Method for treatment of HIV infection

Abstract

A method for treatment of HIV infection includes administering at least one anti-HIV drug, such as a reverse transcriptase inhibitor, to a patient in need of such treatment and administering an extract from inflammatory tissue inoculated with vaccinia virus to the patient following the administration of the at least one anti-HIV drug. The extract maintains suppressive action on HIV replication, even if the administration of the anti-HIV drug is terminated.

Description

BACKGROUND OF THE INVENTION [0001] The present invention relates to a novel method for treatment of HIV infection by using an extract from inflammatory tissue inoculated with vaccinia virus. More particularly, it relates to a combined therapy for HIV infection with anti-HIV drugs and the extract. [0002] Acquired Immunodeficiency Syndrome (AIDS) is a disease caused by infection of Human Immunodeficiency Virus (HIV), one species of lentivirus, which induces a progressive decrease in immune function leading ultimately to death. At present in the United States (as of August 2003), eight nucleoside / nucleotide reverse transcriptase inhibitors, three non-nucleoside reverse transcriptase inhibitors, seven protease inhibitors, and one fusion inhibitor are approved as anti-HIV chemotherapeutic drugs. A therapy using a combination of these drugs, named highly active antiretroviral therapy (HAART), is commonly used and standardized. [0003] HAART can suppress the replication of HIV in an infecte...

AI Technical Summary

Benefits of technology

[0008] The present invention provides an alternative to continuous treatment of HIV-1 infected patients with conventional FDA approved anti-HIV chemotherapeutic drug regimens. Thus, patients can be administered the conventional anti-HIV chemotherapeutic drugs until the level of HIV in the blood is reduced to below detectable levels. Thereafter, the patients can be administered pharmaceutically effective dosages of an extract prepared from tissues that have been previously injected with vaccinia virus and demonstrate readily observable inflammatory responses. Such skin extracts can be administered without the requirement for the conventional anti-HIV chemotherapeutic drugs and have been shown to maintain the low to undetectable viral loads for a prolonged period of time thus providing the patients with a time period without conventional anti-HIV chemotherapy and in effect giving the patients a “drug holiday” thereby reducing the side effects and concurrently improving QOL with an opportunity to regenerate effective immunological effectiveness. In embodiments of the invention the extract may be administered during and after treatment with at least one anti-HIV drug. The administration of the extract may be initiated just prior to or after termination of treatment with the anti-HIV drug to maintain substantially reduced viral load or viral level of HIV-RNA for an extended period of time even after termination of treatment with the standard anti-HIV drug. In embodiments of the invention the administration of the extract may be initiated when the plasma viral level of HIV-RNA is lowered to less than a detectable limit by administration of the standard anti-HIV drug. The extract from the inflammatory tissue prepared from rabbit skin following vaccinia virus administration is combined with the standard anti-HIV drug such as a reverse transcriptase inhibitor to reduce treatment time with the standard anti-HIV drug.

Problems solved by technology

However, it is necessary to suppress the replication of HIV completely for several decades to prevent the development of AIDS.

It is difficult to take anti-HIV drugs continuously because anti-HIV drugs have a large formulation.

Further, the anti-HIV drugs induce various and strong side effects.

If a patient does not keep the dosage schedule very strictly, the treatment meets with failure by the induction of a drug-resistant virus.

As mentioned above, the continuous use of anti-HIV drugs for a long period of time in HIV infected patients, while keeping a consistent dosage schedule of almost 100%, has caused various problems, including the decrease of quality of life (QOL) for patients, economic burdens, and risk of long term toxicity.

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