Gates Foundation Provides $30 Million Grant for First-Ever Study of Herpes Treatment to Reduce HIV Transmission

SEATTLE -- The Bill & Melinda Gates Foundation today announced a $30 million grant to the University of Washington School of Medicine for an unprecedented study at 10 sites in Africa, India, and Latin America to determine whether suppressing genital herpes can significantly reduce HIV transmission.

The study will be the first ever to evaluate whether it is possible to reduce transmission of HIV-1 by treating genital herpes with acyclovir, a widely used and generically available medication. Researchers theorize that the treatment could reduce HIV transmission by 50 percent. If successful, the study could lead to an important new approach to HIV prevention in the developing world.

A series of studies, many conducted at the University of Washington, have shown that genital herpes is a risk factor for the transmission and acquisition of HIV. At least half of HIV-infected people worldwide are infected with herpes simplex virus type 2 (HSV-2), the genital herpes virus. These individuals appear to be significantly more likely to transmit HIV than other HIV-infected people, because they can shed large amounts of HIV through genital herpes sores. Conversely, people who do not have HIV, but do have genital herpes, are about twice as likely to become infected with HIV if exposed than people who do not have genital herpes.

“We have long known that sexually-transmitted diseases such as genital herpes can significantly increase HIV transmission,” said Helene Gayle, M.D., M.P.H., former Director of HIV, TB, and Reproductive Health for the Bill & Melinda Gates Foundation. “If this study determines that an existing and affordable treatment for genital herpes significantly reduces HIV transmission, it will have far-reaching implications for the global fight against AIDS.”

“This study could expand the range of tools available to help reduce HIV transmission, as we continue to search for longer-term solutions to the epidemic such as HIV vaccines and microbicides,” added Dr. Gayle.

The study, which will start in 2004, will enroll more than 3,600 monogamous couples at 10 international sites, primarily in Africa and India.  For a couple to qualify for the study, one partner must be HIV-infected and the other must be uninfected, and the HIV-infected partner must also be infected with the genital herpes virus, among other criteria.

The HIV-infected partners will be provided either twice-daily 400 mg acyclovir suppressive therapy or twice-daily placebo. Each couple will be followed for 12 months, with screening and treatment for other STDs and provision of condoms and risk reduction counseling. HIV-infected study participants will also be referred to HIV/AIDS treatment programs.

“We are very excited that we will be able determine to what degree HIV transmission can be reduced by suppressing genital herpes with acyclovir, a drug that is already widely used, available generically, and thus, inexpensive,” said Connie Celum, M.D., M.P.H., professor of medicine at the University of Washington, a physician at Harborview Medical Center,and the study’s principal investigator.

The study builds on 25 years of research experience at the University of Washington, where a team of investigators experienced in herpes and HIV research and prevention interventions has been the leading research group on HSV-2 during the past two decades. HIV and herpes researchers at the University of Washington developed the “gold standard” test for HSV-2 infection, the Western blot; described the clinical and virologic natural history of genital herpes infection in various populations; and have published most of the available data on herpes transmission. They were the first to report that genital herpes increases the risk of HIV among men who have sex with men and have published the most detailed studies on genital herpes reactivation in HIV-positive individuals.

“The University of Washington has a strong commitment to improve global health, with special expertise in research related to HIV and herpes infections. We are very grateful to the Bill & Melinda Gates Foundation and glad to partner with them in investigating a therapy that could potentially save millions of lives worldwide,” said Paul G. Ramsey, M.D., the University of Washington’s vice president for medical affairs and dean of the School of Medicine.

Besides Dr. Celum, the study’s co-investigators include Anna Wald, M.D., M.P.H., associate professor of medicine, laboratory medicine, and epidemiology at the University of Washington School of Public Health and Community Medicine, and Larry Corey, M.D., head of the Program in Infectious Diseases at the Fred Hutchinson Cancer Research Center and a professor of laboratory medicine and medicine at the University of Washington. The laboratory investigator for the study, Rhoda Ashley-Morrow, Ph.D., professor of laboratory medicine, developed the HSV-2 Western blot and has performed numerous studies on different serologic assays in sera from the United States, Europe, Africa and Latin America. The biostatistician for the study is James Hughes, Ph.D., associate professor of biostatistics, who is also director of the University of Washington STD Clinical Research Center Biostatistics Core.