the patches placed on my feet today, after the physical, but that was obviously not the case. I have never been in a study, so this is all quite new to me.


After a detailed explanation of this study from Donna, And after agreeing and signing 13 pages of " Informed Consent to participate in a Clinical Research Study", Today was basically some pre-blood tests, and a complete physical, including a ECG. All my current medications were discussed, also the current vitamins and supplements that I am taking were discussed. I am glad that Ed was with me today. After working last night, I was tired, so I wanted to make sure that any information I missed, Ed got !! All the painful areas of my feet, were examined and checked today.  The total time today spent at the doctors office, was about 2 hours 15 minutes. I was given a diary, that I have to fill out daily, starting today( Feb 5th,07) and ending 28th of feb,07.

This study is of course voluntary, and I may withdraw from this study at any time, for any reason. There is no guarantee that my health will be benefited, by participating in this study. If I choose not to be in the study, I will not lose any medical benefits, and can still participate in future studies.


The 13 pages of consent forms contains information about the study, explains the risks of being in the study, and explains my role and responsibilities as a participant. I have got to go through these documents a little more tonight. I am much more alert now, then what I was this morning.


There will be 480 participants in this study. This is in phase 3 of the Capsiacin study.  329 participants will have the high concentration patch ( by chance) and 160 participants will have the low- concentration patch.


My participation in this study, will last about 14 weeks. There will be a total of 5 scheduled visits to the study doctor's office during the study. First one was today. Next visit will be the patches being placed on my feet. I will come in at 4,8 and 12 weeks after my initial visit ( which was today). I will also be contacted over the phone throughout the study, to see how I am doing.. I will have no idea, which patch I will be on.

Donna, will be contacting me, in a couple of days. At that time I will be given the date, as to when the patches will be placed on the feet. My first thought, was that these were going to be small patches, but this is not the case.    From what I was told, these patches will surround the entire foot. In my case, up to the ankle !!


I will give more information later., But I got to get moving here. Time to get into the shower, and get ready for work tonight !! I was very impressed with the way things went today !



Ray

[J.R.E.]

Update  2/12/07

Donna, from clinical research called me early today, to ask me if I was keeping up with my diary. I told her yes.

She then told me she would colllect that information from me this Wednesday, and that the patches would be put on, in the doctors office 8:00 Thursday morning.


She called back later in the day, after conferring, with her staff, decided I do not have enough days completed in the diary to start with the patches. A few more days are needed to evaluate my  pain measurement.

So, it looks as though, sometime next week, for the patches on the feet.



Ray

[J.R.E.]

Update 2/20/07

Donna, from clinical research called today and I gave her the necessary info,from the diary I've been keeping these past 15 days.

My appointment is set up this Thursday the 22nd, at 8:00 Pm. I was told to expect staying at  the doctors office no later then 5 hours and no less then three. I keep having these illusions of hobbling out of the doctors office with big ole clowns feet, after the patches a re placed on.   Ed will be driving me, just in case.

I hope it's not too uncomfortable though, I still have to go into work Thursday night. I wasn't planning on taking the night off.

The only prep I have to do, is to shave my feet !!   I am not too neanderthal down there !! ...
 Now, if I had to shave my chest, that would be a different story !! I will probably update this Thursday evening, before I go to work.... depending on how tired I am.



Ray

[J.R.E.]

Update 2/22/07


Had a very difficult day today at the doctors office.Spent 4 1/2 hours there. I will post more tomorrow. Had the patches placed on both feet today, and I got to tell you all, It was probably one of the most painful things I have experienced, since my severe epsisode of shingles, back in 1989.( I am not really complaining though--but, it was much more intense then I imagined it would be. Since 10:30 this morning, I have taken 3 Oxycodone. The pain from these patches has been incredible. Right now it's not to bad. I do have to go into work at 11:00 tonight, should be able to pull through the night. the Patches were applied for 60 minutes. I don't know which strength patch they used.




Later------Ray

[J.R.E.]

Update Friday 2/23/07,


Its been a pretty tough past 24 hours !!

I will summarize the events of the past 24 hours:


After a month or so, of talking about this trial on the Capsaicin patch. I went to the doctors office yesterday at 8:00am to meet with the doctor, and Donna, from West Central Florida, Clinical Research.


At 8:00 am I made myself very comfortable in a reclining chair in one of the rooms at the doctors office.

Donna came in first, ( I removed my shoes and socks, and Donna proceded to wash my feet.) I told her they were not not really that dirty, as I wash them once a week whether they need it or not  . So we started off with a chuckle...


After My feet were washed, my doctor came in to examine them to make sure there were no open sores, and to just give them a visual inspection. Tuning fork was used again.

At that point, Donna came back into the room, and applied a numbing agent to cover both feet. Included tops, bottoms toes, between the toes, right up to the ankles.

This numbing agent stayed on for ( I believe ) about 30 minutes. During this time, my temp and blood pressure was taken. Also had two more vials of blood taken. These will be used( Iwas told) for viral load and t-cell count.

We had discussed the results of the ECG, and the blood tests ( for this study) from February 5th. There was no viral load or t-cell count taken on Feb 5th. It was the basic round of blood test. Those test came back excellant. They had mentioned to me how pleased the were at those results. Everything was within range. I , of course viewed the test results, just to verify what they were telling me !! The ECG was also very good, no problems were indicated, and everything appears very normal.

The numbing agent was removed, and the feet were washed one more time. At this time My doctor came back in to the room, and started drawing lines on my feet with markers, so that the capsaicin patches could be properly cut to shape, to cover the entire foot.


The patches themselves, were about 6 inches by 8 inches.  With the NGX 4010 study numbers imprinted on them. I had no idea which patch I was going to receieve. The high potency one, or the half potency one. It was determined at this time, when the patch kit was open, that I would receive the 60 minute patch. The patches come with a backing that is pealed off.

After the patches were cut to shape, they were then placed on my feet. Left foot first. Took about 3-5 minutes for the patches to be placed on each foot. They also do not adhere to well to the skin, so gauze was gently wrapped around the patches, making sure of full contact with the foot. The entire foot, from ankles doen were covered.


THEN THE FUN BEGAN !!


Approx 10 minutes into having the patches on, I felt the heat being generated in my feet. The were continually monitoring my blood pressure during this time. and asking me my level of pain.

30 minutes into the patches, I looked over at Ed, and said "This is really getting to be quite painful. I let the doctor know, how much pain was occurring. On a scale of 1 to 10( ten , being the worst) I was ranking it about an 8...... Now, I usually take pain pretty well !! But I was beginning to wonder at this point. 


About 35 minutes into the patch, I didn't think I could take much more. The doctor then gave me some Oxycodone. The pill started working in about 10 minutes, but was not really helping very much.

About 45 minutes into the patch, I was now rating the pain at a full 10

55 minutes into the patches, I asked for another pill. They asked me if I wanted to stop the study, I said no... lets keep going, there's only 5 minutes left ( a very long five minutes)

My blood pressure at this point was now 172 over 101. I never have high blood pressure, and my blood pressure has always been fine these past three years and 4 months on meds. So, I was quite surprised to see it go that high.


After 60 minutes. the patches were removed. The pain pills were somwhat effective, but not all that much. The feet were very sensitive. They were twitching. The slightest air movement on them, felt like fishing hooks going into my feet. The feet were extremmely red in color. They did not swell up, or blister although they sure as hell felt like it. The tops of the feet, and the toes, were the most painful. The bottoms of my feet, which I have most of the pain in, felt pretty good.

Shortly after the patches were removed, the feet were again washed. By this time, the pain pills had kicked in, but it still required a lot gentleness in touching the feet. There were several more blood pressure tests done, and the blood pressure started coming back down to normal again.

I stayed another hour in the office for obsevation after the patches were removed. By the time, we were able to leave, the pain medication certainly did it's job. The time now was 12:30 Pm. I was able to put on socks ( that were given to me at the doctors office) And I was able to  get my feet back into my sandals with no problems at all. I was able to walk with very little problem, back to the car. We then left the office and started home.


About 2:00 pm the pain level went back up to 10 !! I had only taken at this point, the two pills that were given to me at the doctors office.

I started filling the bathtub up with water.Cooling water seemed the only option at this point.The pain was getting excrutiating, I had to do something. The water had to be just the right temperature-- too cold was too painful, and too warm was too painful. The minute I place my feet into the the water, the pain  immediately subsided, and it felt good. After removing the feet from the water, the pain started almost instantly. I was tired and wanted to sleep, right there at the bathtub, with my feet soaking.

At that point. I couldn't take it anymore, so I took another pain pill. I also took some Vaselline intensive care lotion, and covered my feet with the lotion. ( This seemed to help a lot, and was soothing)

That pain pill then kicked in, and I was able to sleep from about 3:00 pm until, about 8:00 pm. I had a good sound sleep.

THEN I HAD TO GO TO WORK

I woke up and felt pretty good. took a shower, there was still some tenderness, when the water would hit the feet., But overall not to bad. I was debating calling into work sick, but I thought I would tough it out. The feet wwere back to normal color.

By the time I got to work ( around 10:15pm ) the pain was back up at around the 9 level. I was barely able to walk. But I covered it up pretty well, where no one really noticed.


I punched in at 11:00 pm got behind the desk, the first thing I had to do was remove my shoes. The pain was still very intense.


After the shoes were removed, the pain levels went down considerably, and also quite rapidly, and I was able to get through the rest of the night, with very little problem I had gotten by at this point with just the 3 initial pain pills.

I refilled the pain prescription at the pharmacy on the way home from work this morning. But have not used any of those, and I still have one remaining from what the doctor gave me.

Any pain pills taken have to kept in the dairy that I have. The time, and the level of pain, are monitored.

I was given another dairy to maintain until my first follow up visit on 3/22/07.

Clinical research also will call me periodically, to see how things are going. I will get the first call from them, This coming Monday morning.

As I sit here at the computer, things are going pretty well. We had just come back from going out to dinner. I had to kick the shoes off in the car, to be comfortable, but overall not too bad.

I think I would put my pain rating ( at this moment) at about a 5. If it stays about like this, I shouldn't have to take anymore pain pills. I don't like taking them anyways. The 3 I took yesterday, came pretty close to making me heave up. But I ended up OK.



Thats it for now------Ray

[J.R.E.]

Update 3/5/07

I guess it's been 11 days, since I started the trial/study, with the capsaicin patches. A
brief follow up...

My feet are doing pretty well. I am at least able to stand on them now, for more then an hour with no excessive amount of pain !! I have no difficulty walking. And I haven't had any need to take the pain medication.

I would say that overall ( at this point) I am about At the same level of pain or discomfort, that I was at, prior to the patches being placed on the feet on 2/22/07


My next follow up visit will be March 22nd...



Ray

[mjmel]

OMG. What an ordeal! I sure hope you keep updating your post. I find your detailed accounts very interesting reading. And painful.

[J.R.E.]

OMG. What an ordeal! I sure hope you keep updating your post. I find your detailed accounts very interesting reading. And painful.

Whats the saying.... No pain no gain !!    Hangin in there !! Got to !


Ray

[J.R.E.]

Update 3/22/07


I just got back from the doctors office this morning. This was my 4 week follow up, since the capsaicin patches were placed on my feet.

The visit was brief today. Blood pressure was taken, along with temperature. No blood tests were done today.

I filled out a questioner, asking about pain levels, since my last visit four weeks ago. I was given a new "pain medicine and pain diary booklet".  I am about at the same pain/discomfort level, slightly less, then where I was prior to the patches. Overall things are going well. Still not on any pain medication for the PN.

The doctor examined my feet, didn't notice anything unusual.The next follow up appointment date is April 19th. I was scheduled to have my normal blood tests on the 13th of April, so we decided to schedule both visits on the same day. ( save me one trip to the office)


Ray

[J.R.E.]

Update 4/19/07


Not much to report on this update . This visit today, was the 8th week follow up, into the capsaicin study. The doctor once again, examined my feet, and found nothing unusual.

I handed over my diary, that I have been keeping daily. There were also a few more additional pages of questions regarding pain levels, since my last visit, that I had to fill out in the  office. Was also given a new pain management booklet, that will take me to the final day of this study.

Overall, I haven't had any noticeable relief, in the PN since the study began. It has not worsened, but it has not gotten any better. Has  remained about the same, since my last visit.


The final visit for this study will be on May 16th, 07 . About 4 weeks from today.


Also had my blood drawn, for my quarterly labs, and will get those results in 10 days or so.



Ray

[frenchpat]

Ray,

I just read your posts and I must say I find you very brave to do this. And as one who might suffer from PN in the future I thank you very much for looking into solutions to it.

I hope you will benefit from this research.

Pat

[allanq]

Ray,

That's quite an ordeal you've been through. Thanks very much for documenting it for us. I had been thinking of joining a similar study in the Bay Area. I've had neuropathy for 11 years. I'm pretty sure it is drug-related, since I had taken ddI and d4T (at separate times) during the two years prior to the onset of symptoms.

Has the study doctor indicated about when you could expect some relief from the PN? Is the relief supposed to occur as soon as the pain from the capsaicin wear off?

Assuming that this treatment works, is it something that would have to be repeated periodically? (I hope not!)

Again, thanks very much for telling us all about your experiences.

Good luck,

Allan

[J.R.E.]

Ray,


Has the study doctor indicated about when you could expect some relief from the PN? Is the relief supposed to occur as soon as the pain from the capsaicin wear off?

Assuming that this treatment works, is it something that would have to be repeated periodically? (I hope not!)

Good luck,

Allan

Hello Allan

This was just a one time thing. Since this was only a study investigating the capsaicin, there were no guarantees.
I was told in the beginning that if I would have some relief, that it could last anywhere up to three months. But, I haven't had any noticible relief. I am at the same pain levels I was at prior to the patches.


I don't think I would want to repeat his one again. If I did, I would have to take at least two days off of work, just to play it on the safe side. 

I still believe, I had the most potent patch placed on my feet. Some of the other people in this study, did not have anywhere near the pain that I had. Some did not require any pain medication, while the patch was on their feet. Plus, I had the one hour patch. Some on this study had the thirty minute patch.

Who knows what they will discover, through this study. Somewhere down the road, there could be some ointment that you put on your feet for the PN.



Ray

[milker]

Ray,

thank you so much for taking so much pain upon yourself to help others. It sure did sound very painful. 

Milker.

[J.R.E.]

Ray,

thank you so much for taking so much pain upon yourself to help others. It sure did sound very painful. 

Milker.

   It only hurt the first 24 hours, after that it was no big deal !!



Ray

[milker]

   It only hurt the first 24 hours, after that it was no big deal !!



Ray

You're obviously not a weenie like me 

[allanq]

After I developed PN in 1996, my doctor suggested that I try using over-the-counter capsaicin. I bought a tube at my local Walgreen's and put it on my feet at home. I then left the house to meet a friend to go to a movie. About 15 minutes into the movie, I thought my feet were on fire. I left the movie, went back home, and thought I could wash the stuff off with cold water in the bathtub. But it must have already been absorbed, because the burning from the capsaicin lasted a whole day. Afterwards, the PN pain remained.

Allan

[J.R.E.]

After I developed PN in 1996, my doctor suggested that I try using over-the-counter capsaicin. I bought a tube at my local Walgreen's and put it on my feet at home. I then left the house to meet a friend to go to a movie. About 15 minutes into the movie, I thought my feet were on fire. I left the movie, went back home, and thought I could wash the stuff off with cold water in the bathtub. But it must have already been absorbed, because the burning from the capsaicin lasted a whole day. Afterwards, the PN pain remained.

Allan

Yep, I hear ya !!! As I stated  in an earlier post, I only felt comfortable by keeping my feet in cool water. That was until I swallowed another pain pill !!    It doesn't wash off !!!...


Ray

[J.R.E.]

Donna, from Clinical research called today.( 5/11/07) Asked how things were going. I said pretty good. I read off to her the pain levels ( from the daily diary I keep) -- since my last vist.

She reminded me of my appointment this coming Wednesday, May 16th. I think this is the end of the study, I have to recheck. There still may be one more follow up in four weeks.

I will keep you updated next Wednesday.


Ray

[J.R.E.]

Last Update !!


This will be my last entry /update, as today officially concluded my trial of the capsiacin study. I thought I had another 4 weeks to go, but this was it today !


The office visit lasted about 1 hour and 15 minutes this morning. It started off with me handing to Donna, my daily diary, that I have been keeping since my last visit.

I then proceded to fill out another 6 page questioneer, regarding pain levels, since my last visit.

We then had a good conversation on upcoming studies, that I may be contacted for. I told Donna to please feel free to call me. I would be happy to participate as long as my doctor gives the go ahead. She then handed me a check for $275.00 for my participation.

I was disqualified from the smallpox study, because I already had the smallpox vaccine. Oh well !!

There are plenty of studies going on.


After this discussion, I was given another ECG, which came out very well. They also withdrew about 7 vials of blood. Included in these tests, will be t-cell and viral load and complete liver panel.There were one or two other test being done, can't remember what it was though !! My feet were also rechecked, by my Doctor, for anything abnormal.
 Donna told me she will mail me those results when they become available. My blood pressure is/ has been running high since this study began. My blood pressure today was 178 over 95. Pulse was at 78. I will have to keep an eye on the blood pressure, and see if that may come back down again. It may be something totally different that is making the blood pressure go up. My blood pressure was always fine prior to this study.


She has had some good results through this study, with some that participated. I don't regret involving myself with this study, even though I didn't have any favorable results.. But it has been an experience !!

I will be curious as to those blood tests results when they come in. My next appointment with my doctor will be for blood tests will be August 15,07

EDITED to add, I also gave a urine sample for testing today.


Ray