ANTIVIRAL COMPOSITION CONTAINING OXIDIZED INOSITOL, SODIUM SULFITE, PYROCATECHOL AND COPPER SULFATE

Abstract: This invention relates to a base material having anti-viral properties, comprising a mixture of inositol oxidized with nitric acid whose pH is increased by using sodium hydroxide to which sodium sulfite, pyrocatechol, and copper sulfate are then added after dilution with distilled water and heating. Germanium sesquioxide can then be added in varying amounts to the base material solution in preparation for patient treatment. A combination of base material/germanium sesquioxide solution and, optionally, alpha -interferon are used in a specifed clinical regimen for the treatment of individuals infected with HIV. In a preferred embodiment, this treatment is combined with the use of nutritional supplements by the infected individuals.

Description: ANTTVIRAL COMPOSITION CONTAINING OXIDIZED INOSITOL, SODIUM SULFITE, PYROCATECHOL AND COPPER SULFATE Field of the Invention This invention relates to a therapeutic composition that can be used to treat human viral infections . This invention also relates to a method of making this therapeutic composition and a protocol for the clinical treatment of viral infections, generally, and human immunodeficiency virus (HIV) infections, specifically. Background of the Invention While the AIDS epidemic appears to be slowing in North America, Latin America, Western Europe, and Asia, it continues to grow in Africa. Currently, most of the approximately 28 million people worldwide who are infected with HIV reside in developing countries with 5 almost two-thirds of these individuals residing in the sub-Saharan African countries of Zambia, Zimbabwe, Kenya, and Uganda. More women than men in these countries are now infected and almost half of the pregnant women in some cities test positively for the presence of HIV. Programs to change the behaviors in these countries that cause increased risk of infection, such as male promiscuity and low condom use, have been largely unsuccessful. As a result, the great strides made in public health in these countries have been reversed and life expectancy has dropped due to this increasing incidence of HIV infection. The fact that HIV is capable of undergoing significant mutations complicates the development of effective treatments. While HIV-1 remains the infective strain seen in most of the world, variants have recently appeared. The most significant variant to appear is HIV-2, which was isolated from AIDS patients in West Africa in 1986. Surprisingly, the proteins encoded by HIV-2 are only about 40% homologous to proteins encoded by the original HIV isolates. Dual infection with HIV-1 and HIV-2 is associated with over 63% of the AIDS cases in the Ivory Coast. AIDS patients with this dual infection generally have a life expectancy of less than one year, resulting from the effects of the infection itself and the susceptibility to opportunistic infections, Kaposi's sarcoma, malnutrition, and persistent diarrhea. A treatment which is effective in delaying, controlling, or reversing the course of AIDS in individuals having combined HIV-1 and HIV-2 infections would be very desirable. An effective treatment for individuals having combined HIV-1 and HIV-2 infections would prolong their drastically shortened life, thus allowing further treatment of the HIV infection itself and its associated conditions. An effective treatment for individuals having combined HIV-1 and HIV-2 infections could also result in the deadly dual infection epidemic being eradicated or at least confined to its present locations . A treatment which is effective in converting a clinically significant portion of patients who are positive for HIV-1 and HIV-2 to those with a negative status would be a substantial step in finding a cure for AIDS . Summary of the Invention The invention subscribed herein relates to a composition of matter having anti-viral properties that is designated VIRON. In total, VIRON comprises a mixture of chemicals combined in a specific manner that is further combined with germanium sesquioxide, and is optionally used in combination with oc-interferon. The method of making and using VIRON by combining these substances is also described. A protocol for the use of VIRON alone or in combination with nutritional supplements is disclosed as a clinical treatment for viral infections, generally, and HIV infections, specifically. By using VIRON and nutritional supplements, the inventors have discovered a new and useful HIV treatment method that statistically increased CD4+ lymphocyte levels in patients infected with HIV in Africa. Using these methods, they have developed an effective treatment for individuals infected by both HIV-1 and HIV-2, thus overcoming the difficulties seen in the prior art. These methods have the potential to lead to improved treatment of AIDS patients and a cure for this disease. Detailed Description of the Invention This invention relates to a VIRON base material comprising a mixture of inositol oxidized with nitric acid whose pH is increased by using sodium hydroxide to which sodium sulfite, pyrocatechol, and copper sulfate are then added after dilution with distilled water and heating. Germanium sesquioxide is then added in varying amounts to the VIRON base material solution in preparation for patient treatment . A combination of VIRON base material/germanium sesquioxide solution and, optionally, α-interferon are used in a specified clinical regimen for the treatment .of individuals infected with HIV. This combination is designated VIRON. In a preferred embodiment, this treatment is combined with the use of nutritional supplements by the infected individuals. The compositions of this invention as well as their method of production and use in clinical treatment are further illustrated in detail by the following examples. Example 1. Preparation of the VIRON Base Material The VIRON base material is produced by oxidizing about 1 kilogram of inositol with concentrated nitric acid. This reaction should be run to completion which is indicated by the formation of a dark brown material . At room temperature, this reaction is allowed to proceed for about two days. Alternatively, the reaction can be performed in about 15 minutes at a temperature of about 290 degrees Fahrenheit. The resulting solution is heated to about 212 degrees Fahrenheit and kept at this temperature for about one hour. While at this temperature, the pH of this solution is changed to about 4.0 by adding potassium hydroxide. After the' addition of the potassium hydroxide, the solution is allowed to return to room temperature. The resulting solution is then diluted into about 7500 miHiliters of distilled water in a stainless steel container and the diluted solution is heated to a temperature of about 212 degrees Fahrenheit. While the solution is at this temperature, about 3 pounds of sodium sulfite are added. Once the sodium sulfite has dissolved and while the solution is still hot, about 330 grams of pyrocatechol are added to the solution. Once the pyrocatechol has dissolved and while the solution is still hot, about 7 grams of copper sulfate are added to the solution and dissolved. While the solution is still hot, it is diluted up to about 4 gallons in total with distilled water and the solution is allowed to cool to room temperature. Example 2. reatment Protocol : VIRON Base Material/ Germanium Sesquioxide During the first week of treatment, about 1.5 milliliters of a solution containing about 5 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution are given to each patient under the tongue four times daily. During the second week of treatment, about 1.5 milliliters of a solution containing about 10 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution are given to each patient under the tongue four times daily. During the third week of treatment, about 1.5 milliliters of a solution containing about 12 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution are given to each patient under the tongue four times daily. During the fourth week of treatment, about 1.5 milliliters of a solution containing about 20 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution are given to each patient under the tongue four times daily. During the fifth week of treatment, about 3.0 milliliters of a solution containing about 25 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution are given to each patient under the tongue four times daily. Patients are treated with the VIRON base material/germanium sesquioxide solution for periods that alternate with those in which this treatment is not given. In a preferred embodiment, patients are treated as follows : 3 months of VIRON base material/germanium sesquioxide solution treatment, 2 months without treatment; 3 months of VIRON base material/germanium sesquioxide solution treatment, 1 month without treatment; 3 months of VIRON base material/germanium sesquioxide solution treatment, then stop the treatment. Example 3 : Treatment Protocol: Oral -Interferon In a preferred embodiment, simultaneously with the VIRON base material/germanium sesquioxide solution treatment, during the first week of treatment, 1 tablet of α- interferon at a strength of 200 International Units (IU) is given orally to each patient five times daily for the first week. In a preferred embodiment, the α-interferon tablets used are Alferon. In another preferred embodiment, liquid -interferon, which is manufactured by Interferon Sciences and marketed by Purdue Frederick, is used. During the second week, 1 tablet of α-interferon at a strength of 200 IU is given orally to each patient four times daily. During the third week and thereafter until the above step of giving about 3.0 milligrams of a solution containing about 25 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to each patient four times daily is reached, 1 tablet of α-interferon at a strength of 200 IU is given orally to each patient three times daily. Once the above step of giving about 3.0 milliliters of a solution containing about 25 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to each patient four times daily is reached, then 1 tablet of α-interferon at a strength of 200 IU is given orally to each patient three times daily. From this point onward in the treatment regimen, 1 tablet of α-interferon at a strength of 200 I.U. is given orally to each patient three times daily, including during the 2-month and 1-month intervals when the VIRON base material/germanium sesquioxide solution treatment is not given. _ _ Example 4. Treatment Protocol: Nutritional Supplements In a preferred embodiment, nutritional supplements supplied by Reliv, Inc. of Chesterfield, Missouri, are given during the entire treatment regimen. Patients use the Reliv Classic nutritional supplement first. This supplement contains a mixture of proteins, herbs, and other nutritional supplements, including β-carotene, that is manufactured by Reliv, Inc. under a license from _he owner of U.S. Patent No. 4,737,364. The patients add 1 scoop of this supplement from a container to one-half liter of water and drink 3 one-half liters of this mixture per day. Due to the lack of availability of safe drinking water in sub- Saharan Africa, patients residing in this geographical area are instructed to use bottled water or boiled water. If they use the latter, they are instructed to allow it to cool before mixing in this supplement. They are also instructed to store the mixture in a cool place. One container of this nutritional supplement lasts between two and three weeks . Once patients have used up their first container of Reliv Classic, they then use the first container of the Reliv Innergize nutritional supplement. This supplement contains a mixture of vitamins and minerals. This nutritional supplement is the subject of a pending patent application. As above, the patients add 1 scoop of supplement from a container to one-half liter of water and drink 3 one-half liters of this mixture per day. Again, if they reside in sub-Saharan Africa, they are instructed to use bottled water or boiled water. If they use the latter, they are instructed to allow it to cool before mixing in this supplement. They are also instructed to store the mixture in a cool place. One container of this nutritional supplement lasts between two and three weeks . The patients then alternate between using these two nutritional supplements throughout the entire treatment regimen, including the periods when they are not being treated with the VIRON base material/germanium sesquioxide solution. End of Examples It will now be apparent to those skilled in the art that other embodiments, improvements, details, and uses can be made consistent with the letter and spirit of the foregoing disclosure and within the scope of this patent, which is limited only by the following claims, construed in accordance with the patent law, including the doctrine of equivalents . What is claimed is:

Claims: 1. A therapeutic composition comprising: (a) oxidized inositol in an aqueous solution of about pH 4.0; (b) sodium sulfite; (c) pyrocatechol; and (d) copper sulfate. 2. The therapeutic composition of claim 1 in which the aqueous solution containing the oxidized inositol is brought to a temperature of about 212 degrees Fahrenheit before changing the pH to about 4.0 by adding potassium hydroxide and the aqueous solution is then allowed to return to room temperature before adding about 7500 milliliters of distilled water and is further heated to a temperature of about 212 degrees Fahrenheit, all of which is diluted up to about 4 gallons, followed by the addition of sodium sulfite, pyrocatechol, and copper sulfate. 3. The therapeutic composition of claim 1 in which the aqueous solution containing about 1 kilogram of oxidized inositol is brought to a temperature of about 212 degrees Fahrenheit before changing the pH to about 4.0 by adding potassium hydroxide and the aqueous solution is then allowed to return to room temperature before adding about 7500 milliliters of distilled water and is further heated to a temperature of about 212 degrees Fahrenheit, all of which is diluted up to about 4 gallons, followed by the addition of about 3 pounds of sodium sulfite, about 330 grams of pyrocatechol, and about 7 grams of copper sulfate. 4. The therapeutic composition of claim 1 in which the aqueous solution containing the oxidized inositol is brought to a temperature of about 212 degrees Fahrenheit before changing the pH to about 4.0 by adding potassium hydroxide and the aqueous solution is then allowed to return to room temperature before adding about 7500 milliliters of distilled water and is further heated to a temperature of about 212 degrees Fahrenheit, all of which is diluted up to about 4 gallons, followed by the addition in the following sequence of sodium sulfite, pyrocatechol, and copper sulfate. 5. The therapeutic composition of claim 1 in which the aqueous solution containing about 1 kilogram of oxidized inositol is brought to a temperature of about 212 degrees Fahrenheit before changing the pH to about 4.0 by adding potassium hydroxide and the aqueous solution is then allowed to return to room temperature before adding about 7500 milliliters of distilled water and is further heated to a temperature of about 212 degrees Fahrenheit, all of which is diluted up to about 4 gallons, followed by the addition in the following sequence of about 3 pounds of sodium sulfite, about 330 grams of pyrocatechol, and about 7 grams of copper sulfite. 6. A therapeutic composition in which an aqueous solution containing about 1 kilogram of oxidized inositol is brought to a temperature of about 212 degrees Fahrenheit before changing the pH to about 4.0 by adding potassium hydroxide and the aqueous solution is then allowed to return to room temperature before adding about 7500 milliliters of distilled water and is further heated to a temperature of about 212 degrees Fahrenheit, all of which is diluted up to about 4 gallons, followed by the addition of about 3 pounds of sodium sulfite, about 330 grams of pyrocatechol, and about 7 grams of copper sulfate. 7. A therapeutic composition in which an aqueous solution containing about 1 kilogram of oxidized inositol is brought to a temperature of about 212 degrees Fahrenheit before changing the pH to about 4.0 by adding potassium hydroxide and the aqueous solution is then allowed to return to room temperature before adding about 7500 milliliters of distilled water and is further heated to a temperature of about 212 degrees Fahrenheit, all of which is diluted up to about 4 gallons, followed by the addition in the following sequence of about 3 pounds of sodium sulfite, about 300 grams of pyrocatechol, and about 7 grams of copper sulfate. 8. The therapeutic composition of claim 1 further comprising germanium sesquioxide. 9. The therapeutic composition of claim 6 further comprising between about 5 and 20 grams of germanium sesquioxide added to about 200 milliliters of the aqueous solution of claim 6. 10. The therapeutic composition of claim 7 further comprising between about 5 and 20 grams of germanium sesquioxide added to about 200 milliliters of the aqueous solution of claim 7. 11. A method of making a therapeutic composition comprising: (a) oxidizing about 1 kilogram of inositol with concentrated nitric acid; (b) heating the resulting solution to a temperature of about 212 degrees Fahrenheit; (c) changing the pH of the resulting solution to about 4.0 by adding potassium hydroxide; (d) allowing the resulting solution to return to room temperature; (e) diluting the resulting solution into about 7500 milliliters of distilled water; (f) heating the resulting solution to a temperature of about 212 degrees Fahrenheit; (g) adding about 3 pounds of sodium sulfate; (h) adding about 330 grams of pyrocatechol; (i) adding about 7 grams of copper sulfate; (j) bringing the volume of the resulting solution to about 4 gallons; and (k) allowing the resulting solution to return to room temperature . 12. A method of making a therapeutic composition comprising: (a) oxidizing about 1 kilogram of inositol with concentrated nitric acid; (b) heating the resulting solution to a temperature of about 212 degrees Fahrenheit; (c) changing the pH of the resulting solution to about 4.0 by adding potassium hydroxide; (d) allowing the resulting solution to return to room temperature; (e) diluting the resulting solution into about 7500 milliliters of distilled water; (f) heating the resulting solution to a temperature of about 212 degrees Fahrenheit; (g) adding about 3 pounds of sodium sulfate; (h) adding about 330 grams of pyrocatechol; (i) adding about 7 grams of copper sulfate; (j) bringing the volume of the resulting solution to about 4 gallons; (k) allowing the resulting solution to return to room temperature; and (1) adding between about 5 and 20 grams of germanium sesquioxide to each 200 milliliters of the resulting solution. 13. A method of treating patients infected with a virus comprising: (a) administering about 1.5 milliliters of a solution containing about 5 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the first week of treatment; (b) administering about 1.5 milliliters of a solution containing about 10 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the second week of treatment; (c) administering about 1.5 milliliters of a solution containing about 12 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the third week of treatment; (d) administering about 1.5 milliliters of a solution containing about 20 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the fourth week of treatment; (e) administering about 3.0 milliliters of a solution containing about 25 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the fifth week of treatment; (f) continuing this treatment regimen for 3 months ; (g) discontinuing this treatment regimen for 2 months ; (h) reinitiating this treatment regimen for 3 months ; (i) again discontinuing this treatment regimen for 1 month; (j) again reinitiating this treatment regimen for 3 months; and (k) stopping this treatment regimen. 14. The method of treating patients infected with a virus of claim 13 further comprising steps: (1) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally five times daily during the first week of the treatment regimen described in steps (a) through (k) ; ( ) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally four times daily during the second week of the treatment regimen described in steps (a) through (k) ; (n) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally three times daily during the third and fourth weeks of the treatment regimen described in steps (a) through (k) ; and (o) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally three times daily during the fifth week of the treatment regimen described in steps (a) through (k) and stopping when the treatment regimen described in steps (a) through (k) ends. 15. The method of treating patients infected with a virus of claim 13 further comprising: (a) having each patient drink 3 one-half liter aliquots of a mixture of 1 scoop of a protein- based nutritional supplement in each one-half liter of water per day until one container of the protein-based nutritional supplement is used, starting at the beginning of the treatment regimen in claim 13 ; (b) followed by having each patient drink 3 one- half liter aliquots of a mixture of 1 scoop of a vitamin and mineral-based nutritional supplement in each one-half liter of water per day until one container of the vitamin and mineral-based nutritional supplement is used; and (c) alternating between steps (a) and (b) , ending at the end of the treatment regimen in claim 13. 16. A method of treating patients infected with human immunodeficiency virus comprising: (a) administering about 1.5 milliliters of a solution containing about 5 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the first week of treatment; (b) administering about 1.5 milliliters of a solution containing about 10 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the second week of treatment; (c) administering about 1.5 milliliters of a solution containing about 12 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the third week of treatment; (d) administering about 1.5 milliliters of a solution containing about 20 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the fourth week of treatment; (e) administering about 3.0 milliliters of a solution containing about 25 grams of germanium sesquioxide per 200 milliliters of the VIRON base material solution to a patient under his tongue four times daily during the fifth week of treatment; (f) continuing this treatment regimen for 3 months ; (g) discontinuing this treatment regimen for 2 months ; (h) reinitiating this treatment regimen for 3 months ; (i) again discontinuing this treatment regimen for 1 month; (j) again reinitiating this treatment regimen for 3 months; and (k) stopping this treatment regimen. 17. The method of treating patients infected with a virus of claim 13 further comprising steps: (1) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally five times daily during the first week of the treatment regimen described in steps (a) through (k) ; (m) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally four times daily during the second week of the treatment regimen described in steps (a) through (k) ; (n) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally three times daily during the third and fourth weeks of the treatment regimen described in steps (a) through (k) ; and (o) administering 1 tablet of α-interferon at a strength of 200 International Units to a patient orally three times daily during the fifth week of the treatment regimen described in steps (a) through (k) and stopping when the treatment regimen described in steps (a) through (k) ends. 17. The method of treating patients infected with human immunodeficiency virus of claim 15 further comprising: (a) having each patient drink 3 one-half liter aliquots of a mixture of 1 scoop of a protein- based nutritional supplement in each one-half liter of water per day until one container of the protein-based nutritional supplement is used, starting at the beginning of the treatment regimen in claim 15; (b) followed by having each patient drink 3 one- half liter aliquots of a mixture of 1 scoop of a vitamin and mineral-based nutritional supplement in each one-half liter of water per day until one container of the vitamin and mineral-based nutritional supplement is used; and (c) alternating between steps (a) and (b) , ending at the end of the treatment regimen in claim.

Inventors: BENKENDORFER TRAVIS, ERICSSON ARTHUR D, SOPCACK EDWARD, BENKENDORFER, TRAVIS, ERICSSON, ARTHUR, D., SOPCACK, EDWARD
Applicants: VIRON CORP, VIRON CORPORATION
Application year: 1998
Main classification: A61K33
IPC codes: A61K33