The drug “Armenicum” is intended for treatment of HIV-infected adults in symptomatic and AIDS stages.
Clinical trials of the drug were started in Scientific Clinical Centre “Armenicum” in November, 1998 (Phase II). 240 participants were included in the trial. Double-blind not controlled study results of 173 patients were summarized. The vast majority of participants at the age of 21-40 years old (79%) were in different stages of HIV-infection. As a rule, during preliminary clinical laboratory examination 6-8 various associated/concomitant diseases (dermatitis, herpes zoster, candidiasis, bronchitis, herpes simplex, psoriasis, pneumonia, viral hepatitis type “B” and “C”, neuropathy, dysbiosis, etc. have been diagnosed in each patient. Population of AIDS patients was 27%. CT participants were distributed by HIV-infection stages in the following way: stage “A”- 21%, symptomatic stage “B”-61% and stage “C”- 18%.
The route of administration and dose regimen are based on the data of Armenicum pre-clinical study, pharmacokinetics parameters in animals, healthy volunteers and HIV-infected patients, as well as the preliminary results of Armenicum clinical trial (Phase II) carried out in Armenia. The patients received Armenicum intravenously dropwise at a speed of 4-9 ml/min at 0.1, 0.2 and 0.3 ml/kg doses of body weight after extempore dilution with saline in 1:4 ratio and more. Armenicum was administered by separate treatment courses (4 courses in whole) - three injections every other day with 3 week interval.
Dosage and mode of administration
Intravenous dropwise, at a dose of 0.3ml/kg. The drug is infused after extempore dilution with saline in a 1: 4 ratio and more (usually in 500ml). The drug is administered at a speed of 4-9ml/min. In case of burning along the punctured vein is recommended to slow down the rate of infusion. Infusion of ARM in the small veins is not recommended.
Duration of one treatment course.
A course of treatment with Armenicum includes 3 infusions with 1-day intervals i.e. lasts 5 days.
Total duration of treatment.
Treatment course with “Armenicum” drug is repeated 4 times with 3 week interval. Total duration of the treatment is 13 weeks.
ARM is to be infused at a dose of 0.3 ml/kg of body weight. Open method will be used, i.e. without patients coding.
Armenicum should not be used in patients with hypersensitivity to any of its ingredients.
Special warnings and precautions
In private cases, for instance in old patients and children, patients with heart, liver, kidney decompensated diseases, the drug wasn’t particularly investigated. However, taking into account the iodine presence in the drug composition, the investigation of thyroid gland function at an intravenous administration, didn’t reveal any abnormalities in gland function (the content of serum protein bound iodine = 40-80mkg/l, absence of clinical signs of hyper- or hypofunction of thyroid gland).
Interaction with other medications
Studies of Armenicum interaction with other medications have not been carried out.
Pregnancy and lactation
Taking into account that according to WHO data, HIV-infected mother in developing countries has 25-45% possibility to give birth to an infected child. The drug administration to the pregnant women after the first 14 weeks of pregnancy, can be considered solely after evaluation of “risk/benefit” ratio.
Breast-feeding, as it is known, increases infection risk for the child in 15 and more percents depending on nursing duration and other factors. In developing countries from 1/3 to ½ of HIV-infected infants received it through breast milk. Taking into account the possibility of the drug excretion with milk, the risk of breast-feeding of infants whose mothers receive the drug should be considered thoroughly.
Side-effects and adverse events
Several side - effects may occur at intravenous administration of the drug “Armenicum”. For instance, inflammation of the punctured vein (phlebitis) lasting for some hours or some days after the infusion, slight burning along the punctured vein during the administration, disappearing after slowing down the rate of infusion are often registered. Phlebitis frequently occurs after the drug infusion into the small veins, at that the frequency and severity of complaints didn’t depend on gender. The test drug was relatively worse- tolerated in patients with AIDS, as well as in patients of older age. Chills with subsequent increase of temperature from 37 up to 40C, frequently occurs 1.5- 4 hours after the drug infusion. More frequently the patients complains of headache, weakness and malaise. Fever lasts from 4 to 10 hours.
Overdosage and symptoms
Taking into account the main active substance - iodine, at acute experiments for definition of LD50 in laboratory animals, 20% and more of the drug out of animal blood volume was administered intravenously. No characteristic signs of poisoning by halogens, except ataxia, delay and apathy were observed at oral administration of the drug at doses exceeding therapeutic doses for 53 times in rats and for 38 times - in mice.
Pharmacodynamic effects - antiviral, including antiretroviral, antibacterial, immune-stimulating action. The drug “Armenicum” possesses a wide spectrum of bactericidal action both towards Gram-positive and Gram negative microorganisms: the majority of the microorganisms, including antibiotic resistant ones, used in the experiments are died in a dilution from 1:10 to 1:100-1:200. Experiments in vivo display the drug bactericidal action against salmonelliosis and colibacteriosis at intravenous and oral administration.
In vivo and in vitro studies of the drug antiviral activity against five kinds of viruses in mice and chicken embryos established the drug virucide action at its direct effect both on DNA- and RNA-containing viruses in a dilution of 1:20 up to 1:80. The drug inhibits reproduction of influenza, encephalomyocarditis, poliomyelitis, herpes simplex, poliovaccine viruses. Virucidal effect of the drug is established in humans with different viral diseases, animals and birds.
Revision date: June 21, 2011
Last revised: by Janet A. Staessen, MD, PhD