USF begins clinical study of promising new microbicide for HIV prevention
-- USF one of 2 sites chosen for national safety study --
Tampa, FL (July 30, 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.”
For more information about participating in the USF study, please call Silvia Callejas at (813) 417-5095 or Priscilla Julian at (813) 957-3158. All inquiries will be confidential.
-- Story by Sheryl Kay
- USF -
The University of South Florida is among the nation's top 63 public research universities and one of 76 community engaged universities as designated by the Carnegie Foundation for the Advancement of Teaching. USF was awarded more than $310 million in research contracts. The University offers 217 degree programs at the undergraduate, graduate, specialty and doctoral levels, including the doctor of medicine. The University has a $1.6 billion annual budget, an annual economic impact of $3.2 billion, and serves 44,038 students on campuses in Tampa, St. Petersburg, Sarasota-Manatee and Lakeland. USF is a member of the Big East Athletic Conference.- Microbicide Trials Network -
- Microbicide Trials Network -
The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The MTN brings together international investigators, community and industry partners who are devoted to reducing the sexual transmission of HIV through the development and evaluation of microbicides, working within a unique infrastructure specifically designed to facilitate research required to support licensure of topical microbicide products for widespread use. Based at the University of Pittsburgh and Magee-Womens Research Institute, MTN’s principal investigator is Sharon Hillier, Ph.D. MTN’s core operations are supported by a network laboratory at the University of Pittsburgh, a statistical and data management center housed within the Statistical Center for HIV/AIDS Research & Prevention at the Fred Hutchinson Cancer Research Center, and Family Health International, a global organization with expertise conducting clinical protocols. It receives its funding from three NIH institutes: NIAID, the National Institute of Mental Health and the National Institute of Child Health and Human Development. For more information about MTN-004 and other MTN studies, please go to www.mtnstopshiv.org
- Adolescent Medicine Trials Network -
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) has long been the only national network focused on studying the emerging HIV/AIDS epidemic in teens infected through sex or injecting-drug behaviors. The information derived from this network informs the nation’s adolescent-specific HIV/AIDS scientific agenda to improve efforts for prevention of HIV infection among at-risk adolescents and to optimize the medical management of HIV-infected teens. Funded by the National Institute of Child Health and Human Development, part of the National Institutes of Health, the primary mission of the ATN is to conduct research, both independently and in collaboration with existing research networks, such as the Microbicide Trials Network, on promising behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected and HIV-at-risk adolescents, ages 12 through 24 years. Based at the University of Alabama at Birmingham, ATN’s principal investigator is Craig M. Wilson, M.D. www.atnonline.org
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