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Author Topic: JUST FIVE MORE PARTICIPANTS NEEDED!!!  (Read 3728 times)

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Offline emeraldize

  • Member
  • Posts: 3,353
JUST FIVE MORE PARTICIPANTS NEEDED!!!
« on: November 24, 2006, 05:49:25 PM »
There is a current double-blind NIH study for which they are now recruiting the 13th of a total of 18 subjects needed. The purpose of the study is to evalute the effect of leflunomide, an immunomodulatory drug (that can fine tune the immune system), on the life cycle of CD4+ T cells in persons infected with HIV. Leflunomide (also called Arava)is a drug which has been approved by the FDA for the treatment of rheumatoid arthritis. It works by blocking the cell division of activated T cells. In HIV infection, the HIV virus causes increased activation of T cells. Activated CD4+ Tcells become more easily infected by HIV and die. If an immunomodulatory  drugs such as leflunomide coud be used to block the cell diviion of activated T cells, it could decrease the number of cells that die becuse of continuous division and also decrease the cells in which HIV can reproduce leading to a lower level of HIV virus in the body. This is the basics of the study---of course, there is more text. Here's the criteria: be between ages of 18 and 65; have HIV infection;CD4+ cell count is equal to or higher than 350 and has never been less than 200; viral load greated than or equal to 1,000; you are willing to comply with the study requirements and clinic policies; you have a primary care physician who will take care of you for your HIV infection;you agree to follow strict contraception methods which include two reliable methods of birth control during the study (this applies to both men and women). You will not be allowed to participate if: you are currently on antiretroviral therapy or have received it within 12 weeks of screening for this study; you intend to start therapy with the 57 day study period; you have previously taken leflunomide; you have previoulsy received IL-2;you have received other immunomodulatory agents such as hydroxyurea, mycphenolate, cyclosporeing, rapamycin, anti-HIV vaccines, interleukins other than IL-2, interferons, within 60 days of the study, you have received corticosteoids by mouth or injection within 30 days of study and yes, there's more. I'll stop here and encourage you to contact Mary DeGrezia, R.N. at NIH at 301-496-7040 to discuss. They've had a difficult time recruiting participants as there is a minimum of 5 to a maximum of 7 visits involved. If you think you may be eligible, I hope you'll check into it further. Thank you.  :)Em

Offline Ihavehope

  • Member
  • Posts: 1,366
  • Yes, I'm a cry baby, AND WHAT?
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #1 on: December 14, 2006, 03:14:00 PM »
How is this clinicla trial going?
Infected: April 2005
12/6/06 - Diagnosed HIV positive
12/19/06 - CD4 = 240  22% VL = 26,300
1/4/07 - CD4 = 200 16% VL = ?
2/9/07 = Started Kaletra/Truvada
3/13/07 = CD4 = 386 22% VL ?

Offline AustinWesley

  • Member
  • Posts: 815
    • HIV Discussion Group on Myspace!
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #2 on: December 19, 2006, 10:23:30 PM »
There is a current double-blind NIH study for which they are now recruiting the 13th of a total of 18 subjects needed. The purpose of the study is to evalute the effect of leflunomide, an immunomodulatory drug (that can fine tune the immune system), on the life cycle of CD4+ T cells in persons infected with HIV. Leflunomide (also called Arava)is a drug which has been approved by the FDA for the treatment of rheumatoid arthritis. It works by blocking the cell division of activated T cells. In HIV infection, the HIV virus causes increased activation of T cells. Activated CD4+ Tcells become more easily infected by HIV and die. If an immunomodulatory  drugs such as leflunomide coud be used to block the cell diviion of activated T cells, it could decrease the number of cells that die becuse of continuous division and also decrease the cells in which HIV can reproduce leading to a lower level of HIV virus in the body. This is the basics of the study---of course, there is more text. Here's the criteria: be between ages of 18 and 65; have HIV infection;CD4+ cell count is equal to or higher than 350 and has never been less than 200; viral load greated than or equal to 1,000; you are willing to comply with the study requirements and clinic policies; you have a primary care physician who will take care of you for your HIV infection;you agree to follow strict contraception methods which include two reliable methods of birth control during the study (this applies to both men and women). You will not be allowed to participate if: you are currently on antiretroviral therapy or have received it within 12 weeks of screening for this study; you intend to start therapy with the 57 day study period; you have previously taken leflunomide; you have previoulsy received IL-2;you have received other immunomodulatory agents such as hydroxyurea, mycphenolate, cyclosporeing, rapamycin, anti-HIV vaccines, interleukins other than IL-2, interferons, within 60 days of the study, you have received corticosteoids by mouth or injection within 30 days of study and yes, there's more. I'll stop here and encourage you to contact Mary DeGrezia, R.N. at NIH at 301-496-7040 to discuss. They've had a difficult time recruiting participants as there is a minimum of 5 to a maximum of 7 visits involved. If you think you may be eligible, I hope you'll check into it further. Thank you.  :)Em

I'm amazed anyone would jump on this study after reading this description.   Damn, don't they get a fruit basket or a toaster or something?   It just doesn't sound too appealing here.   
Diag. 3/06  Infected aprx. 2 mo. Prior
Date        CD4   %      VL
4/6/06     627    32    36,500     NO MEDS YET!
6/7/06     409    27    36,100
8/23/06   408    25     22,300
1/2/07     354    23     28,700
2/9/07     139    30     23,000  Hep A Vaccine same day???
2/21/07   274    26     18,500 
3/3/07    RX of Truvada/Sustiva Started.
4/5/07    321     27      Undectable 1st mo.  
5/16/07  383     28    Undectable 2nd mo.
8/10/07  422     32   UD <48 on new scale!

Offline emeraldize

  • Member
  • Posts: 3,353
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #3 on: December 19, 2006, 11:25:53 PM »
Hi Austin
I just finished participating in this trial yesterday. I was on drug as opposed to placebo. All in all, I made seven trips to the NIH for the study. While rather involved, in terms of time, the 72-day study involved taking one pill per day for 30 days and then, because it was drug, taking cholesteramine to remove the drug from the liver. By Thursday I'll know if I'm cleared of it. If you, or anyone who's reading this, believe you may be eligible, I encourage you to inquire. It's what is called " a no benefit to you study."
Em

Offline AustinWesley

  • Member
  • Posts: 815
    • HIV Discussion Group on Myspace!
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #4 on: December 20, 2006, 04:13:26 AM »
Yeah, I can see that from the original description.   I don't know why anyone would be eager to jump in on something like this for nothing?

I mean if that's your thing I'm not gona attempt to stop ya.   Or I suppose if meds were failing me at some point I'd try this as a last resort.   I guess I'm trying to understand the situation here.   
Diag. 3/06  Infected aprx. 2 mo. Prior
Date        CD4   %      VL
4/6/06     627    32    36,500     NO MEDS YET!
6/7/06     409    27    36,100
8/23/06   408    25     22,300
1/2/07     354    23     28,700
2/9/07     139    30     23,000  Hep A Vaccine same day???
2/21/07   274    26     18,500 
3/3/07    RX of Truvada/Sustiva Started.
4/5/07    321     27      Undectable 1st mo.  
5/16/07  383     28    Undectable 2nd mo.
8/10/07  422     32   UD <48 on new scale!

Offline emeraldize

  • Member
  • Posts: 3,353
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #5 on: December 20, 2006, 10:00:06 AM »
Hi Austin,

Being involved in research is, I suppose, "my thing."  What may not be clear is the NIH views me as a long-term non-progressor or what some describe as a viremic controller. More openly stated, since diagnosis I've not been on meds, have a relatively high CD4 count and very low viral load. I decided a couple of years ago that as long as my numbers, energy and time allow, I'll enroll in studies. While there's no guarantee I'll enjoy this status forever, I figure it's best to make research hay while the sun shines.

I cannot envision doing otherwise given the state of the world and closer to home the degrees of illness with which some of our forum members struggle. If people are not involved in research, then the likelihood of developing new drugs, new uses for existing drugs, vaccines or cures is lessened.

I hope this makes it clearer and hopefully, enthuses others to consider enrolling in research studies for which they're eligible.

Em

Offline AustinWesley

  • Member
  • Posts: 815
    • HIV Discussion Group on Myspace!
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #6 on: December 20, 2006, 12:44:08 PM »
Hey Em,

Yes, that does make a lot more sense to me.   According to the study guidelines I qualify from what is written here and so would a lot of people, but you have a unique situation.   If I were in that situation I would have a much different view.

Thanks for taking the time to fill me in.   Best of luck to you!

Wesley
Diag. 3/06  Infected aprx. 2 mo. Prior
Date        CD4   %      VL
4/6/06     627    32    36,500     NO MEDS YET!
6/7/06     409    27    36,100
8/23/06   408    25     22,300
1/2/07     354    23     28,700
2/9/07     139    30     23,000  Hep A Vaccine same day???
2/21/07   274    26     18,500 
3/3/07    RX of Truvada/Sustiva Started.
4/5/07    321     27      Undectable 1st mo.  
5/16/07  383     28    Undectable 2nd mo.
8/10/07  422     32   UD <48 on new scale!

Offline emeraldize

  • Member
  • Posts: 3,353
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #7 on: December 20, 2006, 03:57:20 PM »
Hey Wesley,

You're most welcome and if you're inclined, since you believe you qualify, I hope you'll check into it further. They do fly you in, put you up in a hotel, provide a daily meal stipend which while quite modest is ultimately augmented by the payment for participation in the study which comes at the end of one's participation.

At last count, they were at 13 and needed 5 more. That may have changed since I was there.

Em

Offline bobino

  • Member
  • Posts: 264
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #8 on: December 22, 2006, 01:13:37 AM »
Em,

Just wanted to say kudos to you for participating and for your attitude.  I agree that all of us should be involved in research to the extent our circumstances permit.  I try to do what I can in that regard.  Keep up the good work.

John
Suivons les rivières
Gardons les torrents
Restons en colère
Soyons vigilants

Offline Longislander

  • Member
  • Posts: 2,486
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #9 on: December 23, 2006, 02:56:57 PM »
Em, thanks for doing it! Fly you in to where? Weekends?
infected 10/05 diagnosed 12-05
2/06   379/57000                    6/07 372/30500 25%   4/09 640/U/32% 
5/06   ?? /37000                     8/07 491/55000/24%    9/09 913/U/39%
8/06   349/9500 25%              11/07 515/68000/24     2/10 845/U/38%
9/06   507/16,000 30% !          2/08  516/116k/22%    7/10 906/80/39%
12/06 398/29000 26%             Start Atripla 3/08
3/07   402/80,000 29%            4/08  485/undet!/27
4/07   507/35,000 25%            7/08 625/UD/34%
                                                 11/08 684/U/36%

Offline emeraldize

  • Member
  • Posts: 3,353
Re: JUST FIVE MORE PARTICIPANTS NEEDED!!!
« Reply #10 on: December 26, 2006, 03:37:26 PM »
Bobino and LI

Thanks for your nice words. The NIH flies you into Dulles/DC (typically) and then you take a shuttle to Bethesda. I usually go Sunday nights so that I can return to work the afternoon of Monday.

Em

 


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