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NIAID Expands Research on Topical Microbicides to Prevent STDs in Women

Date: April 27, 1995
Source: National Institutes of Health (NIH)
Author: National Institute of Allergy and Infectious Diseases (NIAID)

The National Institute of Allergy and Infectious Diseases (NIAID) has launched three new research projects on topical microbicides to prevent and control the spread of sexually transmitted diseases (STDs), including AIDS, in women.

Topical microbicides are chemicals that a woman can use in her vagina before sexual intercourse to thwart infectious microbes that cause diseases such as gonorrhea, syphilis and genital herpes, as well as chlamydia, hepatitis B and HIV infections. An STD is acquired each year by an estimated 12 million Americans--a disproportionate number of whom are women. STDs contribute excessively to the illnesses, deaths and health care costs among women as well as among newborns, who can be infected before or during birth.

The development of safe, effective, female-controlled topical microbicides that will block the transmission of HIV and other STD agents is a global priority and a central focus of NIAID's STD research program," says Anthony S. Fauci, M.D., director of NIAID. NIAID will award a first-year total of $1.5 million to research teams in Los Angeles, Calif., Chicago, Ill., and Pittsburgh, Pa. These groups will conduct studies necessary to develop new topical microbicides.

The goal of these projects is to develop safe antimicrobial products that effectively fight a combination of infectious agents, whether they are viral, bacterial or protozoan," says John R. La Montagne, Ph.D., director of the Division of Microbiology and Infectious Diseases (DMID), the NIAID division that oversees the new efforts. "The multidisciplinary projects will address basic and clinical research questions that need to be answered before such products can be produced."

The principal investigators of the NIAID-supported teams and their planned projects are as follows:

> Robert I. Lehrer, M.D., of the University of California Los Angeles, and his group will develop man-made versions of small proteins known as protegrins as possible microbicides to protect women from HIV, gonorrhea, chlamydia, syphilis, genital herpes or trichomonas. Protegrins occur naturally and fight bacteria.

> Lawrence R. Stanberry, M.D., Ph.D., of the Children's Hospital Research Foundation in Chicago, Ill., will lead a team to explore the microbicide potential of chemicals known as polysulfated carbohydrates. In addition, their research should yield new information regarding the disease-causing mechanisms of herpes simplex virus, chlamydia bacteria and HIV.

> Sharon L. Hillier, Ph.D., of the University of Pittsburgh and Magee-Womens Research Institute, and her group will study detergents such as nonoxynol-9 (N-9), benzalkonium chloride and chlorhexidine--all known spermicides with potential microbicidal capability, as well as newly identified naturally occurring lipoidal microbicides. The team will examine the effects of these potential microbicides on the pathogens that cause AIDS, genital herpes, gonorrhea, chlamydia and trichomoniasis infections.

The research effort will greatly increase our knowledge of potential microbicides and will lead to model systems in which to evaluate future products," says Penny J. Hitchcock, D.VM., chief of the DMID Sexually Transmitted Diseases Branch and coordinator of the NIAID projects.

"The currently available mechanical and chemical products thought to prevent STD/HIV transmission have limitations," she adds. "A major drawback of the male condom is that it cannot be used at the discretion of a woman without her partner's knowledge or consent. Existing spermicides have not been clinically evaluated, and issues of safety and efficacy for STD/HIV prevention remain unresolved. Many situations exist in which personal, social or cultural barriers interfere with a woman's ability to successfully negotiate and implement their use."

According to Dr. Hitchcock, an ideal topical microbicide would not be inherently spermicidal, but could be formulated with or without spermicidal activity. For example, non-contraceptive microbicides would be useful for women who wish to become pregnant. "A person's contraceptive choices may change over a lifetime, but no matter what a person's contraceptive preference is, they need to be protected from HIV infection and STDs."

More than 20 major STD-causing organisms and syndromes are now recognized, many of which pose serious health problems for women and their children. HIV is now the fourth leading cause of death among women aged 25 to 44 in the United States, and a leading killer of women worldwide. Gonorrhea and chlamydia infections cause pelvic inflammatory disease, infertility and ectopic pregnancy. Several common STDs adversely affect pregnancy, resulting in spontaneous abortion, stillbirth and preterm delivery. Moreover, genital infections due to human papillomavirus are associated with cervical cancer, one of the most common cancers in women throughout the world. Infections in newborns include syphilis, herpes, gonococcal conjunctivitis (an eye disease that can lead to blindness) and chlamydia pneumonia, an infection of the lungs that can develop into a chronic respiratory disease.

NIAID, a component of the National Institutes of Health, supports investigators and scientific studies at universities, medical schools, hospitals and research institutions in the United States and abroad aimed at preventing, diagnosing and treating such illnesses as AIDS and other sexually transmitted diseases, tuberculosis and asthma as well as allergies. NIH is an agency of the U.S. Public Health Service, part of the U.S. Department of Health and Human Services.