Raising the T-cell count in an HIV positive patient having a low T-cell count by orally administering an effective amount of a composition containing a material obtained by treating whole human blood or white cells obtained from HIV positive patients with cold aqueous carbon dioxide, heating to evolve carbon dioxide gas, allowing a precipitate to form, and collecting and drying the precipitate.

Description of the Invention

BACKGROUND OF INVENTION

Acquired immune deficiency syndrome, or AIDS, is an infectious disease which weakens the immune system to the point that the body cannot defend itself against diseases and infections that it can normally resist. In some cases, it is these Opportunistic disease, as they are called, that cause the fatalities. AIDS is caused by an infection brought on by the human immune deficiency virus (HIV) that scientists have identified as a retrovirus.

In the immune system of healthy people, white blood cells and antibodies attack and destroy germs and other foreign organism as they enter the body. The T-cell lymphocyte, also known as T-helper, T-4 or CD4, is one of the white blood cells that assist in destroying foreign proteins, an immune system response that prevents people from getting sick. Unfortunately, these are the cells HIV targets.

HIV cannot live independently. It attaches and enters the T-helper lymphocytes so that it will be able to multiply. HIV incorporates its HIV genes into the host cells and then replicates within the T-helper lymphocytes. When the newly-formed viruses break out of their cells, they continue the cycle by infecting more T-helper lymphocytes.

At some point, the body's own defenses contribute to the problem, as the immune system tries to overcome the infection by producing additional helper cells, providing yet more hosts for the virus. Eventually the system can no longer produce enough white blood cells to ward off other infections.

When the disease progresses from HIV infection to full-blown AIDS, it is because the number of T-cells has dropped to dangerous levels. AIDS is heralded by a total lymphocyte count of less than 500/mm.sup.3 and a dangerously low T-cell count of below 200. With the immune system so depleted, the body becomes highly vulnerable to opportunistic diseases. As the term suggests, these are infections and other diseases that seize the opportunity presented by a weakened defense system. They commonly include herpes simplex infection and other herpes conditions such as shingles and the oral yeast infection, thrush; Kaposi's sarcoma, characterized by the dark lesions; CKV retinitis, a herpes virus that can bring blindness; meningitis, an infection of the spinal cord and brain; cervical cancer; and a formerly rare type of pneumonia.

The Department of Health & Human Services ("DHHS") has issued guidelines recommending certain antiretroviral agents for treatment of established HIV infection. The DHHS panel recommended that all patients with less than 500 CD4 T cells/mm, and a viral load greater than 10,000 (bDNA) or 20,000 (RT-PCR) copies of HIV RNA/ml, of plasma should be offered antiviral therapy. The use of various combinations of antiretroviral agents represents the current state of the art and significant benefits have been observed in many cases although the long term results remain to be established. The patients presently must adhere to complex dosage regimens and tolerate significant drug side effects and adverse reactions.

SUMMARY OF INVENTION

In brief, this invention comprises the method of raising the T-cell count in an HIV positive patient having a depressed T-cell count by orally administering an effective amount of a composition containing a precipitated material obtained by treating whole h-man blood obtained from HIV positive patients or white cells separated from whole human blood from HIV positive patients with a cold aqueous solution of carbon dioxide, heating to evolve carbon dioxide gas, allowing a precipitate to form, and collecting and drying the precipitate.

The invention further comprehends a precipitated composition obtained by treating whole human blood obtained from HIV positive patients or white cells separated from whole human blood from HIV positive patients with a cold aqueous solution of carbon dioxide, heating to evolve carbon dioxide gas, allowing a precipitate to form, and collecting and drying the precipitate.

Still further, this invention includes a method of obtaining a composition effective in raising the T-cell count in an HIV positive patient which comprises obtaining whole human blood from HIV positive patients or white cells separated from whole human blood from HIV positive patients, contacting with a cold aqueous solution of carbon dioxide, heating to evolve carbon dioxide gas, allowing a precipitate to form, and collecting and drying the precipitate.

Preferably, the cold (around 5 to 10.degree. C.), aqueous solution of carbon dioxide contains an alkali or alkaline earth bicarbonate such as sodium, calcium or magnesium bicarbonate. The "cold" carbon dioxide-containing solution is less than room temperature (about 20.degree. C.) but above 0.degree. C. Normally, the solution is at or near saturation with carbon dioxide.

The cold solution containing carbon dioxide is combined with the whole blood or separated white cells. The resulting mixture should have a pH close to 7, i.e., pH about 6 to about 8. The pH can be adjusted as necessary to the desired pH 7 by adding a small amount of mineral acid such as hydrochloric acid to the cold carbon dioxide solution, to the blood, or to the mixture of the two.

The carbon dioxide solution and the blood are mixed at a volume ratio which does not cool the blood to the extent that causes coagulation. Typically, the carbon dioxide solution to blood volume ratio is from about 1 to 1 to about 1 to 5.

The mixture is heated to at least about 30.degree. C. up to about 95.degree. C. to evolve carbon dioxide gas and then the mixture is allowed to cool. Normally, heating is continued until all or most of the dissolved carbon dioxide has been driven off. A precipitate is formed which is collected and dried.

DESCRIPTION OF PREFERRED EMBODIMENTS

The active agent is prepared by obtaining whole blood samples from about 10-20 AIDS patients (about 100-200 cc per patient), that is, patients who are HIV positive. It is not necessary to have an equal amount of blood from each patient. Alternatively, the HIV virus can be cultivated in blood in which case the inoculated blood can then be processed and used as described elsewhere herein. However, normally a pooled sample of blood collected from HIV positive patients is used.

The pooled blood sample is placed in a first chamber. Distilled water, carbon dioxide gas and calcium bicarbonate (or magnesium bicarbonate or sodium bicarbonate) are charged to a separate closed chamber, provided with an agitator, which is cooled. Cold contents from the second chamber are added to a third chamber fitted with an ultrasonic homogenizer. Pooled blood from the first chamber is added to the third chamber. The temperature is raised to about 80-90.degree. C. in the homogenizer chamber. The homogenizer chamber is operated at about 30,000 rpm for about 30-45 minutes. A mechanical, high speed agitator can be used in lieu of an ultrasonic homogenizer.

Carbon dioxide gas is evolved which is exhausted to the atmosphere.

The liquid aqueous contents in the homogenizer chamber are then allowed to cool and a solid precipitate forms.

The solids in the homogenizer chamber are collected on filter paper, #42 or #45. The filtrate is washed 2-4 times with distilled water. The filtrate is oven dried at about 80.degree. C. for 8 hours. The powdered filtrate can be ground finer in a grinder.

The resulting product is a fine powder having an average particle size of smaller than 10 microns. The fine powder is sterilized at about 120.degree. C. at 15 psig for 1 hour following the procedure for aseptic powders defined by the United States Pharmacopeia (US) under the topic of Sterility Tests.

The powdered precipitate can then be compounded with conventional fillers such as alfalfa, sunflower seed oil, wheatgrass powder, starch, lactose and vitamins, and compressed into an approximately 800 mg tablet of which 30 mg is the precipitated material of this invention. The tablets should be stored at or around room temperature. The use of fillers is not mandatory.

This 800 mg tablet is preferably orally administered 3 times daily after meals to patients suffering from AIDS accompanied by significantly depressed CD-4 levels. Those Skilled in the art can vary the dosage to suit the patient response but generally an effective dose, based on the weight of the precipitated material, is from about 20 mg to about 500 mg per day, and more preferably from about 50 to 250 mg per day.

The therapy has been found to significantly raise the CD-4 and CD-8 level in such patients.
 

Claim 1 of 8 Claims

1. A composition obtained by treating whole human blood obtained from HIV positive patients or white cells separated from whole human blood from HIV positive patients with a cold aqueous solution of carbon dioxide, agitating or homogenizing the solution, heating to evolve carbon dioxide gas, allowing a precipitate to form, and collecting and drying the precipitate.

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