Dr.Montoyas clinical trial in Feb.07/ Valganiclovir inCFS/HHV-6

Discussion in 'Fibromyalgia Main Forum' started by karinaxx, Jan 7, 2007.

  1. karinaxx

    karinaxx New Member

    who were experiencing central nervous system dysfunction including long-standing fatigue
    A Randomized, Placebo-Controlled and
    Double Blind Study at Stanford University

    Drs. Jose Montoya and Andreas Kogelnik of Stanford Hospital Infectious Disease Clinic are planning a double blinded placebo controlled clinical trial to determine whether patients with Viral Induced CNS Dysfunction, a subset of patients with Chronic Fatigue Syndrome, would benefit from valganciclovir treatment.

    The trial will enroll 30 patients and is expected to start in February 2007. The HHV-6 Foundation has supported this group to initiate and design the trial and Roche Pharmaceuticals, the manufacturer of valganciclovir, has agreed to fund the study in full. This trial was precipitated through a preliminary study conducted by Drs. Montoya and Kogelnik announced at the 2006 HHV-6 & HHV-7 Conference in Barcelona which reported the successful response to antiviral treatment experienced by nine out of 12 (75%) of patients chronically infected with human herpes virus 6 (HHV-6) and Epstein-Barr virus (EBV) and who were suffering from debilitating fatigue for more than one year (median 3 years, range 1 to 8 years). In these patients antibody titers dropped four fold suggesting (a) these patients had active infections (b) elevated antibody levels can be a useful indicator of active infection in some patients and (c) a subset of patients with CFS and elevated antibody levels to HHV-6 and EBV may have an illness that is caused by reactivation of these viruses, and that is responsive to valganciclovir therapy.

    The successful results as well as the limitations of the preliminary study have warranted a larger, randomized controlled trial with long-term follow-up to confirm the possible value of antiviral therapy and exclude a placebo effect. Additionally, the study aims to establish a quantifiable biological marker in these patients that will facilitate the identification of those likely to respond to valganciclovir and will make it possible to assess response to treatment. The planned study will provide further definition of this subset of patients, with better and more standardized viral assays as well as immunologic, radiological, and genetic endpoints to determine whether there are objective and measurable changes in these parameters and whether they correlate with clinical improvement. Despite the fact that the improvements in physical activity and cognitive functions were dramatic and impressive in the
    preliminary group, they were self-reported and not objective measurements. The planned study will utilize a more comprehensive evaluation of the functional status of subjects, using established and validated instruments. The resulting data from the trial will help to elucidate the possible role of EBV, HHV-6 (or a yet to be known virus) and/or an altered immune system as possible triggers for CFS.

    Dr. Montoya is in the process of collecting data from prospective patients for his clinical trial. If you are interested in participating in the trial, please email the following information to: StanfordTrial@hhv-6foundation.org.

    All test results should be from within the last 6 months. While Stanford does not endorse a particular metric or lab, they would prefer that the results be measured using the IFA format and FOCUS diagnostics is one such lab which uses this metric. If the labs are drawn through Quest, please make sure that “Please send to Focus” is written across the top of the lab requisition.

    1. Your full name
    2. The name of your primary care physician, physician address, phone and email.
    3. HHV-6 IgG and IgM levels including the name of the lab, lab address, date of the tests and the reference range.
    4. EBV VCA IgG levels and IgM including the name of the lab, lab address, date of the tests and the reference range. Also include EBNA and EA IgG levels if available.
    5. Thyroid results and dates, including FT4 and TSH
    6. Approximate date your symptoms began
    Your date of birth
    8. Any diagnosis other than chronic fatigue
    9. A list of current medications

    HHV-6 and EBV PCR DNA tests results should not be
    sent unless they are positive.

    Including your latest Complete Blood Cell Count (CBC), uric acid levels, and Complete Metabolic Panel, would be helpful. Also please include reports on any immune system workup (Natural Killer Cell count or function, IgG and subclass levels) as well as any T-cell analysis if done.

    [This Message was Edited on 01/07/2007]
    [This Message was Edited on 01/08/2007]
  2. karinaxx

    karinaxx New Member

    nobody interested in this and signing up for it?

  3. foxglove9922

    foxglove9922 New Member

    I find this fascinating but not out of range in terms of travel for me.

    Is Valganciclovir the same as Valcyte? My physician is currently running a study with this med but has seen drops in bone marrow counts utilizing only a few patients.

    Bumping for anyone who may be interested.

    [This Message was Edited on 01/08/2007]
  4. winsomme

    winsomme New Member


    is that Dr Enlander that is also trying valcyte?

    if so, i see the bone marrow counts are dropping, but are the patients feeling any different?

  5. cherylsue

    cherylsue Member

  6. BobinGermany

    BobinGermany New Member

    I live in Germany..... I wish I was closer. I would join in a heartbeat! Good luck to all who do this and I pray for all of us that this works!
    God Bless,
  7. karinaxx

    karinaxx New Member

    inform yourself well before you start. there is information about the risks on their website.Valganiclovir the most heaviest AV existing and is controversal, because it can severe side effects.
    But if were alone, no kids and have nothing to loose, than i would go for it.

    to all others, as far as i know Valcyte is not the same and a far less heavy hitter.

    take care
  8. shar6710

    shar6710 New Member

    I saw this in a newsletter awhile back. I wish I could travel that far I'd love to participate.

  9. foxglove9922

    foxglove9922 New Member

    Hi Bill,

    It's Dr. Susan Levine who is trying Valcyte. She's been consulting with Montoya and has pulled back for time being (ie. do no harm).

    She will be speaking next week at the conference in FL,,,I have a phone consult soon with her,,,,,,hoping for some good news!!

    best wishes,

  10. karinaxx

    karinaxx New Member

    sorry to hear your bubble burst.........it is very scary. the best would be to actually get in contact with the people who went through the first trial and especially those who app. did not improve.
    dont know if that would be possible.

    other than that we just have to wait for the development of a less harmfull AV ,which will take years.

    it is weighing the risk against, what have you got to loose.
    for those who are sick a very long time and can barly go on living like this......?

    take care

  11. deliarose

    deliarose New Member

    One's a tradename.. t'other is the one used in pharmaceutical circles.

    the antiviral with the similar name but less potency is Valtrex.

    Foxglove, can u elaborate on Levine's experiments with Valcyte?

  12. Slayadragon

    Slayadragon New Member

    Those interested in this may want to read my thread:

    "A Strategic Plan for Getting Truly Well (Believe it or Not)"

    I currently am on a less potent anti-viral, Famvir. The plan is to get as much die-off as possible with that, then to move to Valcyte for a shorter period of time when my body is in better shape.

    So far, things are going very well. You can read my Famvir Status Report threads if you're interested.
    [This Message was Edited on 01/09/2007]
  13. swedeboy

    swedeboy Member

    I have an official appointment with Dr.Montoya in February. I am so excited! I really want to be accepted into the study and I really want this treatment to help! Wish me luck, I'll keep ya'll posted on the details.
  14. lisagra

    lisagra New Member

    on 1/24/07. i'll post the results of the meeting. wish me luck!!!

    regards lisa
  15. swedeboy

    swedeboy Member

    Hi Lisa, if you dont mind me asking, do you live in the San Jose area. I am curious because I am looking for a good General Practioner Doctor and I am wondering if you have one or know of one that you can refer me to. I live in Saratoga, just 20 minutes south of Stanford.

    Thanks, Swedeboy[This Message was Edited on 01/09/2007]
  16. karinaxx

    karinaxx New Member

    i read your profile and it sounds like my life story, so much the same; except i cant realy remember when it started exactly. Same as you: the scary thing is that i am getting worse from year to year, no matter what i do.(considerable worsenend with two ABX treatments the past three years)
    same as you: i was a exercise junkie (one of the best female racket players around here and at times three hours yoga a day)traveled since i was 17 y. it was, i think, the pregnancy which triggered it to real noticible symptoms, but the exercise problem (pain in the legs and flu symptoms, bronchial problems all my life) and allergies, intolerance to alk. were noticable before.

    now i am 25 kilo overweight, cant do yoga or do any sports, even cleaning floors causes me pain. feel like a living example of a 200 year old ......
    and my son , 10 y. old got it too....

    with all my heart: i wish you good luck and keep us posted, no matter how it goes!

    same to all the others who will join the trial.
    [This Message was Edited on 01/10/2007]
    [This Message was Edited on 01/10/2007]
  17. shar6710

    shar6710 New Member

    That is so exciting please keep us posted. I hope you both get the actual drug and not the placebo.

  18. Slayadragon

    Slayadragon New Member

    I took a look at your profile and can see why Montoya would be willing to see you. Your case is very clearly defined (e.g. extremely healthy --> extremely debilitated) and uncomplicated (e.g. without atypical symptoms or history). Antivirals alone might work for you, therefore.

    I'm going to be moving to Valcyte soon (within the next month or two). I'm currently taking Famvir, which is a less potent version of the same drug.

    Have you focused at all on strengthening your adrenals? After having been on Famvir for two months, I've realized that having the adrenals in good shape is by far the most important thing that constitutes whether people succeed or fail on these drugs.

    Oh, I live in Chicago and see a doctor in Indianapolis.
    [This Message was Edited on 01/10/2007]
  19. sturg1

    sturg1 New Member

    Hi Everyone,
    I sent the info that was requested to the HHV6 foundation, haven't heard back yet. How long did it take for you to hear from them Swedeboy and Lisa?

    I have mixed emotions after reading about the AVs here on the board. My dr has had me on a couple of therapies to strengthen my immune system (for a year) and now on Lauracidin (sp) a natural AV. I know he worries about the toxicity of the current AVs out there. I meet with him next week and will discuss the clinical trial.

    Thank you to all who post their experiences with the AVs. I learn so much.

    Having a pretty painful and "sick" day today. This all scares me.

    Take Care,
  20. swedeboy

    swedeboy Member

    Wow thanks for all the support guys! Thanks Karina, and do you really live in India, that's pretty cool, I love Indian culture and the food too!. AND also Thanks to Shar6710, Lisa, Cat003, and Sturg1, For the comments!

    Yes I often wonder about strengthing my adrenals. I took Teitelbaum's adrenal formula for several months and I didn't notice any benefits. I have had my cortisol checked twice. Both times it was in the upper range. Last time I had it checked was about 1 1/2 years ago.

    It was 17 and the range was like 5-20. My doctor told me it was rather high and that I need to "de-stress." However, my condition has worsened considerably since then, and I do think that my adrenals are week. Any suggestions for treatments would be great!

    About Montoya:
    I called his office and spoke directly with his assistant Deleores. I hope he doesn't mind me giving his office number out, but here goes, it is 650-725-8439. I hope everyone that can truly be helped by this study get accepted.

    I think the limit of 30 controls should be increased if need be. I had to have a referral from my GP Doctor and I had to have specific lab results sent to his office. And after they recieved all of the requirements I was given an appointment.

    Peace and Love, Swedeboy
    [This Message was Edited on 01/10/2007]

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