News Clinical Study Of Promising Microbicide For HIV Prevention (8/2/2007)

Physicians at the University of South Florida Department of Pediatrics have begun a clinical trial of a topical vaginal microbicide that holds great promise for preventing the sexual transmission of the human immunodeficiency virus (HIV).

Microbicides are substances designed to reduce or prevent the sexual transmission of HIV and other sexually transmitted infections (STIs) when applied topically to the surface of the vagina. With almost half of all people infected with HIV/AIDS being women, and the alarmingly steady increase in HIV rates among women younger than age 25, researchers have focused their attention on this population.

To that end, the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network established by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), is partnering with the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), which is funded by the NIH's National Institute of Child Health and Human Development. MTN and ATN will test the microbicide SPL7013 Gel (VivaGel™) in sexually active young women. VivaGel is being developed by Starpharma Pty.Ltd., of Melbourne, Australia. The study of the product's safety, acceptability and ease of use, known as MTN-004, is being conducted at USF and the University of Puerto Rico in San Juan, chosen from among 15 current ATN sites.

According to Dr. Diane Straub, chief of Adolescent Medicine at USF Health and USF principal investigator for the study, USF was chosen because of its extensive experience conducting research, including clinical trials.

"Dr. Patricia Emmanuel, who serves as the co-investigator on this study, is the principal investigator for several federally-funded research grants related to pediatric/adolescent HIV/AIDS at USF, including the Adolescent Trials Network, the Pediatric AIDS Clinical Trials Group, and others," Dr. Straub said. "Also, the USF Student Health Services clinic provides outstanding medical care for thousands of patients per year. They have an excellent women's clinic staffed by experienced practitioners, a professionally run laboratory and very competent support staff."

For the microbicide trial, Dr. Straub, associate professor of pediatrics, and Dr. Emmanuel, professor of pediatrics, are collaborating with Egilda Terenzi, MD, medical director for Student Health Services.

The MTN-004 study at USF will enroll approximately 20 sexually active, HIV-negative women between 18 and 24 years old. Participants will be randomly assigned to one of two study groups, with neither the researchers nor the participants knowing their assignment. One group will apply VivaGel™ twice a day for two weeks, while participants in the other group will apply a placebo gel with no active ingredients. All women in the study will be provided condoms to be used with each act of sex.

Researchers will assess the safety of VivaGel™ compared with the placebo gel through laboratory tests and regular clinical examinations of study participants. Web-based questionnaires will also provide information about the product's acceptability, such as what participants liked or disliked about using the gel, how their sexual partners felt about its use and how likely they are to use microbicides in the future.

Key to the success of the trial will be the recruitment of the participants, and Dr. Straub hopes the study will appeal to women's sense of altruism.

"Microbicides could one day provide an opportunity to cost-effectively stem the tide of the scourge of HIV/AIDS, especially among the most disenfranchised members of our society," Dr. Straub said. "Getting the chance to contribute to microbicide development and thus empowering women to protect themselves is, we think, a powerful incentive for participation."

Participation in the study lasts three weeks, including the two-week period that gels are used. Participants will receive financial compensation for their time and effort.

Whether microbicides will alter the course of HIV by preventing its transmission is still an unknown, Dr. Straub said. The current study of VivaGel is a Phase I study, which evaluates for safety and acceptability. If the product is deemed safe and acceptable for use, subsequent trials will test its effectiveness.

"The pioneering studies undertaken by Dr. Straub and her colleagues at USF/USF Health are very important in establishing the safely of this microbicidal agent in successfully preventing the transmission of HIV in sexually active individuals," said Abdul S. Rao, MD, MA, DPhil, senior associate vice president for USF Health and vice dean for research and graduate affairs at the College of Medicine. "This is an area of research that is strategically important for USF Health and is a critical component of its Interdisciplinary Signature Program in Allergy, Immunology, and Infectious Diseases."

Note: This story has been adapted from a news release issued by the University of South Florida

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