STONY BROOK, N.Y., Jan. 6 (UPI) -- U.S. Food and Drug Administration approval of the use of an anti-retroviral drug offers a new weapon to treat HIV infection in children, researchers say.
Dr. Sharon Nachman, associate dean for research and professor of pediatrics at Stony Brook University School of Medicine, was the principal investigator of a national multi-center clinical trial that studied the safety and efficacy of the drug raltegravir in HIV-infected children and adolescents.
Raltegravir, approved for use in adults in 2007, is part of a class of medications called HIV integrase inhibitors.
In the clinical trial all of the 96 patients enrolled had previously been treated with a regimen of other HIV medications before raltegravir. After being treated for 24 weeks with raltegravir, 53 percent of the patients had an undetectable amount of HIV in their blood.
"Raltegravir is an important new option for children with HIV. The trial shows it has an excellent efficacy profile in children with HIV who have failed other regimens and is also effective against the virus regardless where the child lives around the word," Nachman said in a statement. "The data also shows no significant toxicities or interactions with other HIV medications."
The formulation of raltegravir in children is a pill that can be taken twice daily, with or without food.