Miller School Researchers Receive $5.67 Million Grant for HIV/AIDS Clinical Trials

Two researchers at the University of Miami Miller School of Medicine have received a $5.67 million four-year grant from the National Institute of Allergy and Infectious Diseases (NIAID) to continue their clinical trials of adult and pediatric patients with HIV/AIDS. It is the latest in a series of federal HIV/AIDS grants to the Miller School, dating back to 1986.

“With the support of the new grant, we will look at new ways of suppressing HIV, addressing complications of the disease and developing new classes of antiretroviral medications,” said Margaret A. Fischl, M.D., professor of medicine, Director of the AIDS Clinical Research Unit, and Co-Director of the Miami Center for AIDS Research at the Miller School. “For instance, it may be possible to develop longer-acting drugs that patients would take weekly rather than daily. In addition, we are still looking for a cure for HIV/AIDS.”

The new four-year grant from NIAID, a division of the National Institutes of Health, provides funding for clinical research at the Miller School’s AIDS Clinical Research Unit and the Pediatric Perinatal HIV Clinical Trials Unit, under the direction of co-principal investigators Fischl and Gwendolyn B. Scott, M.D., professor of pediatrics and Director of the Division of Pediatric Infectious Disease and Immunology. The grant provides $1.135 million annually, plus additional funding for protocol implementations.

“We will look at preventing perinatal transmission of the HIV virus, as well as the treatment of infected infants, children and adolescents,” said Scott. “We will study pediatric formulations of new HIV drugs that are approved for adults and provide data to make them available to children.” For example, some current drugs could be reformulated into powders or liquids for infants.

Noting that UM is active in the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group, Scott said the grant will also support studies of integrase inhibitors and other newer drugs in pregnant women, as well as therapies to strengthen the immune system in children and adolescents with HIV.

“We are developing an aggressive three-drug therapy for babies whose HIV-positive mothers were late in receiving medical care,” Scott added. “The goal is to achieve long-term suppression of the virus or possibly achieving a cure.”

In leading the adult HIV/AIDS clinical trials, Fischl will look at a broad spectrum of conditions, and design clinical studies or protocols, sharing information with the AIDS Clinical Trials Group (ACTG), an international network established in 1987 for researchers to share their findings. Since its founding, the ACTG has helped establish the standard of care for antiretroviral therapy, resulting in dramatic reductions in AIDS mortality in the U.S. and other countries of the developed world.

“Despite the effectiveness of current antiretroviral medications, metropolitan Miami continues to report one of the highest rates of new cases in the nation, especially among women,” said Fischl. “Our clinical trials will emphasize recruiting and retaining patients from our region’s diverse population base who are severely impacted by the epidemic.”

Fischl and Scott will also continue to focus on developing more effective ways to treat the medical complications of HIV infection in both children and adults. Through the years, the Miller School researchers have paid particular attention to hepatitis C, hepatitis B, the human papillomavirus virus (HPV) and neurological diseases related to HIV/AIDS. “Miami has a high rate of sexually transmitted diseases as well as HPV infection of both men and women,” Fischl said.

Both Fischl and Scott credit their team’s success to collaborations with Miller School colleagues Charles Mitchell, M.D., professor of pediatrics and Site Leader of the Miami Pediatric Clinical Research Site, and Hector Bolivar, M.D., assistant professor of medicine in the Division of Infectious Diseases.

The Miller School has a long record of participation in the design and implementation of clinical trials for adults, children and pregnant women, including a significant reduction in perinatal HIV transmission to infants. “The breadth of scientific expertise and more than 25 years of experience with HIV/AIDS will allow our Miller School researchers to continue to contribute our insights and findings to national and international clinical trial networks,” said Fischl.

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