יש פתרון למחלת האידס. אפשר לקבל טיפול. אחרי שלושה חודשים לחזור לחיים סדירים. בלי קוקטייל. בלי תרופות. בלי טיפולים. לחזור ולהיות אדם רגיל. אדם מתפקד. אדם שלא יראו כלל שהיה חולה. אדם מאושר. אדם שיכול לחזור לחיים תקינים. ואף להוליד ילדים בריאים.
להלן החומר באנגלית. בתוך כמה חודשים נתרגם את החומר לעברית.

ARMENICUMS is a highly promising drug for treatment of HIV infection and AIDS-associated diseases.
ARMENICUMS has been tested in animals and has been shown to be safe and effective against wide range of bacterial and viral diseases.
ARMENICUMS reduces viral load (amount of HIV in the blood), increases CD4(T) cell count, and greatly improves quality of life.
ARMENICUMS means more benefit with less side effects.







Address to audience

DEAR FRIENDS



It is a pleasure to state that "Armenicums" pharmaceutical company accomplished an important step towards the human beings challenge to successfully fight against the "alien species", viruses. Regardless of future need in "Armenicums", it is already obvious, that it will forever occupy an empty niche on shelters of drug stores. It is a niche for a new substance which brings an enormous, as was thought before, amount of Iodine in the body without any harm for animals and human beings. Well-known antiviral effect of Iodine is delivered through the substance, which safely controls the process of Iodine elimination, when gets the blood by direct infusion. Alternative therapy, so long expected for infected with different viruses, is under the number of trials to make it available for a broader patient’s population. Available therapies with the range of side effect and group of patients, which did not benefit from traditional approaches, make "Armenicum" even more popular for the first beneficiaries.

Although, we are young enterprise, we are already rich with our arsenal of several alternative approaches for important problems that men still face today. But nevertheless, working in different directions with different active substances we are mostly focused on an antiviral drug "Armenicums", which is our challenge and our pride.
We have certainly overcome a fist stage of self-doubts and right now we are on a stage of transparent and open relationship with the world. We are ready to bring our voice as argument and share the experience we gathered, when being in an alternative experiment. We see essential benefits for patients taking "Armenicum". We offer you to argue but not just deny.
Your attitude is very important for us in order to overcome all barriers and reach the truth.







Sincerely yours,
Levon Gevorkian
The Head of Armenicums Project




Alex Levin
President
The world Armenicums project







General information

HIV-infection is a slowly but inevitably progressive immunodeficiency state developing in the result of the contamination with HIV-causative agent and leading to a number of fatal complications. The later clinically manifested stage is referred to as acquired immunodeficiency syndrome (AIDS).

HIV-infection pandemy has left the borders of one country, one profession and even the medicine in whole within the last two decades. According to the assessments of the UNAIDS experts by the end of 2003, the statistical quantity of children and adults with HIV/AIDS will be 40 million (according to unofficial data – 150 million) among them 2.7 million are children and 17.6 million are women. Initiating unprecedented epidemic, the disease has been registered in more than 200 countries, 25million people have died. During the first months of the current year approximately 14000 new cases of HIV-infection were registered daily in the world, at that, more than 95% of which were registered in developing countries.

There is a serious risk in AIDS spreading in Armenia, too. As per the 31st of August 2006, 415 cases of HIV-infection were registered. 97 females and 8 children were among the registered HIV-infected patients.

Current HIV-infection treatment regimens include combination therapy with several antiretroviral drugs, administered orally, and last indefinitely long. Therapy monitoring first of all is based on the viral load (VL) parameters. To reach and keep VL non-detectable level isn’t always possible. Moreover, there is a classification of therapeutic failure types. At last, HIV VL decrease up to non-detectable level is not accompanied with the inhibition of virus replication, causative agents of associated/opportunistic pathologies, and unfortunately does not suppose immune system normal functioning.

In compliance with the contemporary rules of clinical trials conduction, viral load, CD4+-T lymphocytes count, and patient’s quality of life must be present among anti-HIV drugs efficacy criteria by all means.

In 1994 by sponsorship of Mr. Levon Gevorgyan, Honorary Doctor of NAS of the RA, Head of “Armenicums” project, a creative scientific-research group at the head of academician Emil S. Gabrielyan, the scientific supervisor of “Armenicums” project, Director of Drugs and Medical Technologies Agency, was established in the Republic of Armenia with the aim of elaboration and study of a new antiviral drug which displays pronounced non-specific activity towards a wide spectrum of DNA- and RNA- containing viruses, including HIV1 and HIV 2.

In 1998 the drug “Armenicums” was elaborated and declared as a concentrate for intravenous infusion, possessing a wide spectrum of antiviral, antibacterial and immune-modulating activity and displaying pronounced activity towards HIV-infection.

The drug “Armenicums” is an iodine-lithium-organic polymers complex in water solution of electrolytes. Iodine exhibits bactericidal, fungicidal, protozoacidal and cysticidal activity. However, due to its high toxicity the spheres of iodine solutions usage are limited. Iodine, available in the molecules of bio- and synthetic polymers, both keeps and strengthens its anticeptic, antiviral and fungicidal properties completely. The complex of lithium-iodine-organic polymers provides the low toxicity, controlled diffusion of active components, prolongation of action systemic immune-modulating effect on the activation processes, differentiation, apoptosis and production of cytokines by lymphocytes and monocytes.

A wide spectrum of biological action is a very valuable property of iodine-polymers. They are active towards Gram-positive and Gram-negative microbes, pathogenic yeasts and viruses, at that maintaining the wide spectrum of iodine as an antiseptic. An antiviral activity of iodine-polymers must be specially mentioned as far as all antibiotics and chemical-therapeutic drugs are not effective towards viruses.

Pre-clinical studies of the drug “Armenicums”, conducted in the Republic of Armenia on 4 kinds of animals, and clinical trials on more than 400 HIV-infected patients being conducted since 1998 and not only in Armenia but in other countries as well, confirmed the declared properties of the drug.

In the result of clinical trials, below-listed main conclusions of Armenicum effect on HIV-patients’ health status are made:

1. Armenicums significantly improves quality of life in the following dimensions: overall health, physical function, role function, social function, cognitive function, pain, mental health, energy/fatigue, health distress, quality of life, health transition.
2. It decreases HIV-1 viral load.
3. It improves the immune status, evaluated by changes in T4-lymphocytes count and integral surrogate markers.
4. It leads to regression of some dermatological diseases, such as acne vulgaris, folliculitis, ostiofolliculitis, piodermitis, warts, condilomatosis, pityriasis versicolor, seborrheic and allergic dermatitis, neurodermitis, psoriasis, parapsoriasis, eczema, recurrent herpetic infection.
5. It improves memory, including professional speech, its sensible sequence, movement coordination, including the gait, as well as decreases severity of radicular syndrome and sleep disorders in patients with encephalopathy.
6. The drug “Armenicums” does not cause resistance in human organism which is one of its main properties.

The new clinic of Armenicums Project was founded in December 1999. It is a unique scientific and medical center which meets all the latest demands of contemporary medicine. The up-to-date laboratory equipment makes possible to perform all clinical, biochemical, serological, bacteriological, immunologic and virologic tests. There are 27 well-furnished wards, 2 Lux rooms, a big injection hall, a room for intensive therapy, small bandage room, fitness center in the hospital.

The central heating and air-conditioning system makes it possible to maintain stable temperature during whole year. The clinic is provided with multi-language and professional staff. The clinical center CJSC “Armenicums” is one of the best in CIS countries.

2 issues of scientific articles devoted to experimental and clinical studies of the drug, were published in Russian and English which is not only of great scientific-theoretical interest but of applied interest as well. Several articles and abstracts concerning the discussion of definite properties of the drug are published in the materials of 6 international conferences/symposiums.

The drug “Armenicums” is registered in the Republic of Armenia in accordance with the “Guidelines of Accelerated Approval”, worked out in FDA (Food and Drug Administration) of the USA and in EMEA of the European Union, for the drugs, directed for treatment of serious and life-threatening diseases.

Armenicum is protected by the patent N 949 of the Republic of Armenia, issued on the 10th of June 2001.

Clinical trials of the drug “Armenicums” are being conducted in some countries of the world, such as Ukraine, India as well as in some countries of African continent, particularly in Democratic Republic of Congo, Zambia, Liberia.

Application for registration of the drug “Armenicums” has been presented in the following countries: Russia, Ukraine, Greece, Democratic Republic of Congo, Liberia, Zambia, Zimbabwe, SouthAfricanRepublic, India and others.

In order to register and invest Armenicums in pharmaceutical markets clinical trials of Armenicums are being conducted in different countries Armenicums was registered in Democratic Republic of Congo and Liberia. Clinical trials of the drug “Armenicums” was carried out in Russia. Armenicums was registered in Russia on the 10th of February 2006 as well as in Ukraine on the 11th of December 2006.

In 2000 an international application for patenting Armenicum in 83 countries /PCT/AM00/00002, 24.11.2000/ was presented, and in the result we have got Eurasian patent N 004203, issued 26.02.2004, which is valid in 9 countries, including Russia. Ukraine, India and ARIPO-countries, including 12 African countries, have entered the national phase of patenting.







INSRUCTION FOR USE



Main physicochemical properties
Blue-violet liquid with specific odor, pH 3.5 - 5.5, density: 1.05-1.07, relative viscosity: 1.04-1.28, osmolarity: 285-315 mOsm.

Each vial (20ml) contains:
Iodine 0.16g;
Potassium iodide 0.24g;
Lithium chloride 0.004g;
Polyvinyl alcohol 0.06g;
Dextrin 2.0g;
Sodium chloride 0.18g;
Water for injection up to 20.0 ml.

Pharmaceutical form
ATX code J05AX. A concentrate for preparing an infusion solution.

Pharmaceutical group
An antiviral drug active against human immunodeficiency virus (HIV).

Mechanism of action
The mechanism of Armenicums action consists of both the direct and indirect anti-HIV action of its components as well as of the action of iodine-lithium-organic polymers complex as a whole. Iodine molecules and cations in the composition of Armenicums display pronounced non-specific activity towards a wide spectrum of DNA- and RNA-containing viruses, including HIV1 and HIV2. Iodine exhibits bactericidal (including antibiotic resistant Gram-positive and Gram-negative strains), fungicidal, protozoacidal and cysticidal activity as well. Lithium ions competitively displace magnesium ions, i.e. the co-factors of HIV reverse transcriptase and inhibit the virus replication in the infected cells. Polyanion complex of iodine- α- dextrin selectively interacts with CD4+-receptors of T-lymphocytes and inhibits the interaction of HIV gp120 with specific receptors, blocking the initial stages of CD4+ T-lymphocytes infection, syncytium-formation and transmission of HIV from infected cells to non-infected cells. The complex of lithium–iodine-organic polymers provides the low toxicity, controlled diffusion of active components, prolongation of action, systemic immuno-modulating effect on the activation processes, differentiation, apoptosis and production of cytokines by lymphocytes and monocytes.

Resistance to the drug
Iodine in the composition of Armenicum contributes not only the non-specific anti-microbial effect but the decrease of the probability of generating resistant forms of causative agents as well. Bacterial and viral resistance to iodine and iodine containing drugs has not been described yet.

Pharmacokinetics
Pharmacokinetics, studied by the concentration of iodide-anion in the blood and urine, indicates the rapid elimination of free iodine from the blood in the period of half-elimination equal to 4.9 hours: distribution volume is nearly 30% of body weight. The rate of infusion does not influence on pharmacokinetics of iodide-ion in the blood. Up to the 13% of the administered dose is eliminated with urine and the residue is eliminated by other routes. Pharmacokinetics study of 131I Armenicums in rabbits, showed that during the first hours after the intravenous infusion, the iodine is intensively accumulated in the liver, tissues of head, in chest and abdominal cavity and is eliminated uniformly within 6 days.

Indications
Armenicums is intended for treatment of HIV-infected adults in the symptomatic and AIDS stages, especially at initial level of VL > 10000 cop/ml and CD4+ T-cells count < 500/mm3. Controlled studies on its efficacy of combined therapy with antiretroviral drugs have not been carried out.

Dosage and administration
It is necessary to shake the vial well before preparing the solution for infusion. The drug is infused after extempore dilution with 0.9% solution of sodium chloride in a 1: 4 ratio and more (usually in 500ml). Recommended dose of Armenicums monotherapy is 0.2-0.3 ml/kg of body weight.

Mode of administration
The drug is administered intravenously, dropwise, at a speed of 4-9ml/min. In case of burning along the punctured vein it is recommended to slow down the rate of infusion. Infusion of ARM in the small veins is not recommended.

Treatment duration
The treatment course of the monotherapy with Armenicum consists of 4 treatment cycles performed with 3 weeks interval. Each treatment cycle includes 3 infusions administered every other day, i.e. 12 infusions are administered during one treatment course. Hospital observation of the patients is not required during the intervals between the treatment cycles.

Side-effects
The clinical trials have shown that the monotherapy with Armenicums is well tolerated. The drug side-effects include phlebitis at the site of the punctured vein, transient fever, chills, headache, weakness, malaise and sweating. Side-effects do not require withdrawal of treatment. In case of burning along the punctured vein it is recommended to slow down the rate of infusion. At the end of infusion it is preferable to put a bandage with heparin ointment for some hours.

Contraindications
Armenicums should not be used in patients with hypersensitivity to any of its ingredients.

Precautions
It is not recommended to inject into small veins.

Pregnancy
Controlled studies in pregnant women have not been carried out.

Breast-feeding
It is unknown whether Armenicums is excreted with breast milk. However, as the majority of drugs are excreted with the breast milk and the possibility of drug side effects in infants is not excluded, breast-feeding should be interrupted during the treatment with Armenicums.

Use in children
No data on safety and efficacy of Armenicums in children are available.

Overdosage
Unknown. (Maximal tolerated dose by the laboratory animals at multiple administration of the drug is 0.8-2.0ml/kg ).

Interaction with other medications
Studies of Armenicum interaction with other medications have not been carried out.

Administration peculiarities
The first signs of health improvement are observed within 1-2 weeks. The treatment with Armenicums does not imply an obligatory use of antiretroviral drugs. Symptomatic treatment, administration of medications for primary and secondary prophylaxis of opportunistic diseases and etiotropic treatment of concomitant diseases are permitted.

Storage conditions and shelf life
Store in a dry place at temperature no more than +22˚C. Protect from light. Do not freeze. Shelf life is 2 years.

Prescription/delivery
To be used only under hospital conditions by the physician’s prescription.

Packaging
Orange glass vials per 20ml in the cardboard package with the instructions for use.

Manufacturer
CJSC“Armenicums+”



Address
p/o/box 6007 reshon lezyon/ israel

Tel ++972524878166

Fax++ 97239518174

E .Mail alex@levin.name























Clinical Center

Armenicums” ClinicalCenter is a free-standing, multi-specialty investigative research facility dedicated to conducting clinical research trials efficiently and at the highest level of quality. Our primary objectives are to provide optimal patient care and peerless service, maximizing our clients' productivity by meeting enrollment goals and providing error-free research study reports. We aim to develop and maintain long-term relationships with our clients and establish “Armenicums” ClinicalCenter as a premier clinical research center.

“Armenicums” ClinicalCenter has been founded in December 1999. Situated in the South-Western part of the Yerevan, capital of Armenia, “Armenicums” ClinicalCenter is less than a half hour's drive from “Zvartnots” international airport. It accomodates both the inpatient and outpatient facilities of the “Armenicum” Project. When you approach the entrance of the Center, gardens filled with seasonal flowers greet you. Within the Center, our collection of original pieces of art and posters is on display in hallways, waiting rooms and offices.

Our facility is housed in 3,000 sq. m. and includes diagnostic department, two inpatient departments, department of reanimation and intensive care, sophisticated laboratory, in-house pharmacy and secure record storage. There is also data analysis department with a state-of-the-art computer network.

The inpatient facility consists of 1- or 2-bed wards (total capacity 52 beds) geared to keeping patients as comfortable as possible. Each ward is provided with air-conditioner, refrigerator and TV set. There is a recreational area where patients can play table tennis or pool or listen CDs. Patients are allowed to receive telephone calls, and can make local and international calls from the Center.

Intensive care department consists of 10-bed infusion hall, 2-bed reanimation hall and a room for minor surgical interventions. In the infusion hall Armenicum is infused under the strict supervision of an investigator. The reanimation hall is equipped with up-to-date artificial lung ventilation apparatus, cardiomonitors, defibrillators, centralized system of oxygenotherapy and other equipment necessary for intensive and emergency care.

Laboratory department includes laboratories of clinical chemistry, microbiology, immunology, serology, molecular biology, and virology. Sophisticated and up-to-date equipment makes possible the full-range high quality tests including CD4 cell counts with flow cytometry and viral load measurements with PCR.



Multi-lingual research staff of “Armenicums” ClinicalCenter includes 5 investigators and 14 co-investigators which are all qualified health professionals, some of them having MD, PhD and MPH degrees. The Principal Investigator is Levon M. Mkhitaryan, M.D., who is responsible for overall conduct and coordination of the clinical research program. Clinical staff members are trained in blood pressure monitoring, CPR, emergency medicine technology, advanced cardiac life support, ECG, and phlebotomy. Besides the physicians and nurses, the “Armenicums” ClinicalCenter staff includes many others, such as laboratory technologists, pharmacists, support and administrative staff. “Armenicums” ClinicalCenter also has staff members who are dedicated to patient recruitment, utilizing multi-media advertising, extensive databases, specialized community events, and public health education opportunities to ensure top study enrollments.

“Armenicums” ClinicalCenter is the first hospital in Armenia where Good Clinical Practice (GCP) is established. Regular on-site training on GCP for investigators and staff and strict adherence to GCP standards ensure the highest quality of clinical research and determine “Armenicums” Clinical Center as striving to become the Center of Excellence for clinical trials in Transcaucasian region.

Our greatest preoccupation is quality. At “Armenicums” ClinicalCenter this philosophy is practiced at every level from management of regulatory documents to patient care. Our dedicated investigators and staff constantly strive to make the clinical trials program successful for both the patient and the sponsor. Our experienced staff carefully screens patients to ensure they are a good fit for the study. Strict adherence to protocol and GCP and careful record keeping minimize queries. Extensive clinical experience ensures the highest quality of patient care.

The “Armenicums” ClinicalCenter team is sensitive to the privacy concerns of participants. Every effort is made to insure that records are protected. In all study records a numerical code (patient identifier or "PID") is assigned to each participant. Actual names do not appear on the study records. The patient roster, which connects names to the PIDs, is kept in a locked cabinet. We respect the rights of all our patients, without regard to gender, sexual orientation, social, cultural, educational or religious background.

We are available to help physicians and other health care professionals from outside Armenia who wish to refer patients, consult with our specialists or obtain information on “Armenicums” Project. We are also committed to providing potential patients with prompt responses to their requests for information on participation in “Armenicums” clinical research program. Patients wishing to participate in “Armenicums” clinical research should complete the Online Patient Participation Form (see Patient Information), or call or fax us.

אתה בכלל קראת מה כתוב שם . או בכלל הבנת מה כתוב שם.

צר עולמך כעולם הנמלה.

,שאין עליה שום מידע נוסף למעט את אותה הודעה בדיוק שאתה בעצמך פירסמת באתרים נוספים וששותפך המסתורי לתרופת פלא זה הוא "דוקטור של כבוד" באקדמיה הארמנית למדע ואתה מצפה מאיתנו לבלוע את הלוקש הזה?

תמשיך לפרסם תמונות של בחורות במה שבראש.

ציטוט:

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