Indiana University Studies Drug Which May Reduce Spread of Genital Herpes
INDIANAPOLIS--An international study, with a clinical trial site at Indiana University School of Medicine, is evaluating whether an anti-herpetic drug is safe and effective in reducing the risk of transmission of genital herpes. It is estimated that 500,000 to 1 million Americans contract genital herpes each year.
The study was announced last fall following the publication of results from a Centers for Disease Control and Prevention (CDC) study in the New England Journal of Medicine which concluded that the prevalence of HSV-2 infection, the most common cause of genital herpes, has increased by 30 percent since the late 1970s and is now detectable in nearly one in five persons 12 years of age or older nationwide.
Signs and symptoms of genital herpes outbreaks may include swelling, pain, itching and burning in the genital area, followed by redness and blisters or sores that eventually crust over and heal. Fever, chills, muscle aches, tiredness and headaches can also occur.
Although genital herpes is not a life-threatening disease, some experts believe it to be a contributing factor in the spread of other potentially serious sexually transmitted diseases and may even facilitate the transmission of the human immunodeficiency virus (HIV).
Kenneth H. Fife, M.D., Ph.D., professor of medicine, of microbiology and immunology, and of pathology and laboratory medicine at the IU School of Medicine, along with other researchers, believes the dramatic increase in the prevalence of genital herpes is largely due to misperceptions about how the disease is transmitted.
³Unfortunately people donıt realize that genital herpes can be transmitted even when there are no visible signs of disease, such as blisters or lesions,² said Dr. Fife, who is the principal investigator of the ongoing trial at IU. ³This misunderstanding about the transmission of genital herpes is one of the main reasons for the increasing numbers of people infected with HSV-2.²
The placebo-controlled study will enroll a total of 1,500 couples with one partner who has tested positive for genital herpes and one who has tested negative. The partner with genital herpes in each couple will be randomized to receive a once-daily treatment with 500 mg of Valtrexâ (valacyclovir HCI) or a placebo.
Valtrex is currently approved for use for both treatment and suppression of outbreaks of genital herpes. It is believed that the mechanism of action of Valtrex has an impact on the replication of the virus and when used as suppressive therapy may have an impact on the transmission of the disease. To date, there are no clinical data from research studies establishing that anti-herpectic drugs can prevent transmission of the virus that causes genital herpes.
The study is sponsored by Glaxo Wellcome Inc. The company developed and markets Valtrex.
Patients are currently being recruited for the clinical trial. For additional information, call 1-888-842-4721 or the IU School of Medicine at 317-278-2945.
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