The Hope Clinic of the Emory Vaccine Center has received a contract of approximately $2.2 million from the Centers for Disease Control and Prevention (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 Emory Vaccine Center's Hope Clinic, located in downtown Decatur, is a community-based, non-profit research clinic that aims to find effective methods to prevent HIV and other diseases of global concern. The clinic has been conducting 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, increasing to 26 percent in 2001. These new cases in women were increasingly in the South, in African-American women, and due to 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 H. Priddy, MD, MPH, assistant professor of medicine in Emory University School 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," Dr. Priddy said. If a couple wants to conceive children while preventing sexually transmitted diseases, condom use also becomes problematic.
"A topical microbicide could still offer these women a safe, effective and confidential method to protect themselves from HIV," said Dr. Priddy. "We are excited to be conducting Atlanta's first clinical trials of topical microbicides at the Hope Clinic."
The research project will test the safety and acceptability of two different topical microbicide gels, in healthy low-risk women, some moderate risk women, and some HIV-infected women.
"So far, the Hope Clinic has had a terrific response from the Atlanta community participating in our HIV vaccine trials," Dr. Priddy said. "People in Atlanta recognize that HIV prevention research is important. We will need their participation to make an effective microbicide against HIV a reality."