Meds, Mind, Body & Benefits > Research News & Studies

Study of NGX-4010 for HIV related neuropathy

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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.:

--- Quote from: cwd11 on January 29, 2007, 05:32:04 PM ---Is your neuropathy due to the meds or the virus?

--- End quote ---


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.  :o  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

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