This study is built upon previous studies of Carraguard. While a recent phase 3 trial using the product did not demonstrate effectiveness against HIV, it was shown to be safe. Recent laboratory tests indicate that carrageenan, the active ingredient in Carraguard, is about 1000 times more effective against HPV than against HIV.
Dr. Einstein's study will be a combined clinical trial and translational research project. Two hundred women will be assigned to use either Carraguard or a placebo gel. At the end of one year, the participants will be examined to determine if Carraguard was protective against acquiring HPV infections. In addition, assays will be done in the lab to assess the compound's activity and to develop a predictive test for efficacy.
Dr. Einstein will be collaborating with other Einstein scientists on the research, including Betsy Herold, M.D., professor of pediatrics, of microbiology & immunology, and of obstetrics & gynecology and women's health. Laboratory tests used in this study were developed by Dr. Herold to evaluate HIV microbicides. Efforts by her lab will include taking samples to look for any sign that the gel alters the body's natural defenses against the virus. If so, that would point to potential problems with efficacy and safety in clinical use.
"This trial is really taking the microbicide field in an exciting new direction," said Dr. Herold. "The potential for an effective microbicide agent against HPV could have an enormous impact on public health in the U.S. and around the globe, especially in populations where infection rates are high."
Drs. Herold and Einstein have been working closely with Marla Keller, M.D., associate professor of medicine and of obstetrics & gynecology and women's health, another prominent investigator in this stu
|Contact: Deirdre Branley|
Albert Einstein College of Medicine