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Upstate Medical University physician to co-direct national pediatric HIV drug trial
Coleen Cunningham, M.D., a pediatric infectious disease expert at University Hospital and Upstate Medical University in Syracuse, will co-direct a national clinical trial for a new pediatric HIV inhibitor that could provide hope for children who cannot be treated with current drug protocols. The drug, called T-20, is manufactured by Trimeris Inc. and Hoffman-La Roche Inc.
“Combination antiretroviral therapy has dramatically benefitted many HIV-infected children, but there are currently many children who are in dire need of new options,” said Cunningham, an associate professor of pediatrics at Upstate Medical University, formerly known as the SUNY Health Science Center. “This is the first study of a promising new class of AIDS drugs in children and we are hopeful that T-20 will provide viable new treatment options for this population.”
Cunningham said 12 children are initially being sought for the national study and that some participants could come from the Syracuse area. “There are local children who are in need of a new drug treatment to combat HIV and we will seek their participation in this study,” she said.
T-20 belongs to a new class of investigational anti-HIV treatments called fusion inhibitors. Unlike existing AIDS drugs that work in the cell to target viral enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV with host cells before the virus begins replicating and infecting other cells.
In Phase I of the trial, children will receive two injections of the drug, one in a vein, the other under the skin. “Children metabolize drugs much differently than adults,” Cunningham said, “so before we put these children into a drug regimen we want to understand how much of the drug is absorbed in the blood stream if one receives the drug intravenously or subcutaneously.”
During Phase II of the trial, children will receive two injections daily of T-20 as well as continue their current HIV drug treatment for 7 days, before switching to a new treatment regimen that includes T-20 injections in addition to a new combination of standard agents. Phase II is expected to last 24 weeks.
T-20 is different from all other HIV inhibitors in that it can only be administered through an injection. Some other inhibitors, such as AZT, can be taken orally or through an IV injection. “Because of the chemical composition of this compound (T-20) it is unlikely that it will ever be given orally as it would break down quickly in the GI tract,” Cunningham said.
According to recent statistics from the Centers for Disease Control and Prevention (CDC), more than 8,500 children between the ages of three and 13 have been diagnosed with AIDS in the United States, and it is estimated that more than 20,000 U.S. children are HIV-positive. In all, approximately one million Americans are infected with HIV. The CDC estimates that 40,000 to 50,000 new HIV infections occur in the U.S. every year.
Cunningham, who directs the pediatric immunodeficiency clinic at University Hospital of Upstate Medical University, has directed numerous clinical trials on HIV vaccines and drug treatments. Her research on immunodeficiency viruses has been published in the Journal of Pediatrics, Journal of Infectious Disease and Clinical Infectious Disease, among others.
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