The Emory Vaccine Center's Hope Clinic has received a contract of approximately $2.2 million from the CDC to conduct clinical trials of promising topical microbicides to prevent HIV. The phase I and II clinical trials, which will begin recruiting patients later this year, will be the first of their kind in Atlanta to evaluate the safety and acceptability of vaginal use of topical microbicides in both healthy women and women infected with HIV.
The Hope Clinic, located in downtown Decatur, is a community-based, nonprofit research clinic that aims to find effective methods to prevent HIV and other diseases of global concern. It has conducted clinical trials of HIV vaccines for the past three years. The recent development of topical vaginal microbicide gels resulted from the increase in incidence rates of HIV and AIDS among women and the need for a safe, effective and acceptable female-controlled method of HIV prevention.
In 1986, women accounted for 8 percent of AIDS cases in the United States; in 2001 the figure had climbed to 26 percent. Increasingly these new cases were Southern, African American women who became infected through heterosexual transmission.
Further development and clinical testing is needed to identify a safe and effective microbicide. Although some candidate microbicides have been tested in clinical trials, most are in early-stage studies and the only one to reach phase III clinical trials thus far had disappointing results.
"An effective topical microbicide that prevents or reduces sexual HIV transmission could have a substantial impact on the HIV epidemic both here in Atlanta and worldwide," said Frances Priddy, assistant professor of medicine, associate director of the Hope Clinic and principal investigator of the grant.
"Ideally a microbicide could be used with condoms, but in many settings, women are not always able to ask or require their partner to use a condom or to avoid having sex," Priddy said, adding that if a couple wants to conceive children while preventing sexually transmitted diseases, condom use also becomes problematic. "A topical microbicide could offer these women a safe, effective and confidential method to protect themselves from HIV."
The research project will test the safety and acceptability of two different topical microbicide gels, in healthy low-risk women, moderate-risk women and HIV-infected women.
"So far, the Hope Clinic has had a terrific response from the Atlanta community participating in our HIV vaccine trials," Priddy said. "People here recognize that HIV prevention research is important. We will need their participation to make an effective microbicide against HIV a reality."