PATENT NO. US5846961
MULTI-FACETED METHOD TO REPRESS REPRODUCTION OF LATENT VIRUSES IN HUMANS AND ANIMALS
Inventor Van Dyke; Knox
Filed date June 7, 1995
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TABLE 4
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EFFECT OF ANTIRETROVIRAL THERAPY ON RETROVIRUS-INFECTED CATS
Age Sex Name.........Assay Symptoms............Assay
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8 F Champagne ... FELV(+), hair loss, lost teeth FELV(-), FIV(+) FIV(-)
8 M Precious ...... FELV(+), vomiting, dental FELV(-), FIV(+) problems FIV(-)
9 F Missy ........... FELV(+), Bloody diarrhea FELV(-), FIV(+) dental problems FIV(-)
11 M Sampson ... FIV(+) Vomiting, gum red FIV(-)
8 M Josey .......... FELV(+) teeth loss, no FELV(-) appetite, lung problem
10 M Patch ........ FIV(+) poor appetite FIV(-) lethargy
12 M Bud .......... FIV(+) weight loss, no FIV(-) appetite
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notes:
1) One cat with FELV(+)/FIV(+) died without the treatment as a control.
2) Treatments: Cats were injected intramuscularly with 20 mg DEPOMEDROL (antiinflammatory steroid) and dispensed with 1,200 mg powdered Nacetyl cysteine(NAC), 200 IU of Vitamin E, 500 mg of Vitamin C and one PET TAB/day.
3) It takes from 3 weeks to 6 weeks for the cats to turn retrovirus positive reaction to negative after the treatment.
4) The symptoms of Champage, Precious, and Missy such as dental problems bloody diarrhea, and loss of appetite completely subsided after the treatment with steroids/antioxidants. The symptoms of Sampson such as vomiting, gum disease, and loss of appetite completely reversed after the treatment. Josey's symptoms of lung problem, loss of appetite, and gum infection cleared up following the treatment. The cats were maintained on PET TABS following the treatment with steroid/antioxidants.
5) At the conclusion of the test all cats remained FIV or leukemia virus negative.
6) Blood was drawn for analysis from four of the cats treated (Sampson, Josey, Patch, and Bud). The analysis included cell cultures, mitogen stimulation, and polymerase chain reaction assay for the retovirus. All tests indicated the cats were fully cured as none indicated any sign of the virus.
These cat experiments are the first to demonstrate that AIDS can be cured in an in vivo model.
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If you access on the internet "US Patent" look to find a website that is free that will give you patent information.
US5846961: Multi-faceted method to repress reproduction of latent viruses in humans and animals.
You can then check detail to view the whole patent information. There are four diagrams with patent.
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COMMENTS
I wanted to show this patent information and results with FIV infected cats reduction of symptoms.
The patent US5846961 shows the use of treatment process that lasted one to two months with N-acetyl cysteine (NAC) and high dosages of Vitamins C, E and A and periodic administration of anti-inflammatory steroids.
Pet Tab given daily
I have shown the results.
Table 2 - Preferred MDR Embodiment
Copper (as cupric oxide) 2mg
Zinc (as Zinc oxide) 15 mg
iron (as ferrous salt) 18mg
selenium (sodium selenate) 25 mcg
The problem with antiinflammatory drugs like Depomedrol is the suppression of the immune system and side effects. Depomedrol should be used with an antibiotic. There are some opportunistic infections that treatment is useful for.
There has been a recent article on the treatment of FIV in cats with a DEPOMEDROL-type steroid, and they concluded it was detrimental for long term.
DEPOMEDROL is a glucocorticoid.
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I received an e-mail from a pet owner and his vet is giving an injection once a week for a month-then once every two weeks for four weeks after that and then once a month.
I suggested chop the vitamins up and place once a day in a glass with some water and use a syringe to put the mixed liquid into felines mouth. Usually I get down on my knees behind the cat to do this. Look at "holisticat.com/ffeed 'Force-Feeding' ". You can purchase a syringe at a pharmacy or maybe get one from your vet.
PET TABS are part of formula required. PET TABS was manufactured by Smith-kline Beecham and now Pfizer. Supposed to contains vitamin A other vitamins and minerals. Ask your vet about them.
Required also is NAC 1200mg
Vitamin C 500mg
Vitamin E 200IU
E-Mail Wednesday, April 10, 2002
Subject: Pr Andrieu
Dear Dr Finlow,
Thank you for your e-mail of Feb 2001 (!). I am presently starting writing the paper reporting the 10-year results of our PDN trial. It is a pleasure for me to summarize our results for you.
Prednisolone (+/- 0.4 mg/kg) was started in 44 pts (mean CD4 cell count 441 CD4/ul) between July 1rst, 1992 and Feb. 23rd 1993. Eleven of them were at that time under Zidovudine which was stopped between the 6th and 18th of PDN.
All pts received PDN for two years at the above-mentioned dose (except 1 who withdraw from the trial at 8 months with increase CD4 cells). As from the 3rd year to now, all patients whose CD4 cells level remained over their initial count remained under PDN without any antiviral drug; on the other hand, all patients whose CD4 cells dropped under their initial level were asked to stop PDN (over 2 to 4 months) and to switch to the antiviral therapy available as that time (reverse transcriptase inhibitors alone until April 96 and HAART after this date).
1. Effects of PDN on viral replication.
Viral replication remained stable over the 2 years where viral load was measured each other month in all pts.
2. Effects of PDN on CD4 counts.
After initiation of therapy, CD4 cells increased very significantly within 2 weeks from a mean of 441 to 580 cells/ul. CD8 cells also increased but only when they were initially lower than 1.000 cells/ul.
The mean CD4 cell count of the pts remained increased and stable for 6 months; it then dropped down slowly to reach initial level by 2 years.
As from the 3rd year, PDN was stopped in all pts whose CD4 cell count decreased under their initial level.
Overall, at 2 years 43% of the patients remained with an increased CD4 cell count; at 5 years 18% of the pts remained with increased CD4 cells. Presently, we still have 2 patients under PDN with CD4 cells over their initial level: both of them have thus received almost 10 years of PDN without any antiviral therapy.
When looking at a control group made of 74 pts with the same CD4 cells and viral loads who did not received any treatment before their CD4 cells dropped under initial levels, the % of pts maintaining spontaneously their CD4 cells over entry levels were 5% at 2 years and 0% at 5 years (P log Rand greater than 0.0001).
Interestingly, results of PDN therapy can be predicted from initial viral loads. The mean CD4 cell count of the 21 pts with greater than 30,000 copies/ml dropped under initial level after a year of PDN. In contrast, the subgroup with an initial viral load less than 30,000 copies/ml remained with an increased mean CD4 cell count between the 3rd and the 10th year of PDN.
3. Effect of PDN on activation markers and proimflammatory cytokines (AMPC).
AMPC dropped very quickly within the 2 weeks following the onset of PDN. They remained low (i.e. +/- in the normal range) in all the pts whose CD4 count remained increased whereas AMPC re-increased in the pts whose CD4 cells re-decreased.
4. Effects of PDN on opportunistic infections and tumors. Three AIDS episodes occurred 12, 20 and 22 months after the onset of PDN but PDN was stopped since 8, 8 and 16 months; at the timeof AIDS, CD4 cells/ul of these 3 patients was 101, 29 and 3 and their initial vital load was greater than 30,000/ml. As from the third year, no AIDS episode developed in patients under PDN (i.e. with a CD4 greater than or equal to initial levels). In the control group, AIDS developed in 12 pts within the first 2 years of follow up.
5. Side-effects of PDN
All pts were given vit D and Ca++ as well as K+. Over the first 2-years, the took 1 kg. Cutaneous side effects of PDN were mild and/or developed very slowly; no buffaloneck was observed. Over two years the mean blood pressure increased not significantly; however 2 pts were put under B blockers. No infection or any other side effect occurred.
6. Mechanism of PDN activity
In 1995 we published a paper in "AIDS" (see Pub Med) where we showed that PDN had a strong anti-apoptotic effect; we are now studying more carefully the activityof PDN on the trio Dendritic cells-CD4 and CD8 cells.
6. Background and prospects
We started our clinical and biological work in the field of HIV infection in 1985 when we suggested that Cyclosporin (CSA) could paradoxally be an interesting drug in HIV infection (see Pub Med Andrieu J.M. 1986, 1988, 1995). Following this research avenue, Pantaleo and coll. have now shown (JCI March 2002) that CD4 cells of primo-infected pts increased very rapidly under CSA plus HAART while they increased slowly under HAART alone.
In 1995, after haing published the one-year results of the PDN study (see Pub Med 1995), I prepared a double blind randomized trial for naive patients with CD4 cells greater than or equal to 300 and less than 500/ul {Arm A PDN 0.4 mg/kg/day, Arm B placebo}. The end-point was a decrease in the CD4 cell count of less than or equal to 20% under initial level (at 2 successive time points within 2 months). When reaching the end-point, whatever their arm, patients should start HAART (and slow stop PDN after a decrease). Unfortunately, when this protocol was submitted to our French agency on AIDS research (ANRS) (at a time when Protease Inhibitors were blaned to arrive and excited very much our medical community), 8 experts agreed but 9 diseagreed with the protocol which was thus not opened!
Since that time, I have given PDN on an open basis to the patients with less than copies/ml who desired to postpone their entry in HAART. All these patients rapidly increased their CD4 counts within 2 weeks and they remain with increased CD4 cells since months to years without any other treatment.
In case where you would be interested to mount a phase III randomized trial, 25 to 30 patients in each arm would be sufficient for the demonstration (and less if you take only the patients with VL less than 30,000/ml).
Let me know your opinion on all these interesting matters, and try not to wait a year (as I did) to keep in touch with me!
Sincerely yours.
COMMENT: See www.biomedcentral.com/1741-7015/2/17
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Dr Albrechi Ulmer (2004) reported on 56 antiretroviral-naive patients treated with prednisolone 5mg daily for between 6 months and 11 years, in whom CD4 cell counts rose by an average of 51.6 cells per year.
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Low-dose prednisolone reduces CD4+ T cell loss in therapy-naive HIV-patients without antiretroviral therapy.
Albrecht Ulmer, Bertisch-Mollenhoff, Frietsch B, Muller M., Eur J Med Res. 2005 Mar 29;10(3):105-9, Stuttgart, Germany. albrecht.ulmer@gmx.de
BACHGROUND: A favorable development of CD4+ T cells was noticed in therapy-naive HIV-patients without antiretroviral therapy (ART) taking 5 mg prednisolone daily. Based on these encouraging observations, prednisolone therapy in further HIV-patients without antiretrovrial therapy was initiated.
OBJECTIVE: To evaluate the effect of low dose prednisolone on therapy-naive HIV patients without antiretroviral therapy.
METHODS: A retrospective analysis has been conducted comparing the development of CD4+ T cells, viral load and clinical outcome in all therapy-naive HIV-patients with (n=65; CD4 more or equal 300/microl) or without (n=136; CD4 more or equal 300/microl) prednisolone for more or equal 6 months.
RESULTS: After 3 years, therapy-naive patients on prednisolone therapy showed a CD4+ T cell increase of +50.1/microl whereas in the untreated group a decrease of -186.1/microl (p=0.0021) was noted. After 12 months, nearly twice as much untreated patients experienced a first-time CD4 T cell loss of more 100/microl or initiation of HAART due to clinical development compared to prednisolone-treated patients (65.1% vs 35.0%).
CD4 T cell increase was associated with viral load at baseline: Patients with lower viral loads at baseline (less 30,000 copies/ml) showed a favorable development with statistically significant less drop-outs (defined as HAART-onset and/or prednisolone discontinuation for the prednisolone group) than patients with higher viral loads at baseline in the first 3 years in the prednisolone group
Conclusion: Low dose prednisolone seems to be associated with a stabiliztion of CD4+ T cell count in therapy-naive HIV patients resulting in a pronounced prolongation of the potential time without HAART for many HIV patients.
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Prednisolone can have undesired effects, such as causing a flare-up of diseases such as thrush or herpes. The drug also been associated with bone damage.
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Low-dose prednisolone treats HIV-patients during structured therapy interruptions (STIs)
June 22, 2005 Eur J Med Res
Albrecht Ulmer, Bertisch-Mollenhoff, Frietsch B, Muller M., Eur J Med Res. 2005 Jun 22;10(6):227-32. Schwerpunktpraxis, Stuttgart, Germany. albrecht.ulmer@gmx.de
BACKGROUND: A favorable development of CD4+ T cells was firstly noticed in therapy-naive HIV-patients without antiretroviral therapy (ART) taking 5 mg prednisolone daily. This observation led to the prescription of prednisolone during structured therapy interruptions (STI).
OBJECTIVE: To evaluate the effect of low dose prednisolone on pre-treated patients during STI.
METHODS: A retrospective analysis including all pre-treated patients with prednisolone therapy fo more or equal 6 months during STI has been conducted. The patients with prednisolone onset right at the beginning of STI (n=95) were compared with all patients without Prednisolone therapy during their first 6 months of STI (n=49). Patients with prednisolone were divided into two subgoutps: the ongoing STI-group and the patients with ART-restart.
Additionally, the development of all 33 patients from the control group having started prednisolone later during STI was documented. Irrespective of the time of initiation of prednisolone therapy during STI, the development of CD4+ T cells in all patients with prednisolone for more that 12 months during STI was analyzed. (n=108)
RESULTS: The mean daily CD4+ T cell decrease during STI was significantly less pronounced in the prednisolone-group (-0.50 vs. -0.74 cells/day; p=0.0361). The daily CD4+ T cell decline of the 33 patients from the control subgroup including patients with a later onset of prednisolone therapy was only -0.11 during a mean time of 715 days under prednisolone.
The CD4+ T cell count of the STI-patients treated with prednisolone for more than 12 months (n=108; mean: 837 days +/-64.6 (366-1,756)) decreased from 677/microl to 504/microl. -51 of 81 patients (63%) included in 2-year-analysis showed stable CD4+ T cell counts (mean daily CD4+ T cell decrease: 0.08) and continued ART interruption.
CONCLUSION: This retrospective evaluation provides evidence that low dose corticosteroids are associated with less of CD4+ T cell count in pre-treated HIV patients resulting in prolongation of the potential time of structured treatment interruptions for many HIV patients.
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PATENT 6172053
Inventor Fubunan; Ruben G
Injection viral treatment
The present invention relates to a therapeutic composition and formulation for the treatment of viral diseases such as Dengue fever and influenza. More particularly, to therapeutic preparation comprising substantially water soluble, local anesthetic of the ester type, procaine hydrochloride and a water soluble glucocorticoid, dexamethasone sodium phosphate.
Case 6 May, 1999 CD3=898;CD4=287;CD8=525...July CD3=1601;CD4=559;CD8=1019
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Chronic Innate Immune Activation as a Cause of HIV-1 Immunopathogenesis
Suggests that the chronic activation of plasmactoid dendritic cells (pDC) by actively replicating HIV-1 may contribute to at least three of the major signs of HIV-1 disease: 1) suppression of CD4 and CD8 T cell responses; 2) preferential apoptosis of CCR5-expressing CD4 T cells; and 3) induction of an apparent state of phenotypic T cell activation.
Corticosteroids depress IFN-alpha-producing plasmactroid dendritic cells in human blood
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Low-dose interferon-a treatment for feline immunodeficiency virus infection
E. Pedretti, B. Passeri, M. Amadori etc
Veterinary immunology and immunopathology accepted 15 August 2005
Abstract
Feline immunodeficiency virus sustains an AIDS-like syndrome in cats, which is considered a relevant model for human AIDS. Under precise enrolment requirements, 30 naturally infected cats showing overt disease were included in a trial of low-dose, oral human interferon-a treatment. Twenty-four of them receieved 10 IU/Kg of human interferon-a and 6 placebo only on a daily basis under veterinary supervision. The low-dose human interferon-a treatment significantly prolonged the survival of virus-infected cats (p greater than 0.01) and brought to a rapid improvement of disease conditions in the infected hosts. Amelioration of clinical conditions was neither correlated with plasma viremia, nor with proviral load in leukocytes. A good survival of CD4+ T cells and a slow increase of CD8+ T cells were also observed in human interferon-a-treated cats. Interestingly, the improvement of the total leukocyte counts showed a much stronger correlation with the recovery from serious opportunistic infections. As shown in other models of low-dose interferon-a treatment, there waws a rapid regression of overt immunopathological conditions in virus-infected cats. This hints at a major role of interferon-a in the control circuits of inflammatory cytokines, which was probably the very foundation of the improved clinical score and survival despite the unabated persistence of virus and virus-infected cells.
Alfaferone was used
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Multiferon...Human natural interferon-a made is Sweden
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Alferon
Potency: Each 1ML vial of Alferon contains 5MU (short for 5 million Internation Units) of interferon.
Dosage: 50 IU/ML daily
Administration: Alternating 7 days of daily treatment followed by 7 days of no treatment. Apply over gums from the lateral rim of the lips. Do not put in food or give a treat immediately following administration. Using a 1ml syringe give more control to apply over the gums, than a large one
Option for dilution:
Dilution using "eye rinse" Advantage: Very easy and inexpensive. It can be stored in the refrigerator indefinitely due to the preservatives in the saline. Disadvantage: Lower dose mixture; the preservative in the eye rinse could irritate oral tissue over time
Diluting: Go to Wal-Mart and purchase their cheapest eye rinse (saline solution). "The brand name is Equate and is labeled for use in rinsing soft contact lenses." Add the 5 million IU vial to a bottle of 355 ml saline so there will be 14,000 IU per ml. Label this bottle as the "Mother" bottle. Then transfer 1.0 ml to another bottle of saline (355 ml) and you will have a "working" bottle of 40 IU per ml. Keep the working bottle in your refrigerator and freeze the the mother bottle. Do not worry about stability. If you decide to freeze syringes, do not hesitate to reuse them.
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This is example of less effective type of interferon
SURVIVAL OF SYMPTOMATIC FELV OR FELV AND FIV POSITIVE CATS TREATED WITH A RECOMBINANT FELINE OMEGA INTERFERON
Mahl P, Maynard L, Karine De Mari K, and Lebreux B
A study was designed to assess the efficacy of a recombinant feline omega interferon (iFeIFNw) in the treatment of symptomatic FeLV or FeLV and FIV positive cats. In a multicentric, controlled, randomised and double blind clinical field trial, 48 FeLV or FeLV and FIV test cats were included with general clinical signs and/or chronic granulimatous stomatitis. 28 cats were subcutaneously administered 1 million units (MU) interferon per kg b.w. once a day for 5 days and 20 cats received a placebo. Symptomatic treatment including antibiotherapy was allowed in all cats. Cats were clinically observed for 6 months and death date was recorded if applicable. Efficacy was assessed through the survival probabilities which were calculated by the KAPLANMETER method and compared by the LOGRANK test. 13 (46%) cats died during the observation period in rFeIFNw group and 15 (75%) in the placebo group. Comparison of the survival curves showed a statistically significant difference between groups (p= 0.0331). Safety of the product based on clinical examination was excellent. After 5 SC infections of 1 MU/kg rFeIFNw, the survival probability over a 6-month period of FeLV or FeLV and FIV symptomatic cats was 2.2 times higher in the treated cats.
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CASE STUDY; FIV AND FIP
Unilateral uveitis associated with two virus in an ageing cat
An interferon (a and 0 IFN) and dexamethasone-based treatment resulted in an asymptomatic period of over a year in a twelve-year old cat with acute unilateral uveitis, jaundice and haemolytic anaemia
By Dr. Vet. Patrick Lazard
This article presents the case of an elderly cat that survived for over a year with the administration of an injectable recombinat omega interferon of feline origin and a liquid oral form of alpha 2a recombinant interferon of human origin.
http://vetinterferon.nexenservices.com/HTML/inc_pdf140.pdf
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COMMENT ON VETERINARIANS
I find that some veterinarians solution to treating FIV is to put the cat to sleep. In one e-mail I received the veterinarian told the pet owner that had a FIV mother cat that just had kittens a few days before to also put the kittens to sleep.
On transmission: 50% of kittens infected from acutely infected mother; 5% infected from chronically infected mother.
One book I read by veterinarian had on treating FIV was to put the cat to sleep.
I am not trained in medicine but in data processing. I spent 40 years gathering information to create systems that were put on a computer. I retired in May, 1999.
I am trying to get out information on this webpage on the current information available on the subject of FIV.
Too often veterinarians are in denial even when faced with scientific evidence that is different than what they thought.
Too often they do not have the latest research information available to make a sound decision. Research on AIDS is a fast changing field. But it takes time for it go through the medical community.