United States Patent:  6,028,115

Assignee:  Rush-Presbyterian-St. Luke's Medical Center (Chicago, IL)

Filed:  February 3, 1999

A method for the reduction in the risk of transmitting a sexually transmitted disease--especially HIV and/or HSV--during sexual activity is provided. This method generally comprises the application of an effective amount of an inhibitory agent, preferably as a topical formulation, to the area or areas of sexual contact prior to engaging in sexual activity. Inhibitory agents which are useful in the present invention include, for example, phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, H₂ SO₄ -modified mandelic acids, and the like. This method can be used by heterosexuals, homosexuals, and/or bisexuals engaged in a wide variety of sexual activities. In addition to anti-STD activity, these agents may also act as vaginal contraceptives; moreover, they generally have fewer side effects than conventional vaginal contraceptives (e.g., nonoxynol-9). For example, the compounds useful in this invention are generally not toxic to natural and beneficial vaginal flora and, thus, do not upset the local microbiological balance. The anti-STD method of the present invention has the added advantage that it can be implemented and controlled by either sexual party. Methods are also provided for reducing the risk of transmission of STD-causing organisms to health care providers and laboratory personnel (or other persons) who may come into contact with biological samples and specimens.

SUMMARY OF THE INVENTION

This invention generally relates to a method for preventing STDs and/or reducing the risk of transmission of such STDs through sexual activity. This method is suitable for use by heterosexual, homosexual, and bisexual individuals to significantly reduce the risk of being infected by, or of transmitting, a STD through sexual contact. Although this method can be used alone, it is generally preferred that it be used in conjunction with other so-called "safe sex" techniques in order to even further reduce the risk of STD transmission or infection.

The method of this invention generally comprises the application of an effective amount of an inhibitory agent to the area or areas of sexual contact (e.g., genitalia) of at least one (and preferably all) of the participants prior to engaging in sexual activity. For purposes of this invention an "inhibitory agent" is a compound or mixture of compounds which can inactivate at least one major STD-causing organisms (HIV, HSV, gonococci, and/or chlamydia) without necessarily killing them. Inhibitory agents which are useful in the present invention include, for example, phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, H₂ SO₄ -modified mandelic acids, and the like. Preferably the inhibitory agents used in the present invention are at least partially water soluble or water dispersable so that anti-STD formulations can more easily be prepared.

In addition to anti-STD activity, these compounds may also act as vaginal contraceptives and generally have fewer side effects than conventional vaginal contraceptives (e.g., nonoxynol-9). For example, the compounds useful in this invention are generally not toxic (or only minimally toxic) to natural and beneficial vaginal flora and, thus, do not significantly upset the local microbiological balance or significantly disrupt the protective glycoprotein vaginal coating. Disruption of the natural vaginal flora and/or removal or disruption of the protective glycoprotein vaginal coating using conventional vaginal contraceptives can lead to irritation of the vaginal wall and/or lesions on the vaginal wall which can make the transmission of STD easier and/or more likely. In addition, the compounds useful in this invention are generally not disruptive to rectal tissue and should not, therefore, significantly contribute to the formation of lesions or breaks in the rectal lining which could increase the risk of STD transmission during anal intercourse.

Either party to the sexual contact can employ the method of the present invention in order to protect him or herself and their partners. This feature allows either party to take protective measures without relying on the motivation or action of the other party. Of course, the highest level of protection is obtained when both or all parties take appropriate steps to practice the methods of this invention in conjunction with "safe-sex" techniques.

One object of the present invention is to provide a method for reducing the risk of transmission and infection by a sexually transmitted disease through sexual activity between two or more parties, said method comprising applying an effective amount of an inhibitory agent to an area of the body to be engaged in the sexual activity of at least one of the parties prior to the sexual activity and then engaging in the sexual activity, wherein the inhibitory agent is selected from the group consisting of phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, and H₂ SO₄ -modified mandelic acids.

Another object of the present invention is to provide a method for reducing the risk of transmission and infection by a sexually transmitted disease through sexual activity between two or more parties, said method comprising administering an effective amount of an inhibitory agent to the area or areas of body of one or more of the parties in sexual contact during the sexual activity before or after the sexual activity, wherein the inhibitory agent is selected from the group consisting of phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, and H₂ SO₄ -modified mandelic acids.

Another object of the present invention is to provide a method for reducing the risk of transmission and infection by a sexually transmitted disease through sexual activity between two or more parties, said method comprising applying an effective amount of an inhibitory agent to an area or areas of the body to be engaged in the sexual activity of at least one of the parties prior to the sexual activity, then engaging in the sexual activity, and then applying an additional amount of the inhibitory agent to the area or areas which was engaged in the sexual activity, wherein the inhibitory agent is selected from the group consisting of phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, and H₂ SO₄ -modified mandelic acids.

Still another object of the present invention is to provide a method for reducing the risk of transmission and infection by a sexually transmitted disease through sexual activity between two parties wherein the first party is a male and the second party is a male or female and the sexual activity involves the penis of the first party, said method comprising applying a condom to the penis of the first party, applying an effective amount of an inhibitory agent to an area of the body of the second party which is to be engaged in the sexual activity or to the condom of the first party prior to the sexual activity, and then engaging in the sexual activity, wherein the inhibitory agent is selected from the group consisting of phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, and H₂ SO₄ -modified mandelic acids.

In a second embodiment, this invention also relates to methods for reducing the risk of transmission of STDs, especially HIV/AIDS, to health care providers or other individuals working with potentially infected patients and/or individuals obtaining, handling, working with, or disposing of biological samples and/or specimens from potentially infected patients. For purposes of this invention, the phrase "health care worker" is intended to cover doctors, dentists, nurses, dental assistants, laboratory workers, researchers, and technical assistants, emergency medical technicians (including police, fire, and similar personnel), custodians, disposal personnel, and the like who are likely to come in contact with bodily fluids found or generated in the medical environment. Thus, still another object of this present invention is to provide a method for reducing the risk of transmission of a sexually transmitted disease to an uninfected individual through contact with the bodily fluids of a potentially sexually transmitted disease infected person, said method comprising applying to the body or portion of the body of the uninfected individual an effective amount of an inhibitory agent at a time prior to likely contact with the bodily fluids or at a time as soon as possible after actual contact with the bodily fluids, wherein the inhibitory agent is selected from the group consisting of phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, and H₂ SO₄ -modified mandelic acids.

Claim 1 of 31 Claims

1. A method for reducing the risk of transmission and infection by a sexually transmitted disease through sexual activity between two or more parties, said method comprising applying an effective amount of a branched poly(methylether hydroquinone sulfonate) or a branched poly(methylether hydroquinone sulfonate) derivative to an area of the body to be engaged in the sexual activity of at least one of the parties prior to the sexual activity and then engaging in the sexual activity, wherein the poly(methylether hydroquinone sulfonate) or the derivative has an average molecular weight of greater than 3000.

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