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xmrv+ starting AV's tenofovir and raltegravir

Discussion in 'XMRV Testing, Treatment and Transmission' started by pinkytuscadaro, Jan 27, 2011.

  1. anncavan

    anncavan

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    Hi all,
    Based on some of the questions that have been raised, I thought I'd share some notes I took recently after seeing an HIV specialist. I went, just to learn more about ARVs and to have someone "on my team" that understands these drugs intimately should I decide to go on them. I would most likely not ask him to be the one to prescribe me, as he is not well informed on XMRV. Here's what I wrote after the appt:

    Note he is not an Infectious Diseases specialist, but a Family Practice Doctor who has been specializing in HIV for many years here in SF. He admitted he really only dives into research when he's at conferences, and instead concentrates on the daily treatment of his patients. He is not involved in XMRV.

    Of the 3 (AZT, Raltegravir, Tenofovir) he would recommend Raltegravir and Tenofovir together, given the success rate with any two. AZT has way more side effects. He also noted that Tenofovir and AZT are of the same class of drugs (reverse transcriptase inhibitors). I forget the class of drug that Raltegravir is, but he specified that it stops HIV from incorporating itself into our DNA. XMRV does incorporate into DNA, so I can see the benefit. He stressed this idea of attacking in two different places, therefore 2 different stages of the lifecycle, through two different class of drugs(Tenofovir + Raltegravir), and how this would be more effective. He starts HIV patients on Raltegravir 400mg, 2 times a day and Tenofovir at 300mg, once a day. He noted there is no weening up in HIV. You have to hit and hit hard otherwise it gives it time for virual mutations to create. I told him how Brewer didnt start patients on both drugs at the same time. He said that was not the case in HIV. So I'm not sure about weening up/down. He also said he has had patients on Valcyte for CMV with these drugs, you just have to keep an eye on the liver. However he noted less and less HIV patients get CMV (the one you get in the eye) as they're catching and treating HIV so much faster these days. I asked this as I'm on Valcyte now, and wanted to knwo if I had to come off of it. I think it would be A LOT for my liver to take, and probably wouldn't try both.

    Next I asked about Peptide T. He knew there had been discussion years back, but nothing ever went anywhere. He did mention a peptide-like licensed(i.e. FDA approved) injection called Fuzeon (enfuvirtide). It bindes to the T4 molecule so once the HIV virus tries to attach to the cell it can't. The Fuzeon is already in the place where it would bind, so in effect blocks the binding. I don't think T4 is involved in XMRV (correct me if I'm wrong here), but the theory is interesting.

    I mentioned GcMAF and he was not up to speed on it. But he understood the theory behind the likes of GMAP, Ampligen, etc. We talked how Judy Mikovits mentioned her concern/interest in the possibility of these drugs (GcMAP, Peptide T, Stem Cells) possibly activating latent "reservoir" XMRV. How she thinks it could be good if you followed them up with ARVs. One-Two punch. He jumped on this and said that's what they're looking for in HIV, the holy grail. The best way to treat is to activate HIV as much as possible so they can reach it and kill it. They have tried to activate via interlukons and interferons without success. He also noted however, in these trials, they'd NEVER do these tests to an AIDS patient without allowing them to be on AVRs (in response to how Ampligen candidates are not allowed on ARVs or RVs).

    I told him how Dr. Mikovits mentioned what seemed to be an improvement by month 6, and then a plateau or crash. He said that didn't happen with HIV patients. He also noted that once on AVRs you stay on them indefinately. It wasn't a 6-18 month type of treatment. I never really see that discussed much out there. But sounds like ARVs could be a lifelong commitment.

    That's all I had. Hope it's helpful to someone! :)
    Lannie
  2. undcvr

    undcvr Senior Member

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    Hey Lannie thanks so much for all that info, really good to know. Raltegravir is an integrase inhibitor. I am on Valcyte too and will ask my doc to put me on Issentress too when I next see him. Did you see the post on this thread earlier that Pinky put up here ? Issentress works on dna viruses in the Herpes class too and not just exclusively on retroviruses. I am thinking that if long term and Issentress is effective, I would rather go on that than Valcyte.
  3. citybug

    citybug Senior Member

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    great info. i hope first days are going well.

    Lannie, did the Hiv doc say anything about toxicity? That's what the cfs doctors who don't want to do ARVs bring up. I wonder if we would be greatly different.
  4. undcvr

    undcvr Senior Member

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    I have a fren who is hiv+ and recently just started the ARVs, it will be almost a month soon. So far no side effects and says that he is feeling better. He is on the same drug combo that Pinky is on plus 1 more. Issentress's safety profile is so much better than Valcyte's ! He only needs to have his blood tested once in 6 weeks while on his hiv ARVs, I need to have mine checked once every 2 !

    I actually know 3 people on the hiv ARVs, none have reported any side effects. On top of that the drug companies are so on top of it that every few years they come up with even better ARVs that have a better and better safety profile ! All they have for the herpersvirus are some really old drugs that are carcinogenic, mutagenic and tetragenic ! Wtf ?? I hope Issentress changes that.
  5. pinkytuscadaro

    pinkytuscadaro

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    My first report.
    First of all Sorry, Daff is right I am taking one Isentress 2x a day @400mg. I am very prone to errors and edited the post.
    This is my third day on both drugs and I have noticed that I am dizzy and I feel a little pressure in my head.
    I also started LDN the same day I started the AV's.
    I have felt very excited about starting this treatment.
    I googled viread and (tenofovir) and there is a patient assistance program
    www.viread.com/en/400.cfm
    The company will reimburse you for the amount you pay for viread over the first 50.00, from what I understand. They say to ask your pharmacy about the program.
    Thanks again for all the well wishes. Wishing you all wellness too :)
    Pinky
  6. pinkytuscadaro

    pinkytuscadaro

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    Lannie,
    Where did you hear about the 6 month improvement and then a crash? Please post back with this info.

    With xmrv some people have experienced a bad reaction when starting both insentress and ralt at the same time,
    With HIV this is notsuppose to be a problem.
    79 you are right: I may get a harsh reaction from starting both meds at the same time. I am hoping it won't be a problem, I did not want to give the virus a chance to get stronger.
    Also Lannie, hopefully we can get some level of a cure from the drugs that are now available and in the future they will make something better so we can eventually get off of these.
    Pinky
  7. undcvr

    undcvr Senior Member

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    You have to start both meds at the same time and at the exact dose that the doc is prescribing otherwise it gives the virus a chance to mutate to the drugs and become resistant to it.
  8. Cort

    Cort Phoenix Rising Founder

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    God bless Pinky! You deserve something to work... Sending good thoughts in your direction!
  9. slayadragon

    slayadragon Senior Member

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    twitpic.com/photos/SlayaDragon
    This is exactly the rationale that Jose Montoya gave in 2007 for giving huge "loading doses" of Valcyte to patients. A lot of those patients got a lot worse as a result (not recovering for months or years, if ever), and few patients made improvements. Three years later, so I hear, he's now prescribing more moderate doses.

    Remember Judy Mikovits stating that XMRV (re-)activates as a result of inflammation, cortisol, androgens and estrogens?

    If hitting the virus hard on the front end creates an inflammatory flare, isn't that counter to our purposes?

    I presume that our immune systems will need to be working at little bit to help the drugs. Doing anything to weaken our systems couldn't be a good thing.

    If the virus flares as a result of the inflammation, there's going to be more of it around to mutate.

    I find it very odd that doctors are arbitrarily taking the same strategy that they did with the herpes viruses, rather than having learned from how things went with them.

    ME/CFS patients are different from any others on the planet. What works for other patient populations usually does not work for us.

    That doesn't mean that the strategy being proposed -- full dose, multiple drugs, all at once -- isn't correct. But it does disturb me that people don't seem to be thinking it out fully before proceeding.

    Best, Lisa
  10. citybug

    citybug Senior Member

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    Can anyone report about taking Actos with the ARVs or immune modulators or antiinflammatories? Thanks Kathy
  11. Tia

    Tia Senior Member

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    Very wellwritten and informative piece you've got there!

    I'm neither a researcher (other than an amateur one reading the net) or a doc, but think it sounds highly logical with getting all the reserve of the virus out so it can be exterminated. And as Pink said, I think we'll start on the AV's that exist now and then on something Judy & Company has translated (that they're doing right now as far as I know) and we'll have to be on that until they simply can find a cure.

    What I'm missing is just someone coming on in the forum telling about before and after treatment, because I have heard that there are bedridden people that have gotten ALL better after treatment so I'd die to hear from them. Of course they probably won't be sitting in front of the computer, they're probably out living life and enjoying all they can do. :D But still, It'd be nice with a sunshinestory. :)

    Also think that there's something with when we get more pain, like that burning in the muscles. I think that's because the virus spreads in the body, but just a guess, it feels like it. remember when I first got that and had no idea I even had CFS, but I was sure there was something in my body that was spreading, and a few years later I found out I had CFS, and then about xMRV so could there be something in that or is it just my imagination?
  12. pinkytuscadaro

    pinkytuscadaro

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    Here is my smptom list that I will add to when other sypmtoms come to me Pinky

    symptoms 1-28-2011

    1. severe fatigue
    Low blood pressure
    Blood pressure drops when I stand
    Low body temp
    diagnosed with a heart murmur when I was 23 then again at age 45

    2. can not stand for long: after being up right for very long my body begins to ache I become weak
    and light headed eventually I can not hold conversation or
    find words while standing. Must lie down with head down. I can go out for about 2 to 4 hours once
    a month or so but when I do it take days to recooperate. Basically I live from my bed.
    3. I can not tolerate stress: small events take my strength for days. I become shorter of breath
    during stressful events.
    4. Loud noise bothers me. I can listen to an old good song loud every once in a while but then need to turn the
    music down as it begins to take my energy.`
    5. I am sensitive to cigarette smoke diesel rubber pesticides perfumes....etc
    6. I get dizzy easily
    7. my feet burn every night. I put frozen ice blocks (the blue kind that keep foods cold when packing)
    1"high 4"'wide 8" long into a pair of knee high socks and slide my feet into
    them everynight. I usually have to refresh the ice blocks 2 to 3 times a night.
    My feet have no odor or fungus this is and internal nerve feeling. My feet shed a lot and develop
    callouses easily.
    8. I have extreme dificulty falling to sleep. It has been severe at times especially for the first 10 years
    of this illnes I slept 15 to 18 hours at a time when I finally fell asleep, could hardly stand back then.
    I gave into using prescription sleep aids 18 years later in 2005 they have helped but I become
    immuned pretty quickly. I sleep an average of 10 hours+ if I sleep less I can not function at all: I
    can not make it to an appointment can not even do things from my bed.
    9. Shortness of breath that comes and goes from moderate to severe.
    10. Can not think deeply, can not remember things, do not balance check book, read books, study, learn.
    I become frustrated easily do not have enough energy to think deeply.
    11. Sensetivity to light eyes, severe.
    12. Allergies to pets wheat seasonal allergies.
    13. My stomach seems to have no activity I have taken up to 12 hydrochloric acid capsules with meals and
    not even felt my stomach burrn.
    I feel that I do not assimilate nutrients from my food or vitamins.
    14. My hair falls out, is dry and lost it's curl
    15. dry eyes
    16. subtle brown patches on top of feet
    17. agressive breast cancer 2001 cured :)
    18 constant dripping nose
    19. no wax in ears
    20 extreme sensitivity to cold and hot weather.
    21 very dry skin
    22. night sweats severe
    sever hot flashes night and day
    23. nerve like feeling that comes and goes: it feels like all of the nerves in my body are inflamed, it
    is awful.
    24. headaches and migraines
    25. low thyroid
    26. extreme hormonal disruption.
    27. red looking hands and feet
    28. urinate a lot at night before falling asleep and wake to urinate
    29. neck strain that I have described as my head feeling like a bowling ball that is being held up by a toothpick.
    This has been helped a lot by low dose cortisone 10mg.
    Boy, don't I sound like a winner :)
    Pinky
  13. pinkytuscadaro

    pinkytuscadaro

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    Lannie,
    I forgot to thank you for your post. It was so nice to hear what a HIV doc has to say.
    You did an excellent job.

    Reporting in for Jan 31st 2011:
    Feeling a bit sick to tummy a little fluish today.
    Nothing big.
    Wishing everyone a happy day.
    Pinky
  14. jimbob

    jimbob ME/CFS84-XMRV+

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    I'm sorry, was that your symptons or your Match.com submission? LOL Hang in there tough girl, we're all pulling for you.
  15. illsince1977

    illsince1977 A shadow of my former self

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    Pinky-Thanks for correcting the dose above. You got it right now. I read that HIV patients on ARVs and LDN did not develop lypodystrophy. Is that why you started LDN too? Because I recall your concern about it you used to mention.
    Undrcvr-HIV patients don't get the same inflammatory reactions to the drugs we do, so they start all simultaneously.
    Some people are finding Actos helps with inflammatory response ARVs induce (theoretically from doing their job of blocking replication of the retrovirus, others aren't helped by Actos.
    I think ginger is a good antiinflamatory.
    Randinni likes this.
  16. pinkytuscadaro

    pinkytuscadaro

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    Hey, Jimbob are you looking for a date :)
    1977 I guess the board will know I'm getting better when I stop making mistakes :)
    Yes I did read the article about the ldn and lypodystrophy and tried to post it but it didn't work so I am posting it this morning.
    Thanks for reminding me 1977 hope you are doing well.

    Report: I slept like a rock last night. I mean like a rock. I don't know if it was from the ldn but I think so. That was really nice. I am of this morning still just a little dizzy feeling and my eyes feel irritated (they have felt like that since starting the new meds)
    other then that I will post back hopefully at the end of the day.
    Have a happy day.
    Pinky



    www.lowdosenaltrexone.org www.ldninfo.org

    --------------------------------------------------------------------------------

    LDN and HIV/AIDS
    In Brief Recent Developments Noteworthy Cases What Patients Say Background LDN Homepage



    --------------------------------------------------------------------------------

    See also these in-depth historical reports on LDN for HIV/AIDS:
    "Low Dose Naltrexone in the Treatment of Acquired Immune Deficiency Syndrome," a paper presented in 1988 to the International AIDS Conference in Stockholm, Sweden, describing in detail the 1986 LDN HIV/AIDS clinical study.
    "Low Dose Naltrexone in the Treatment of HIV Infection," an informal description of the results in Dr. Bernard Bihari's private practice through September, 1996.

    --------------------------------------------------------------------------------

    In Brief
    Since the mid-1980's, low dose naltrexone (LDN) has consistently demonstrated a markedly beneficial effect in the treatment of HIV/AIDS. There are a score of such patients who, even today, continue to successfully use only LDN. When combined with HAART, LDN has shown itself to be an absolute preventive for lipodystrophy, as well as a synergistic therapy that diminishes viral breakthroughs and bolsters the restoration of CD4 cell levels.


    --------------------------------------------------------------------------------

    Recent Developments
    > Treating HIV Using LDN Alone
    Dr. Bihari reports that, as of November 2001, a group of 18 such patients had an average of 9.5 years of known HIV-positive status. They had been taking LDN continuously for an average of almost 7 years, and none had participated in regular maintenance therapy with HAART. Had these patients been untreated, their CD4 counts by now should have been at quite low levels and their clinical status should have been perilous.

    Instead, the most recent laboratory data for these patients shows that the vital indicators of immune status have, on average, declined only minimally during the many years. The average CD4 count within the group is 445 cells (normal = 550-1500) and the average CD4% is 28.6% (normal = 27%-53%). And, indeed, they all remain free of opportunistic infections and other indicators of AIDS.

    All of these patients started with CD4 counts of greater than 300. Dr. Bihari indicates that most patients with lower CD4 counts showed a decline in CD4 number and percentage over time, though much more slowly than untreated patients used to.

    > LDN Plus Antiretroviral Therapy
    Since the advent of HAART 5 years ago, Dr. Bihari has used it in combination with low dose naltrexone in all of his patients with lower CD4s. As of 2002, nearly all of his 175 patients in this category are on at least one protease inhibitor and either nevirapine or two nucleoside analogues. The group who began 5 years ago numbered 102 patients; there have been 3 dropouts since. There have been at least three interesting findings in this group:

    The viral load breakthrough rate in 5 years has been only 14% in the 102 patients who have been taking LDN along with HAART for that full time period. More than 85% have remained HIV RNA-PCR undetectable during this period. Reports from other treatment groups have shown an average breakthrough rate of 30-50% in the first twelve months, and 60-70% by the end of three years. The only difference in the treatment approach that could explain this is that all of Dr. Bihari's HIV patients are taking low dose naltrexone.


    Seventy-five percent of those on HAART and low dose naltrexone, including the few with viral-load breakthroughs, are showing a slow secondary rise in CD4s, which generally begins after 18 months on HAART. This late rise in CD4s in all cases has been persistent in all cases. In the 99 long-term patients, there has been a mean rise of CD4’s from 285 to 496 (87%). This is significantly greater than the rise seen with HAART alone. The medical literature does not appear to have studies showing this phenomenon in patients not on LDN.


    None of the more than 175 patients on protease inhibitors have developed any sign of lipodystrophy, except for four who stopped naltrexone. These are four patients who stopped naltrexone in their early months of HAART, all of whom began to develop lipodystrophy six to nine months later. All four eventually resumed naltrexone. Three experienced complete reversal of lipodystrophy signs after nine or ten months back on the medication. The other has shown significant movement toward reversal at twelve months. Dr. Bihari speculates about the relative role of high cortisol levels and low endorphin levels in the development of lipodystrophy. He suggests that LDN’s ability to raise endorphins to counterbalance the cortisol may be responsible for its protective role.

    > HIV/AIDS in the Developing World
    A new project has been initiated with the cooperation of Dr. Bihari. This aims to acquaint all of the developing nations about the potential of LDN in dealing with the AIDS pandemic.

    (Click here for The Developing Nations Project.)


    --------------------------------------------------------------------------------

    Noteworthy Cases
    Examples of patients with successful treatment outcomes,
    as of December 2001:

    (Note: patients listed started naltrexone at the 3mg dosage. Beginning November 2000, all patients switched to naltrexone 4.5mg at Dr. Bihari's suggestion.)

    V., a 47-year-old man, was diagnosed HIV-positive October 1989, but did not begin taking LDN until June 1992. In April 1992 he showed a CD4 count of 580 (CD4%=29). In July 1999, after 7 years on LDN with no antiretrovirals, his CD4 count was up, at 776 (CD4%=29.4). His general health status as of an April 2000 office visit to Dr. Bihari was good.

    M., a 53-year-old man, was diagnosed HIV-positive in July 1990. He started on LDN January 1991, with a baseline CD4 count of 742. More than 10 years later, his CD4 count was slightly higher, at 778. At his latest office visit to Dr. Bihari, in September 2001, he was found to have mild neuropathy and lymphocytosis. At no time has this patient taken antiretroviral medication.

    L., a 37-year-old woman, was diagnosed HIV-positive in March 1992, and began taking LDN 5 months later. Prior to starting on LDN, she took AZT for an unspecified period of time. Her CD4 level, as measured in April 1992, was 321 (CD4%=50.3). Her latest test results, as of June 1999, showed a CD4 level increase to 444 (CD4% had decreased to 42.9). She had never taken antiretrovirals. In her latest office visit to Dr. Bihari (January 2001), she was pregnant and doing well. She recently gave birth to an HIV-negative baby.

    S., a 40-year-old man, was diagnosed HIV-positive in 1992, and began taking LDN in December 1993, at which time his baseline CD4 count was 422 (CD4%=20). His latest lab tests, administered December 2001, after 8 years on LDN with no antiretrovirals, showed a CD4 count of 756 (CD4%=25). His general health status as of his latest visit to Dr. Bihari (December 2001) was excellent.

    G., a 48-year-old man, was diagnosed HIV-positive and began taking LDN in May 1997. Measured in March of 1997, his baseline CD4 count was 557 (CD4%=33). His most recent lab test, October 2001, showed a CD4 level increase to 718 (CD4%=42). Health status was good as of a November 2001 office visit. Note: This patient began taking the antiretrovirals Crixivan and Viramune at the same time he started on LDN, but stopped taking them at Dr. Bihari's suggestion after three and a half months.



    Example of patient on antiretroviral therapy having prompt response to lipodystrophy when LDN added (June 2002):

    M., a 53-year-old woman, not only had diabetes, which required a moderately high dosage of insulin (90 units daily), but also was suffering from lipodystrophy as a complication of her AIDS therapy. In early May, Dr. Bihari noted that he expected LDN would combat her lipodystrophy (which includes insulin resistance) and therefore would probably decrease her insulin needs. Three weeks later, he saw her again for the first time since LDN had been started. Her insulin requirements had dropped from 90 units/day to 20 units/day during those three weeks, and her "buffalo hump" (a swelling at the upper back/lower neck area characteristic of lipodystrophy) had regressed by two-thirds. Her swollen abdomen had begun to recede, enabling her, she said, to cross her legs "for the first time in a year".


    --------------------------------------------------------------------------------

    What Patients Say
    LDN Conference presentation (2006). William Way spoke on the LDN Advocates Panel at the April 2006 LDN Conference on the NIH campus in Bethesda, Maryland. He described having first tested positive for HIV 16 years ago—since that time he has used nothing stronger than nightly LDN to treat the HIV infection. During these many years he reports that his CD4 cell count has, for the most part, remained in a favorable zone, and he has been symptom free. In contrast to virtually any other person who has carried an HIV infection for many years, Mr. Way has never had to use antiretroviral drugs, thus avoiding the attendant expense, annoying schedules, and risk of side-effects. Mr. Way's entire talk can be viewed here.

    Recent reports (2005). Detailed reports from an HIV-infected patient, who has been taking only LDN for his disease for the past 12 months, present strong evidence for the efficacy of LDN in treating HIV. His comments are reprinted in the HIV/AIDS subsection of the linked page "What Others Are Saying About LDN" (his are the three messages dated 2005). We hope that all the developing nations that are struggling to treat their HIV-infected citizens will take note.

    Phone survey (2001). In November 2001, seven of Dr. Bihari's HIV-positive patients who take LDN without antiretrovirals were interviewed by telephone. Here are some of their responses to the following questions:

    How would you describe your experience with using LDN?
    How has it been beneficial?
    Are there any negative aspects?

    "Absolutely positive. There were really no other choices [when I was first diagnosed]. LDN gave me some hope. Over time, my [CD4] counts never dropped. I kept waiting, and they just never dropped. So far, it's been really great. I believe in LDN—it makes sense to me."
    "No negative aspects whatsoever. LDN has, I believe, kept my CD4 count from dropping—it has been the same since I started to take LDN (in 1991)… 300 to 350, in that range. I remember when I first started to take it, I felt very different—after a month I felt better all of a sudden. About that time my roommate said to me one day: 'You look so different; you look so much better; your face looks so healthy.' It's been very positive—and it's inexpensive. I believe it's been the major factor in keeping me healthy."
    "No negative aspects at all. My viral load has been stable ever since I've been diagnosed and taken this medication. It's been great—no side effects or anything negative about it; everything's been positive."
    "I'm basically doing pretty well without being on any of the protease inhibitors ever."
    "Sleep was difficult [on LDN] for 2 weeks or a month—I felt buzzy. I learned to take it closer to bedtime, which helped. Only for a short period was this a problem. Benefits: my viral load has regularly been undetectable or negligible. LDN has been very good for me, non-problematic, inexpensive. It seems like it's had a very good effect on my life."
    "No negative aspects. My [CD4] numbers have maintained—up around 800 or 900 since day one."
    "No negative aspects at all. LDN is what's helped me a lot over the years. I've been HIV positive for almost 15 years now, and have never been sick with any symptoms related to HIV. I think that's mostly because of LDN."
    (Click here for more from the November 2001 HIV patient interview.)


    --------------------------------------------------------------------------------

    Background
    > History
    LDN has been in use in the treatment of HIV/AIDS since the completion of a double-blinded placebo-controlled trial in 1986. The trial showed significant immune system protection from HIV in the group given the active drug.

    The development of LDN was based on several biological facts. One was the fact that naltrexone, which had been licensed in 1984 as an adjunct in treating heroin addiction, has the ability to induce increases in the endorphin levels in the body. Another was the fact that endorphins are the primary supervisors or (homeostatic) regulators of the immune system, representing 90% of immune system hormonal control. Ninety percent of the day's endorphins are produced by the pituitary and adrenal glands between 2a.m. and 4a.m.

    Dr. Bihari and his colleagues then showed that endorphin blood levels averaged less than 25% of normal in people with AIDS. These facts all provided the background for the discovery of the value of LDN in HIV/AIDS. The nocturnal production of endorphins allowed Dr. Bihari and his colleagues to experiment with small doses of naltrexone taken at bedtime in order to jump-start endorphin production. They found that LDN increased endorphin production when taken at bedtime in doses of 1.5mg to 4.5mg. Doses lower than 1.5mg had no effect on endorphin production. Doses higher than 4.5mg produced no more of an endorphin boost, but did block endorphins for significantly longer, thereby reducing the benefit of increased endorphin levels.

    Dr. Bihari and his colleagues carried out a placebo-controlled trial of low dose naltrexone in 1985-1986 in 38 patients with AIDS. This followed publication of considerable laboratory research in basic immunology done by Plotnikoff and others that had shown how endorphins play a central role in regulating the immune system. LDN was chosen for its ability to induce increased production in the body of two endorphins, beta endorphin and metenkephalin. A dose was chosen, 3.0 mg at bedtime, that raised endorphin levels without blocking them for more than a few hours. The elevated endorphin levels persisted for 20 to 24 hours.

    The 12-week trial showed a significant difference in the incidence of opportunistic infections. There were 5 such infections in 16 patients on placebo and none in 22 patients on the drug. Lymphocyte mitogen responses declined on placebo and not on the drug. Finally, the pathologically elevated levels of acid-labile alpha interferon, present in all 38 patients, declined significantly in the patient group that took LDN and did not drop in those on placebo.1,2

    (Click here for a complete report on the 1986 trial.)

    After the trial, Dr. Bihari began to use LDN in his private medical practice. He was able to do so because the drug is FDA approved for another use, which is the treatment of heroin addiction at a dose of 50mg/day. In 1995, he evaluated the results associated with the use of naltrexone in 158 patients. Only 10 were on antivirals. The results were quite striking. Patients who had taken the drug regularly as prescribed (compliant) showed no drop in CD4 cells. The average CD4 number in these patients before starting naltrexone was 358, and the average 18 months later was 368. The 55 patients who had not taken the drug, or had taken it only sporadically (non-compliant), showed a drop of CD4's from an average of 297 to 176 in 18 months. This represented a drop of approximately 80 per year, roughly the usual rate of drop in patients with HIV with no treatment. Thus, LDN had completely stopped the CD4 drop. This stabilization of CD4's was accompanied by an arrest of disease progression. The 55 non-compliant patients experienced 25 opportunistic infections, and the 103 compliant patients only 8. Survival was also significantly different between the groups. There were 13 deaths among the 55 non-compliant patients and only one in the group of 103 compliant patients. Some patients in this study had been on naltrexone for as many as 7 to 8 years, with no disease progression or CD4 drop and no evidence of resistance to the beneficial effects of the drug. None of the patients experienced side effects.

    (Click here for a summary of results from Dr. Bihari's private practice
    through September, 1996.)

    Many years later, in 1998, a relevant laboratory research paper was published by Sharp et al in the journal Biochemical Pharmacology. It demonstrated that activation of delta-opioid receptors of acutely infected CD4+ T cells significantly inhibited HIV expression in those cells. [Ed. note: activation of these receptors is one of the effects of the endorphins that are stimulated by taking LDN.] 3 (abstract)

    > The 1996-1998 Study
    In September 1998, Dr. Bihari reported on his retrospective, private-practice based, observational study of the effects of a combination of highly active antiretroviral therapies (HAART) and LDN on HIV RNA-PCR, CD4 levels, adverse reactions and clinical status in 85 patients with HIV/AIDS.

    The study was begun in August 1996 when nevirapine became widely available, 4 to 7 months after the availability of indinavir and two other new protease inhibitors. All 85 of the patients were already on LDN. Based on CD4 levels, clinical history and personal preference, 60 of the 85 were started on or were already receiving lamivudine (Epivir). Forty-nine were also on zidovudine (Retrovir) and 4 on stavudine (Zerit) with lamivudine. Twenty-five received indinavir, nevirapine and naltrexone without other antivirals. Treatment with naltrexone, zidovudine and lamivudine or stavudine always preceded the initiation of indinavir and nevirapine, by 3 to 15 months.

    The age range was 22 to 74. Ten were women and 75 were men. Thirteen were African-American, 6 were Latino, and 2 were Asian-American. The mean time from initiation of indinavir and nevirapine therapy to the most recent laboratory results was 20 months. Half of the group had been on this combination for 23 months when the most recent labs were done. Patients who were on O.I. prophylaxes before starting these new antivirals were all continued on them, no matter how great the magnitude of rise in CD4 number and CD4 percentage. All patients were started on 1000 mg of indinavir every 8 hours. This was raised from the usual 800 mg every 8 hours to compensate for nevirapine-induced lowering of indinavir blood levels.

    Seventy-five patients became PCR undetectable in 4 weeks and remained so. Six never reached undetectable levels. Three did reach undetectability on only one test but then quickly rose back into the detectable range. These 9 acknowledged significant and prolonged lapses in compliance with the indinavir regimen. Only one compliant patient had a sustained suppression of viral load to undetectable (for 6 months) followed by plasma viremia. Seventy-five had no detectable HIV since the first month's test.4

    There was not a single major opportunistic infection in the 85 patients. One had an episode of shingles. None had thrush. All but one patient remained at their ideal weights or higher. None died or was lost to follow-up. Most patients noted a significant increase in energy, appetite and mood after adding the antiretrovirals.

    Only one case of the lipodystrophy syndrome was observed in this patient group. There were, except for this one patient, no changes in fat distribution, in serum triglycerides, in blood glucose or significant rises in serum cholesterol. Since the range of incidence of this syndrome in other studies of patients on protease inhibitors varies from 11% to 35%, this appeared to be a very unusual finding. The one patient who was an exception supported the likelihood that LDN was responsible for the general protection against the lipodystrophy syndrome.

    This patient was on indinavir, nevirapine and LDN for 15 months, with a rise in CD4's, undetectable viral load and no lipodystrophy. He then moved to the west coast of Canada where he was unable to obtain naltrexone, which is not yet a licensed drug in Canada. Because of his sustained viral-load suppression and positive feelings about the new antivirals, he felt the naltrexone was not crucial and discontinued it. About 8 months after stopping low dose naltrexone, he began to develop the changes in body shape associated with lipodystrophy. These physical changes were accompanied by a sharp rise in serum cholesterol, triglycerides and glucose.

    Later, Dr. Bihari learned of three other patients who had stopped LDN after starting HAART, then developed lipodystrophy six to nine months later. As mentioned above, three of these four patients experienced clearing of lipodystrophy after nine to twelve months back on LDN.


    --------------------------------------------------------------------------------

    Footnotes
    Bihari B, Drury F, Ragone V et al. Low dose naltrexone in the treatment of AIDS. IV International Conference on AIDS. Poster 3056. Stockholm, June 1988.
    Bihari B, Drury F, Ragone V et al. Low dose naltrexone in the treatment of AIDS: long term follow-up results. V International Conference on AIDS. Poster M. C.P. 62. Montreal, June 1989.
    Sharp BM, Gekker G, Li MD et al. Delta-Opioid Suppression of Human Immunodeficiency Virus-1 Expression in T Cells (Jurkat). Biochemical Pharmacology, Vol. 56, pp. 289-292, 1998. Read the abstract.
    Deeks SG, Beatty G, Cohen PT et al. Viral load and CD4+ T Cell changes in patients failing potent protease inhibitor therapy. Fifth Conference on Retroviruses and Opportunistic Infections. Abstract 419. Chicago, Feb. 1998.

    --------------------------------------------------------------------------------
  17. undcvr

    undcvr Senior Member

    Messages:
    760
    Likes:
    113
    NYC
    Hey Pinky, glad to know you slept well. You are sounding better too. The sleep could have been from the Magnesium too, it helps with insomnia.
    It helps me sleep well too.
  18. VillageLife

    VillageLife Senior Member

    Messages:
    674
    Likes:
    36
    United Kingdom
    god bless you,
    I hope it all works out for you.
    love kate xxxx
  19. illsince1977

    illsince1977 A shadow of my former self

    Messages:
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    21
    LDN made my insomnia even worse. I hope it is helping your sleep, Pinky. That would be a blessing.
  20. citybug

    citybug Senior Member

    Messages:
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    36
    NY
    Hi Pinky, I'm not as severe. I've been going out to doctor once a week or every other, and moving around apt. but have many of the symptoms on your list. I've had the burning feet for years. It never occurred to me to use frozen packs, but I would be afraid they would use up more atp warming body. Hate the short of breath. I'm using the heart rate monitor and sitting down on the floor all the time when not lying down. I'm upping the salt and fluids. Fluids seem important with other meds. It's hard to keep refilling glass. I'm trying to start using pitcher.

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