July 7, 1998
Landmark Genital Herpes Trial Underway at Indiana University School of Medicine
INDIANAPOLIS--Indiana University School of Medicine is participating in a first-of-its-kind worldwide clinical trial to determine if a single 10-day treatment regiment with an antiviral medication within 72 hours following the first genital herpes outbreak can prevent any future outbreaks and eliminate the need for lifelong medication.
This trial was prompted by several compelling preclinical studies which suggest that the currently available antiviral famciclovir (Famvir) may alter the natural course of the genital herpes virus. The studies showed that treating an initial herpes infection with the medication within the first few days eliminated most of the virus and markedly reduced or eliminated viral reactivation.
Genital herpes is a sexually transmitted disease which affects one out of five Americans over the age of 12, and there is currently no cure.
"We are very excited about this study and what it could potentially mean for people who think they have just been exposed to the genital herpes virus for the very first time," said lead investigator Kenneth Fifte, M.D., professor of medicine, microbiology, immunology and pathology at IU School of Medicine and researcher at the Bellflower Clinic, Wishard Hospital. "If we can replicate these results in our human study, then the message to people will be very clear -- if you think you may be having your first genital herpes outbreak, go see your physician immediately. If you do in fact have herpes, then a single 10-day treatment with Famvir may prevent you from having outbreaks ever again," said Dr. Fife.
This comparative, double-blind study is taking place at 67 sites worldwide (33 in the U.S.) and involves 400 patients. Of these 400 patients, 304 are women and 96 are men. Researchers, including Dr. Fife and his colleagues at IU School of Medicine, are looking to see if treating a patient's first genital herpes outbreak with famciclovir will prevent recurrences forever. Enrolled patients who are experiencing their first outbreat are treated immediately with either famciclovir or valacyclovir, another antiviral agent, for 10 days and are then asked to return to the clinic to be evaluated once a month for 10 months.
According to Centers for Disease Control and Prevention 1997 statistics, an estimated 45 million American adults have genital herpes - a contagious and recurrent viral infection caused by the herpes simplex virus (HSV). Half a million Americans are infected with genital herpes each year. In addition, nearly 90 percent of patients will experience recurrences following their first outbreak.
"The first step in stopping the spread of this disease is to education people about the symptoms of genital herpes, since so many people, when they are having a herpes outbreak, don't know that what they are experiencing is in fact genital herpes," said Dr. Fife. "If we can prove that an antiviral medication can actually reduce the amount of herpes virus in the body when taken as a single 10-day treatment during the very first outbreak, then the next step would be to emphasize the importance of seeking treatment immediately."
The Indiana University School of Medicine Section of Infectious Diseases has focused on research of gonorrhea, chlamydial infections, human pappillomavirus and genital herpes since it was first funded in 1985 by the National Institutes of Health.
The Bellflower Clinic at Wishard Hospital provides testing, diagnosis, treatment and counseling for patients with sexually transmitted diseases, including genital herpes. The Bellflower Clinic is the only clinic dedicated to the treatment of sexually transmitted diseases in Indianapolis.
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