Armenicum Therapeutic indications

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.

Dose regimens.
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.

Contraindications

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).