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 2001, 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 first of January 2004, 251 cases of HIV-infection were registered. 51 females and 3 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.
By sponsorship of Mr. Levon Gevorgyan, Honorary Doctor of NAS of the RA, Head of “Armenicum” project, a creative scientific-research group at the head of academician Emil S. Gabrielyan, the scientific supervisor of “Armenicum” 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 “Armenicum” 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 “Armenicum” 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 “Armenicum”, 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:
- Armenicum 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.
- It decreases HIV-1 viral load.
- It improves the immune status, evaluated by changes in T4-lymphocytes count and integral surrogate markers.
- 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.
- 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.
- The drug “Armenicum” does not cause resistance in human organism which is one of its main properties.
The new clinic of Armenicum 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 “Armenicum” 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 “Armenicum” 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 “Armenicum” are being conducted in some countries of the world, such as Russia, Ukraine, India as well as in some countries of African continent, particularly in Democratic Republic of Congo, Zambia, Liberia. At present the clinical trials are completed and the drug is in the process of registration.
Application for registration of the drug “Armenicum” has been presented in the following countries: Russia, Ukraine, Greece, Democratic Republic of Congo, Liberia, Zambia, Zimbabwe, South African Republic, India and others.
In order to register and invest Armenicum in pharmaceutical markets clinical trials of Armenicum are being conducted in different countries
Armenicum was registered in Democratic Republic of Congo, Liberia and India.
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.
Revision date: June 20, 2011
Last revised: by Janet A. Staessen, MD, PhD