AMPLIGEN 516 STUDY IN CHARLOTTE,NC

Discussion in 'Fibromyalgia Main Forum' started by TiredbutWired, Oct 4, 2002.

  1. TiredbutWired

    TiredbutWired New Member

    I just got back from Dr.Lapp and he needs more subjects for his last study.It is a randomized,double blinded,placebo controlled crossover study,subjects will be intially assigned randomly to either treatment or placebo.After a baseline period of at least 12 weeks,the treatment phase will begin.Those randomized to treatment will receive Ampligen for 10 months,while placebo subjects will receive saline infusions.Neither the subjects nor the investigators will know who is receiving Ampligen or placebo.At the end of 10 months,ALL subjects will receive Ampligen for 6 months.Thus each subject will ultimately receive either 6 or 16 months of ampligen therapy.All subjects will be followed up at 2 years.Placebo or ampligen doses of 200-400mg will be infused intravenously twice weekly.Each infusion takes approximently one hour plus set-up time,and will be performed at the Hunter-Hopkins Center.During the treatment period it is highly recommended to live in the metropolitan Charlotte or within a one hour drive.There is no charge to the patient to participate in this study.I talked to someone that is the study now and he said you really can not travel back and forth,he said he tryed.The subject must meet 1988 CDC criteria for Chronic Fatigue Syndrome,must be 18 to 60 years old and severely ill,with a Karnofsky score of 40-60{essentially house bound and requiring considerable assistance with daily needs}.The subject must be able to participate on an exercise tolerance test,and there can be no evidence of systemic lupus or rheumatoid arthritis.Significant or uncontrolled disorders like asthma,heart disease,or diabetes may disqualify a participant.Female subjects with child-bearing potential must agree to use effective means of contraception such as birth control pills,an intrauterine device,or diaphragm.There are also certain drugs you can not be on.You can go to his site for more info dr.lapp.net and there is also a place at the end for comments that he always reads.I want to be in it bad and he has accepted me I am just not sure I can leave my animals for that long.You can also contact Hemispherx Biopharma,Inc.[makers of ampligen}and in writing you can request info and they will send you a packet in the mail of all the sites involved in the studies.There are 15 sites on my list and most of them have completed their study.I will do my best to answer any questions promptly but I am having syncopal episodes,just got out of hospital and sometimes I can not write or see computer screen.It took me hours to copy this but I wanted to get the info out there.There are several apartments around there that are about 500 a month and he said that many of the people stay at the same complex and support each other.I hope someone can benefit from this.Love,Tracey
  2. TiredbutWired

    TiredbutWired New Member

    I just got back from Dr.Lapp and he needs more subjects for his last study.It is a randomized,double blinded,placebo controlled crossover study,subjects will be intially assigned randomly to either treatment or placebo.After a baseline period of at least 12 weeks,the treatment phase will begin.Those randomized to treatment will receive Ampligen for 10 months,while placebo subjects will receive saline infusions.Neither the subjects nor the investigators will know who is receiving Ampligen or placebo.At the end of 10 months,ALL subjects will receive Ampligen for 6 months.Thus each subject will ultimately receive either 6 or 16 months of ampligen therapy.All subjects will be followed up at 2 years.Placebo or ampligen doses of 200-400mg will be infused intravenously twice weekly.Each infusion takes approximently one hour plus set-up time,and will be performed at the Hunter-Hopkins Center.During the treatment period it is highly recommended to live in the metropolitan Charlotte or within a one hour drive.There is no charge to the patient to participate in this study.I talked to someone that is the study now and he said you really can not travel back and forth,he said he tryed.The subject must meet 1988 CDC criteria for Chronic Fatigue Syndrome,must be 18 to 60 years old and severely ill,with a Karnofsky score of 40-60{essentially house bound and requiring considerable assistance with daily needs}.The subject must be able to participate on an exercise tolerance test,and there can be no evidence of systemic lupus or rheumatoid arthritis.Significant or uncontrolled disorders like asthma,heart disease,or diabetes may disqualify a participant.Female subjects with child-bearing potential must agree to use effective means of contraception such as birth control pills,an intrauterine device,or diaphragm.There are also certain drugs you can not be on.You can go to his site for more info dr.lapp.net and there is also a place at the end for comments that he always reads.I want to be in it bad and he has accepted me I am just not sure I can leave my animals for that long.You can also contact Hemispherx Biopharma,Inc.[makers of ampligen}and in writing you can request info and they will send you a packet in the mail of all the sites involved in the studies.There are 15 sites on my list and most of them have completed their study.I will do my best to answer any questions promptly but I am having syncopal episodes,just got out of hospital and sometimes I can not write or see computer screen.It took me hours to copy this but I wanted to get the info out there.There are several apartments around there that are about 500 a month and he said that many of the people stay at the same complex and support each other.I hope someone can benefit from this.Love,Tracey
  3. LouiseO

    LouiseO New Member

    Do you just call there and ask about the study? I would love to do it.

    Luv Ya, Louise

    Thank you so much (((((( Tracy )))))))
  4. TiredbutWired

    TiredbutWired New Member

    He said that you could write on his web at the end,I think it says guest comments.But you can certainly call they are all very freindly and helpful.I am not sure if you have to pay for the visit for him to evaluate you to see if you qualify.They have had great success with ampligen and he said if it does get approved it could be a couple of years before its available.I want to do it so bad just because I want to feel useful and feel like I am making a difference even if it does not help me.If you want I can mail you the info from the company.Just let me know and I will give you my email address.Best Wishes,Tracey
  5. TiredbutWired

    TiredbutWired New Member

    You sound like you would be perfect for the study.I would be happy to mail you info on ampligen,I also have a outline from someone that just finished his 10 weeks with Dr.Lapp and is just starting his Ampligen.I just would prefer to mail it because I can not type all that.I would love to know more about your episodes,I have a black eye right now and my face is all swollen.Love,tracey
  6. dlizard

    dlizard New Member

    tonight. I can;t believe he reads the emails himself.... wow.... impressive. I have no clue if I'll qualify but I'm going to see!!!!!! you made me feel better tonight Tracey by offering some hope!! I have an unsupportive rheumatogist and live in Columbia SC just about an hour from charlotte and I have a great support system,,,, so maybe..... I'll cross my fingers LOL>>>>>> THANK YOU!!!!!!
  7. TiredbutWired

    TiredbutWired New Member

    Any time I see someone that lives so close I get a little jealous but It also makes me very happy and I hope that you will be able to participate.He told me that he reads all the email but sometimes he gets a little behind.You can fax him or mail him your information.I think that I would try to write him a letter and send copies of all my medical records,that should give him a pretty good start if you would qualify.Let me know if I can help in any way!I will say a pray that everything works out.Love,Tracey
  8. dlizard

    dlizard New Member

    I wouldn't need him LOL>>>>>> honey I have so many medical records it would take a truck to take them to charlotte LOL>>>>> *truth* and I have no physician support or the money to pay him 330/hr outta my pocket... I'm interested in the study but I understood it's free.... I can't posssibly bear the costs for a drug company to gather my records and send them. That would most likely cost me about 500 bucks seriously..... here you pay for each page requested by yourself and you pay nothing when a doc requests them..... so if he needs all of that... o well.Thanks anyway
  9. TiredbutWired

    TiredbutWired New Member

    Sorry,my brain does not work that well these days and I did not think about all that.He just told me that people could write on the end of his email and he is very excited to get started.I am trying to find out if there would be any fees for evaluation.I did not think to ask him,I can not even remember what day it is.If your interested I wish you best.I hope I am lucky enough to know someone to make the sacrifice,I am still trying to find a way for me to go with my ocelot.Love,Tracey
  10. TiredbutWired

    TiredbutWired New Member

  11. dlizard

    dlizard New Member

    I wrote them on the web and got a phone call in a few days but they turned me down :( but thank you for your info.... I wanna follow this closely cause I know* it would help me! Good luck if your in!!!!
  12. TiredbutWired

    TiredbutWired New Member

    Did they say why?I wish I could give you my spot if I do not go.Thank you for writing me the latest.Tracey
  13. lilladybug

    lilladybug New Member

    Baloney to your doctor if it is an HMO!....Immunosciences lab does the test,also ask for the 2' 5' A synthetase 2nd part to the test......These tests are done all the time but maybe resources and time were on your docs mind. You must have your blood shipped to California immediately on ice or whatever they do and fed ex........

    It is very interesting to see ...your Rnasel level declines slowly with the illness so go get it as soon as possible!!!
    They were once considering this as a "marker" for CFIDS and FMS.

    At any rate a higher Rnase L means your body is upregulated and trying to fight something....virus, mycoplasma, bacterial infection....etc.

    Good luck!!!

    Lilladybug
  14. TiredbutWired

    TiredbutWired New Member

    Still needs about 10 to 15 people!Please let me know if anyone gets in.Thank You,Tracey
    [This Message was Edited on 10/19/2002]
  15. TiredbutWired

    TiredbutWired New Member

    It is a full time job trying to keep this where the new people can see.I just talked to a freind that is in the current ampligen study.Hemispherx needs to complete their phase 3 AMPLIGEN trail and Dr.Lapp is willing to take on 25-30 people to do it.He has never taken this many before.This is it,if it does EVER get improved it could be 2 years at the min.Ampligen has been sucessful with some cases of high titers of HHV-6.It has also helped in some hiv patients and cancer patients,it is not a cure but has been a great anti-viral drug.So be patient with me,I am sorry if you are sick of this getting bumped.But I had been looking for info on Ampligen for a long time and it seems like there are new people her all the time.tracey

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