AU2004206996A1

AU2004206996A1 - A therapeutic composition for the treatment of HIV-1 and HIV-2

Info

Publication number: AU2004206996A1
Application number: AU2004206996A
Authority: AU
Inventors: Jelen Boguslaw
Original assignee: EXCYTON-EXCYMER GmbH
Current assignee: EXCYTON-EXCYMER GmbH
Priority date: 2003-01-29
Filing date: 2004-01-29
Publication date: 2004-08-12
Also published as: RU2005123957A; WO2004066954A3; KR20050094461A; CA2514252A1; CN1747726A; ZA200505977B; EP1589961A2; WO2004066954A2; JP2006516633A; EP1589961A4

Description

WO 2004/066954 PCT/US2004/002536 A THERAPEUTIC COMPOSITION FOR THE TREATMENT OF HIV-1 AND HIV-2 s Applicant claims the benefit of following prior filed co-pending U.S. Patent Application, Serial No. 10/353,483, filed 29 January 2003. BACKGROUND OF THE INVENTION A pharmaceutical mixture for blocking the HIV-1 and/or HIV-2 virus 10 replication in the CD4+ cells of the human immune system in all stages of that viral infection, and in AIDS, also the method of production of the pharmaceutical mixture for blocking the HIV-1 and HIV-2 virus replication in the CD4+ cells of the human immune system in all stages of that viral infection, and in AIDS. Hereinafter it should be understood that the terms "HIV treatment" and is "treatment of HIV in a patient in need of such treatment" mean treating a patient with HIV-1 and/or HIV-2. Additionally, the term "blocking IV virus replication" means blocking HIV- 1 and/or HIV-2 virus replication. Further the term "HIV virus" refers to the HIV- 1 and/or HIV-2 virus. Still further, the term "HIV infection" refers to HIV- 1 and/or HIV-2 infection. 20 The subject of the invention is a pharmaceutical mixture for blocking the HIV-1 and HIV-2 virus replication in the CD4+ cells of the human inmmune system in all stages of that viral infection, and in AIDS, also the method of production of the pharmaceutical mixture for blocking the HIV- I and HIV-2 virus replication in the CD4+ cells of the human immune system in all stages of that viral infection, 25 and in AIDS.

WO 2004/066954 PCT/US2004/002536 -2 The invented mixture has a particular application in treatment of the Acquired Immunodeficiency Syndrome, or AIDS. Synopsis of the Description The subject of the invention is a pharmaceutical mixture for blocking the 5 HIV-1 and HIV-2 virus replication in the CD4+ cells of the human immune system in that viral infection, and in AIDS contains previously known carriers and/or auxiliary substances, as well as active substances, and it is characterized by the presence of at least 10 chemical substances as active substances, among them, allocryptopine, present in the amount from 1.0 mg to 10.0 mg; nimodipine, present 10 in the amount from 20.0 mg to 100.0 mg; potassium iodide, present in the amount from 120.0 mg to 560.0 mg; potassium iodate, present in the amount from 30.0 mg to 140.0 mg; inulina, present in the amount from 125.0 mg to 375.0 mg; silver, present in the amount from 0.10 mg to 0.50 mg; zinc, present in the amount from 10.0 mg to 20.0 mg; chromium, present in the amount from 0.05 mg to 0.20 mg; is orotic acid, present in the amount from 150.0 mg to 500.0 mg; desferrin, present in the amount from 100.0 mg to 300.0 mg Summary A pharmaceutical mixture and a method of its production of a therapeutic 20 composition for blocking the HIV-1 and HIV-2 virus replication in the CD4+ cells of the human immune system in all stages of that viral infection, and in AIDS for the treatment of HIV in a patient in need of such treatment, the therapeutic composition comprising of pharmaceutically effective amounts of allocryptopine, WO 2004/066954 PCT/US2004/002536 -3 nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid and desferrin. In one embodiment of the invention, the pharmaceutical mixture and method further comprises pharmaceutically effective amounts of taraxasterol and B-sitosterol. 5 Detailed Description of the Invention The invention pertains also to the method of production of the pharmaceutical mixture for blocking the HIV- 1 and HIV-2 virus replication in the CD4+ cells of the human immune system in all stages of that viral infection, and in 10 AIDS, characterized by mixing, in the room temperature, of allocryptopine, in the amount from 1.0 mg to 10.0 mg; nimodipine, in the amount from 20.0 mg to 100.0 mg; potassium iodide, in the amount from 120.0 mg to 560.0 mg; potassium iodate, in the amount from 30.0 mg to 140.0 mg; inuline, in the amount from 125.0 mg to 375.0 mg; silver, in the amount from 0.10 mg to 0.50 mg; zinc, in the amount from 15 10.0 mg to 20.0 mg; chromium, in the amount from 0.05 mg to 0.20 mg; orotic acid, in the amount from 150.0 mg to 500.0 mg; desferrin, in the amount from 100.0 mg to 300.0 mg, until a mix approximating uniform substance is produced, subsequently pressed into tablets, and can also have a form of coated tablets, or can be shaped into a wafer, a suppository, effervescent powder, gel, or colloid solution; 20 or made into suspension, syrup, salt soluble in body fluids, or liquid for intramuscular or IV injections, also in ampules. In the existing publications pertaining to treatment regimens for patients with a diagnosed HTV infection, or with the Acquired Immunodeficiency Syndrome WO 2004/066954 PCT/US2004/002536 -4 (AIDS), there has been no description of any medications/ pharmaceutical preparations for blocking the HIV-1 and HIV-2 virus replication in the CD4+ cells of the human immune system based on the reasoning adopted here. The premiss underlying the invention discussed here is the reasoning that s the basis for the HIV- I and HIV-2 virus replication in the CD4+ cells of the human immune system is the exeitono-excimeric correlation between the HIV- I and HIV 2 viruses and the CD4 cell of the human immune system. The effect of the adoption of that reasoning is as follows: the initiation of the therapy aimed at treatment of the HIV-1 and HIV-2 viral infections, and AIDS, 10 is reduced to delivering substances completely blocking the mechanism causing the HIV- 1 and HIV-2 replication to the patient's body. The following substances proved to be helpful in that task: allocryptopine, an alkaloid found in the Chelidonium maius plant, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid and desferrin. Other is substances found to be helpful in this task were taraxasterol and B-sitosterol. It is known that: allocryptopine is a nucleotide phosphodiesterase blocker, nimodipine is a calcium channel blocker, potassium iodide when combined with potassium iodate in the acidic environment, produces iodic free radicals, inuline is a polysaccharide which is not decomposed in the body; silver, zinc, and chromium 20 are elements playing a role in the enzymatic processes, - desferrin chelates ferric ions, - orotic acid a the precursor of the nucleotide compounds. However, the substances listed above have never appeared nor been applied together, and in particular they have not been used together in the therapeutic WO 2004/066954 PCT/US2004/002536 -5application such as those described in this invention. The goal of the invention is supplying the pharmaceutical mixture for blocking the HIV-1 and IV-2 virus replication in the CD4+ cells of the human immune system. 5 The invention provides that the pharmaceutical mixture for blocking the HIV-1 and HIV2 virus replication in the CD4+ cells of the human immune system in all stages of that viral infection, and in AIDS, contains previously known carriers and/or auxiliary substances, as well as active substances, and it is characterized by the presence of at least 10 chemical substances as active substances, among them: 10 - allocryptopine is present in the amount from 1.0 mg to 10.0 mg, - nimodipine is present in the amount from 20.0 mg to 100.0 mg, - potassium iodide is present in the amount from 120.0 mg to 560.0 mg, - potassium iodate is present in the amount from 30.0 mg to 140.0 mg, - inuline is present in the amount from 125.0 mg to 375.0 mg, 15 - silver is present in the amount from 0.10 mg to 0.50 mg, - zinc is present in the amount from 10.0 mg to 20.0 mg, - chromium is present in the amount from 0.05 mg to 0.20 mg, - orotic acid is present in the amount from 150.0 mg to 500.0 mg, -desferrin is present in the amount from 100.0 mg to 300.0 mg 20 It is beneficial when: - allocryptopine content is 10.0 mg, WO 2004/066954 PCT/US2004/002536 -6 - and nimodipine content is 100.0 mg, - and potassium iodide content is 560.0 mg, - and potassium iodate content is 140.0 mg, - and inuline content is 375.0 ing, - and silver content is 0.50 mg, - and zinc content is 20.0 mg, - and chromium content is 0.20 mg, - and orotic acid content is 500.0 mg, - and desferrin content is 300.0 mg. 10 It is beneficial when: - allocryptopine content is 4.50 mg, - and nimodipine content is 60.0 mg, - and potassium iodide content is 340.0 mg, is - and potassium iodate content is 85.0 mg, - and inuline content is 250.0 mg, - and silver content is 0.30 mg, - and zinc content is 15.0 mg, - and chromium content is 0.125 mg, 20 - and orotic acid content is 325.0 mg, - and desferrin content is 200.0 mg. It is beneficial when: WO 2004/066954 PCT/US2004/002536 -7 - allocryptopine content is 4.50 mg, - and nimodipine content is 60.0 mg, - and potassium iodide content is 340.0 mg, - and potassium iodate content is 85.0 mg, 5 - and inuline content is 250.0 mg, - and silver content is 0.30 mg, - and zinc content is 15.0 mg, - and chromium content is 0.125 mg, - and orotic acid content is 325.0 mg, 1o - and desferrin content is 200.0 mg, - and taraxasterol content is 350 mg, - and B-sitosterol content is 400 mg, It is beneficial when: 15 - allocryptopine content is 1.0 mg, - and nimodipine content is 20.0 mg, - and potassium iodide content is 120.0 mg, - and potassium iodate content is 30.0 mg, - and inuline content is 125.0 mg, 20 - and silver content is 0.10 mg, - and zinc content is 10.0 mg, - and chromium content is 0.05 mg, - and orotic acid content is 250.0 mg, WO 2004/066954 PCT/US2004/002536 - and desferrin content is 100.0 mg, - and taraxasterol content is 250 mg, - and B-sitosterol content is 300 mg s It is beneficial when: - allocryptopine content is 1.0 mg, - and nimodipine content is 20.0 mg, - and potassium iodide content is 120.0 mg, - and potassium iodate content is 30.0 mg, 10 - and muline content is 125.0 mg, - and silver content is 0.10 mg, - and zinc content is 10.0 mg, - and chromium content is 0.05 mg, - and orotic acid content is 250.0 mg, is - and desferrin content is 100.0 mg. It is beneficial when the weight ratio of allocryptopine to nimodipine to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to orotic acid to desferrin is generally maintained as 1:20:120:30:125:0.1:10:0.05:250:100. 20 It is beneficial when the mixture of the ingredients has a form of a tablet, or coated tablet, or wafer, or suppository, or effervescent powder, or gel, or colloid solution. It is beneficial when the mixture of the ingredients has a form of WO 2004/066954 PCT/US2004/002536 -9 suspension, or syrup, or salt soluble in body fluids, or liquids for intramuscular or IV injections. The production of the pharmaceutical mixture for blocking the HIV-1 and HIV-2 virus replication in the CD4+ cells of the human immune system in all 5 stages of that viral infection, and in AIDS, is characterized by mixing, in the room temperature, the following ingredients: - - allocryptopine in the amount from 1.0 mg to 10.0 mg, - nimodipme in the amount from 20.0 mg to 100.0 mg, - potassium iodide in the amount from 120.0 mg to 560.0 mg, 10 - potassium iodate in the amount from 30.0 mg to 140.0 mg, - inline in the amount from 125.0 mg to 375.0 mg, - silver in the amount from 0.10 ing to 0.50 mg, - zinc in the amount from 10.0 mg to 20.0 mg, - chromium in the amount from 0.05 mg to 0.20 mg, 15 - orotic acid in the amount from 150.0 mg to 500.0 mg, -desferrin in the amount from 100.0 mg to 300.0 mg, until homogeneous mixture is created. It is beneficial when: 20 - allocryptopine content is 10.0 mg, - and nimodipine content is 100.0 mg, - and potassium iodide content is 560.0 mg, - and potassium iodate content is 140.0 mg, WO 2004/066954 PCT/US2004/002536 -10 - and inuline content is 375.0 mg, - and silver content is 0.50 mg, - and zinc content is 20.0 mg, - and chromium content is 0.20 mg, 5 - and orotic acid content is 500.0 mg, - and desferrin content is 300.0 mg. It is beneficial when: - allocryptopine content is 4.50 mg, - and nimodipine content is 60.0 mg, 1o - and potassium iodide content is 340.0 mg, - and potassium iodate content is 85.0 mg, - and inuline content is 250.0 mg, - and silver content is 0.30 mg, - and zinc content is 15.0 mg, 15 - and chromium content is 0.125 mg, - and orotic acid content is 325.0 mg, - and desferrin content is 200.0 mg. It is beneficial when: - allocryptopine content is 1.0 mg, 20 - and nimodipine content is 20.0 mg, - and potassium iodide content is 120.0 mg, - and potassium iodate content is 30.0 mg, - and inuline content is 125.0 mg, WO 2004/066954 PCT/US2004/002536 -11 - and silver content is 0.10 mg, - and zinc content is 10.0 mg, - and chromium content is 0.05 mg, - and orotic acid content is 250.0 mg, 5 - and desferrin content is 100.0 mg. It is beneficial when the weight ratio of allocryptopine to nimodipme to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to orotic acid to desferrin is generally maintain as 1:20:120:30:125:0.1:10:0.05:250:100. 10 The pharmaceutical mixture and method of making it may further comprise pharmaceutically effective amounts of taraxasterol and B-sitosterol. It is beneficial when the pharmaceutical mixture and method of making it is characterized by mixing, in the room temperature, of allocryptopine, in the amount from 1.0 mg to 10.0 mg; nimodipine, in the amount from 20.0 mg to 100.0 mg; potassium iodide, 15 in the amount from 120.0 mg to 560.0 mg; potassium iodate, in the amount from 30.0 mg to 140.0 mg; inuline, in the amount from 125.0 mg to 375.0 mg; silver, in the amount from 0.10 mg to 0.50 mg; zinc, in the amount from 10.0 mg to 20.0 mg; chromium, in the amount from 0.05 mg to 0.20 mg; orotic acid, in the amount from 150.0 mg to 500.0 mg; desferrin, in the amount from 100.0 mg to 300.0 mg; 20 taraxasterol, in the amount from 250-400 mg, and B-sitosterol in the amount from 300-500 mg until a mix approximating uniform substance is produced, subsequently pressed into tablets, and can also have a form of coated tablets, or can be shaped into a wafer, a suppository, effervescent powder, gel, or colloid solution; WO 2004/066954 PCT/US2004/002536 -12 or made into suspension, syrup, salt soluble in body fluids, or liquid for intramuscular or IV injections, also in ampules. It is beneficial when the weight ratio of allocryptopine to nimodipine to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to s orotic acid to desferrin to taraxasterol to B-sitosterol is generally maintain as 1:20:120:30:125:0.1:10:0.05:250:100:400:500. It is also beneficial when the weight ratio of allocryptopine to nimodipine to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to orotic acid to desferrin to taraxasterol to B-sitosterol is generally maintain as 10 1:20:120:30:125:0.1:10:0.05:250:100:350:400. It is beneficial when the mixture of the ingredients has a form of a tablet, or coated tablet, or wafer, or suppository, or effervescent powder, or gel, or a colloid solution. It is beneficial when the mixture of the ingredients has a form of 15 suspension, or syrup, or salt soluble in body fluids, or liquids for intramuscular or IV injections. The beneficial effect of the pharmaceutical mixture in the invention is blocking the mechanism of attaching the gp 160 protein of the HIV virus capsule to the receptors of the CD4+ cells of the human immune system, as well as blocking 20 the intracellular processes related to the HIV-1 and HIV-2 virus replication. Example No. 1. Content of the pharmaceutical mixture: - allocryptopine in the amount of 10.0 mg, WO 2004/066954 PCT/US2004/002536 -13 - nimodipine in the amount of 100.0 mg, - potassium iodide in the amount of 560.0 mg, - potassium iodate in the amount of 140.0 mg, - inuline in the amount of 375.0 mg, s - silver in the amount of 0.50 mg, - zinc in the amount of 20.0 mg, - chromium in the amount of 0.20 mg, - orotic acid in the amount of 500.0 mg, - desferrin in the amount of 300.0 mg. 10 Production of the pharmaceutical mixture: Mix together in the room temperature: 10.0 mg of allocryptopine, 100.0 mg of nimodipine, 560.0 mg of potassium iodide, 140.0 mg of potassium iodate, 375.0 mg of inuline, 0.50 mg of silver, 20.0 mg of zinc, 0.20 mg of chromium, 500.0 mg of orotic acid, and 300.0 mg of desferrin. is After adding all ingredients, mix them all together for about 10-20 minutes until a uniform substance is produced. The mix can then be pressed into tablets, and can also have a form of coated tablets, or can be shaped into a wafer, a suppository, effervescent powder, gel, or colloid solution. 20 Example No. 2. Content of the pharmaceutical mixture: - allocryptopine in the amount of 1 .0 mg, - nimodipine in the amount of 20.0 mg, - potassium iodide in the amount of 120.0 mg, WO 2004/066954 PCT/US2004/002536 -14 - potassium iodate in the amount of 30.0 mg, - mulme in the amount of 125.0 mg, - silver in the amount of 0.10 mg, - zinc in the amount of 10.0 mg, S - chromium in the amount of 0.05 mg, - orotic acid in the amount of 150.0 mg, - desferrin in the amount of 100.0 mg. Production of the pharmaceutical mixture: Mix together in the room temperature: 1.0 mg of allocryptopine, 20.0 mg of 10 nimodipine, 120.0 mg of potassium iodide, 30.0 mg of potassium iodate, 125.0 mg of inuline, 0.10 mg of silver, 10.0 mg of zinc, 0.05 mg of chromium, 150.0 mg of orotic acid, and 100.0 mg of desferrin. After adding all ingredients, mix them all together for about 10-20 minutes until a uniform substance is produced. 15 The product can then be made into suspension, syrup, salt soluble in body fluids, or liquid for intramuscular or IV injections, also in ampules. Example No. 3. Content of the pharmaceutical mixture: - allocryptopine in the amount of 10.0 mg, 20 - nimodipine in the amount of 100.0 mg, - potassium iodide in the amount of 560.0 mg, - potassium iodate in the amount of 140.0 mg, - inuline in the amount of 375.0 mg, WO 2004/066954 PCT/US2004/002536 -15 - silver in the amount of 0.50 mg, - zinc in the amount of 20.0 mg, - chromium in the amount of 0.20 mg, - orotic acid in the amount of 500.0 mg, 5 - desferrin in the amount of 300.0 mg, - taraxasterol in the amount of 400 mg, - B-sitosterol in the amount of 500 mg. Production of the pharmaceutical mixture: Mix together in the room temperature: 10.0 mg of allocryptopine, 100.0 mg 10 of nimodipine, 560.0 mg of potassium iodide, 140.0 mg of potassium iodate, 375.0 mg of inuline, 0.50 mg of silver, 20.0 mg of zinc, 0.20 mg of chromium, 500.0 mg of orotic acid, 300.0 mg of desferrin, 400 mg of taraxasterol, and 500mg. of B sitosterol. After adding all ingredients, mix them all together for about 10-20 minutes 15 until a uniform substance is produced. The mix can then be pressed into tablets, and can also have a form of coated tablets, or can be shaped into a wafer, a suppository, effervescent powder, gel, or colloid solution. Example No. 4. Content of the pharmaceutical mixture: 20 - allocryptopine in the amount of 1.0 mg, - nimodipine in the amount of 20.0 mg, - potassium iodide in the amount of 120.0 mg, - potassium iodate in the amount of 30.0 mg, WO 2004/066954 PCT/US2004/002536 -16 - mulme in the amount of 125.0 mg, - silver in the amount of 0.10 mg, - zinc in the amount of 10.0 mg, - chromium in the amount of 0.05 mg, 5 - orotic acid in the amount of 150.0 mg, - desferrin in the amount of 100.0 mg, - taraxasterol in the amount of 250 mg, - B-sitosterol in the amount of 300 mg. 10 Production of the pharmaceutical mixture: Mix together in the room temperature: 1.0 mg of allocryptopine, 20.0 mg of nimodipine, 120.0 mg of potassium iodide, 30.0 mg of potassium iodate, 125.0 mg of inuline, 0.10 mg of silver, 10.0 mg of zinc, 0.05 mg of chromium, 150.0 mg of orotic acid, 100.0 mg of desferrin, 250 mg of taraxasterol, and 300mg. of B 15 sitosterol. After adding all ingredients, mix them all together for about 10-20 minutes until a uniform substance is produced. The product can then be made into suspension, syrup, salt soluble in body fluids, or liquid for intramuscular or IV injections, also in ampules. 20 It should be understood that the term "pharmaceutically effective amount" means an effective amount of the pharmaceutical mixture of the present invention (comprising a mixture of allocryptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid and desferrin). Actual dosage WO 2004/066954 PCT/US2004/002536 -17 levels of the pharmaceutical composition of this invention can be varied so as to achieve the desired therapeutic response for a particular patient, compositions and mode of administration. The selected dosage level will depend upon the activity of the particular compound, the route of administration, the severity of the condition 5 being treated and the condition and prior medical history of the patient being treated. However, it is within the skill of the art to start doses of the compound at levels lower than required to achieve the desired therapeutic effect and to gradually increase the dosage until the desired effect is achieved.

Claims

1. A therapeutic composition for the treatment of HIV in a patient in need of such treatment, the therapeutic composition comprising of 5 pharmaceutically effective amounts of allocryptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid and desferrin.

2. The therapeutic composition of claim 1, wherein the allocryptopine is present in the amount from about 1.0 mg to about 10.0 mg, nimodipine is present io in the amount from about 20.0 mg to about 100.0 mg, potassium iodide is present in the amount from about 120.0 mg to about 560.0 mg, potassium iodate is present in the amount from about 30.0 mg to about 140.0 mg, inuline is present in the amount from about 125.0 mg to about 375.0 mg, silver is present in the amount from about 0.10 mg to about 0.50 mg, zinc, present in the amount from 10.0 mg to is about 20.0 mg, chromium is present in the amount from about 0.05 mg to about 0.20 mg, orotic acid is present in the amount from about 150.0 mg to about 500.0 mg, and the desferrin is present in the amount from about 100.0 mg to about 300.0 mg. 20 3. The therapeutic composition of claim 1, wherein the allocryptopine is present in the amount of about 10.0 mg, the nimodipine is present in the amount of about 100.0 mg, the potassium iodide is present in the amount of about 560.0 mg, the potassium iodate is present in the amount of about 140.0 mg, the inuline is WO 2004/066954 PCT/US2004/002536 -19 present in the amount of about 375.0 mg, the silver is present in the amount of about 0.50 mg, the zinc is present in the amount of about 20.0 mg, the chromium is present in the amount of about 0.20 mg, the orotic acid is present in the amount of about 500.0 mg, and the desferrin is present in the amount of about 300.0 mg. 5

4. The therapeutic composition of claim 1, wherein the allocryptopine is present in the amount of about 4.5 mg, the nimodipine is present in the amount of about 60.0 mg, the potassium iodide is present in the amount of about 340.0 mg, the potassium iodate is present in the amount of about 85.0 mg, the inuline is 10 present in the amount of about 250.0 mg, the silver is present in the amount of about 0.30 mg, the zinc is present in the amount of about 15.0 mg, the chromium is present in the amount of about 0.125 mg, the orotic acid is present in the amount of about 325.0 mg, and the desferrin is present in the amount of about 200.0 mg. is 5. The therapeutic composition of claim 1, wherein the allocryptopine is present in the amount of about 1.0 mg, the nimodipine is present in the amount of about 20.0 mg, the potassium iodide is present in the amount of about 120.0 mg, the potassium iodate is present in the amount of about 30.0 mg, the inuline is present in the amount of about 125.0 mg, the silver is present in the amount of 20 about 0.10 mg, the zinc is present in the amount of about 10.0 mg, the chromium is present in the amount of about 0.05 mg, the orotic acid is present in the amount of about 250.0 mg, and the desferrin is present in the amount of about 100.0 mg. WO 2004/066954 PCT/US2004/002536 -20

6. The therapeutic composition of claim 1 further comprises a weight ratio of allocryptopine to nimodipine to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to orotic acid to desferrin of about 1:20:120:30:125:0.1:10:0.05:250:100, respectively. 5

7. The therapeutic composition of claim 1, wherein said composition is in a form suitable for administering to a patient, wherein the form is selected from the group consisting of a tablet, coated tablet, wafer, suppository, effervescent powder, gel, and a colloid suspension. 10

8. A therapeutic composition for the treatment of HIV in a patient in need of such treatment, the therapeutic composition comprising of pharmaceutically effective amounts of allocryptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid, desferrin, is taraxasterol and B-sitosterol.

9. The therapeutic composition of claim 8, wherein the allocryptopine is present in the amount from about 1.0 mg to about 10.0 mg, nimodipine is present in the amount from about 20.0 mg to about 100.0 mg, potassium iodide is present 20 in the amount from about 120.0 mg to about 560.0 mg, potassium iodate is present in the amount from about 30.0 mg to about 140.0 mg, inuline is present in the amount from about 125.0 mg to about 375.0 mg, silver is present in the amount from about 0.10 mg to about 0.50 mg, zinc, present in the amount from 10.0 mg to WO 2004/066954 PCT/US2004/002536 -21 about 20.0 mg, chromium is present in the amount from about 0.05 mg to about 0.20 mg, orotic acid is present in the amount from about 150.0 mg to about 500.0 mg, the desferrin is present in the amount from about 100.0 mg to about 300.0 mg, the taraxasterol is present in the amount from about 250mg to about 400 mg, and 5 the B-sitosterol is present in the amount from about 300 mg to about 500 mg.

10. The therapeutic composition of claim 8, wherein the allocryptopine is present in the amount of about 10.0 mg, the nimodipine is present in the amount of about 100.0 mg, the potassium iodide is present in the amount of about 560.0 10 mg, the potassium iodate is present in the amount of about 140.0 mg, the inuline is present in the amount of about 375.0 mg, the silver is present in the amount of about 0.50 mg, the zinc is present in the amount of about 20.0 mg, the chromium is present in the amount of about 0.20 mg, the orotic acid is present in the amount of about 500.0 mg, the desferrin is present in the amount of about 300.0 mg, the 15 taraxasterol is present in the amount of about 400 mg, and the B-sitosterol is present in the amount of about 500 mg. '11. The therapeutic composition of claim 8, wherein the allocryptopine is present in the amount of about 4.5 mg, the nimodipine is present in the amount 20 of about 60.0 mg, the potassium iodide is present in the amount of about 340.0 mg, the potassium iodate is present in the amount of about 85.0 mg, the inuline is present in the amount of about 250.0 mg, the silver is present in the amount of about 0.30 mg, the zinc is present in the amount of about 15.0 mg, the chromium is present in the amount of about 0.125 mg, the orotic acid is present in the amount of WO 2004/066954 PCT/US2004/002536 -22 about 325.0 mg, the desferrin is present in the amount of about 200.0 mg, the taraxasterol is present in the amount of about 350 mg, and the B-sitosterol is present in the amount of about 400 mg. S 12. The therapeutic composition of claim 8, wherein the allocryptopine is present in the amount of about 1.0 mg, the nimodipine is present in the amount of about 20.0 mg, the potassium iodide is present in the amount of about 120.0 mg, the potassium iodate is present in the amount of about 30.0 mg, the inuline is present in the amount of about 125.0 mg, the silver is present in the amount of io about 0.10 mg, the zinc is present in the amount of about 10.0 mg, the chromium is present in the amount of about 0.05 mg, the orotic acid is present in the amount of about 250.0 mg, the desferrin is present in the amount of about 100.0 mg, the taraxasterol is present in the amount of about 250 mg, and the B-sitosterol is present in the amount of about 300 mg. is

13. A method of preparing a pharmaceutical mixture for blocking HIV virus replication, comprising the step of mixing together pharmaceutically effective amounts of allocryptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid, and desferrin to provide the 20 pharmaceutical mixture for blocking HIV- 1 and HIV-2 virus replication.

14. The method of claim 13, wherein the step of mixing is performed at room temperature. WO 2004/066954 PCT/US2004/002536 -23

15. The method of claim 13, wherein the allocryptopine is present in the amount from about 1.0 mg to about 10.0 mg, nimodipine is present in the amount from about 20.0 mg to about 100.0 mg, potassium iodide is present in the amount from about 120.0 mg to about 560.0 mg, potassium iodate is present in the amount s from about 30.0 mg to about 140.0 mg, inuline is present in the amount from about

125.0 mg to about 375.0 mg, silver is present in the amount from about 0.10 mg to about 0.50 mg, zinc, present in the amount from 10.0 mg to about 20.0 mg, chromium is present in the amount from about 0.05 mg to about 0.20 mg, orotic acid is present in the amount from about 150.0 mg to about 500.0 mg, and the 10 desferrin is present in the amount from about 100.0 mg to about 300.0 mg. 16. The method of claim 13, wherein the allocryptopine is present in the amount of about 10.0 mg, the nimodipine is present in the amount of about 100.0 mg, the potassium iodide is present in the amount of about 560.0 mg, the is potassium iodate is present in the amount of about 140.0 mg, the inuline is present in the amount of about 375.0 mg, the silver is present in the amount of about 0.50 mg, the zinc is present in the amount of about 20.0 mg, the chromium is present in the amount of about 0.20 mg, the orotic acid is present in the amount of about

500.0 mg, and the desferrin is present in the amount of about 300.0 mg. 20 17. The method of claim 13, wherein the allocryptopine is present in the amount of about 4.5 mg, the nimodipine is present in the amount of about 60.0 mg, the potassium iodide is present in the amount of about 340.0 mg, the potassium WO 2004/066954 PCT/US2004/002536 -24 iodate is present in the amount of about 85.0 mg, the inuline is present in the amount of about 250.0 mg, the silver is present in the amount of about 0.30 mg, the zinc is present in the amount of about 15.0 mg, the chromium is present in the amount of about 0.125 mg, the orotic acid is present in the amount of about 325.0 s mg, and the desferrin is present in the amount of about 200.0 mg. 18. The method of claim 13, wherein the allocryptopine is present in the amount of about 1.0 mg, the nimodipine is present in the amount of about 20.0 mg, the potassium iodide is present in the amount of about 120.0 mg, the potassium 1o iodate is present in the amount of about 30.0 mg, the inuline is present in the amount of about 125.0 mg, the silver is present in the amount of about 0.10 mg, the zinc is present in the amount of about 10.0 mg, the chromium is present in the amount of about 0.05 mg, the orotic acid is present in the amount of about 250.0 mg, and the desferrin is present in the amount of about 100.0 mg. 15 19. The method of claim 13, wherein the pharmaceutical mixture comprises a weight ratio of allocryptopine to nimodipine to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to orotic acid to desferrin of about 1:20:120:30:125:0.1:10:0.05:250:100, respectively. 20 20. The method of claim 13 further comprising converting the pharmaceutical mixture into a form suitable for administering to a patient, wherein the form is selected from the group consisting of a tablet, coated tablet, wafer, WO 2004/066954 PCT/US2004/002536 -25 suppository, effervescent powder, gel, and a colloid. WO 2004/066954 PCT/US2004/002536 -26 21. A method of treating a HIV infection, the method comprising administering to a patient in need of such treatment a pharmaceutical mixture comprising of pharmaceutically effective amounts of allocryptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid and s desferrin. 22. The method of claim 21, wherein the pharmaceutical mixture is administered intramuscularly. 10 23. The method of claim 21, wherein the pharmaceutical mixture is administered by intravenous injection. 24. A method of preparing a pharmaceutical mixture for blocking HIV virus replication, comprising the step of mixing together pharmaceutically effective 15 amounts of allociyptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid, desferrin, taraxasterol, and B-sitosterol to provide the pharmaceutical mixture for blocking HIV- 1 and HIV-2 virus replication. 25. The method of claim 24, wherein the step of mixing is performed at 20 room temperature. -26- WO 2004/066954 PCT/US2004/002536 -27- 26. The method of claim 24, wherein the allocryptopine is present in the amount from about 1.0 mg to about 10.0 mg, nimodipine is present in the amount from about 20.0 mg to about 100.0 mg, potassium iodide is present in the amount from about 120.0 mg to about 560.0 mg, potassium iodate is present in the amount from 5 about 30.0 mg to about 140.0 mg, inuline is present in the amount from about 125.0 mg to about 375.0 mg, silver is present in the amount from about 0.10 mg to about 0.50 mg, zinc, present in the amount from 10.0 mg to about 20.0 mg, chromium is present in the amount from about 0.05 mg to about 0.20 mg, orotic acid is present in the amount from about 150.0 mg to about 500.0 mg, the desferrin is present in the 10 amount from about 100.0 mg to about 300.0 mg, the taraxasterol is present in the amount from about 250mg to about 400 mg, and the B-sitosterol is present in the amount from about 300 mg to about 500 mg. 27. The method of claim 24, wherein the pharmaceutical mixture comprises is a weight ratio of allocryptopine to nimodipine to potassium iodide to potassium iodate to inuline to silver to zinc to chromium to orotic acid to desferrin to taraxasterol to B sitosterol of about 1:20:120:30:125:0.1:10:0.05:250:100:250:300, respectively. 28. The method of claim 24 further comprising converting the pharmaceutical mixture into a form suitable for administering to a patient, wherein the 20 form is selected from the group consisting of a tablet, coated tablet, wafer, suppository, effervescent powder, gel, and a colloid. -27- WO 2004/066954 PCT/US2004/002536 -28 29. A method of treating a HIV infection, the method comprising administering to a patient in need of such treatment a pharmaceutical mixture comprising of pharmaceutically effective amounts of allocryptopine, nimodipine, potassium iodide, potassium iodate, inuline, silver, zinc, chromium, orotic acid, 5 desferrin, taraxasterol, and B-sitosterol. 30. The method of claim 29, wherein the pharmaceutical mixture is administered intramuscularly. 10 31. The method of claim 29, wherein the pharmaceutical mixture is administered by intravenous injection. -28-