The announcement means an expansion of use for the drug. It was approved for adults in 2007. Isentress is part of a cocktail of antiretroviral drugs for patients with HIV.
"Ask your doctor about Isentress."
Isentress, the trade name of raltegravir, is a type of anti-HIV drug called an integrase strand transfer inhibitor. It works to slow the spread of HIV in the body.
The FDA approval came after the drug was tested in a clinical trial, to evaluate its safety and effectiveness in children and teenagers between the ages of 2 and 18. There were 96 participants in the study, and they had all received previous treatment for HIV-1 infection.
At the end of the 24-week trial, 53 percent of patients who took Isentress had an undetectable amount of HIV left in their blood. The drug proved effective even for patients whose previous treatment did not have good results.
Dr. Edward Cox of the Office of Antimicrobrial Products in the FDA's Center for Drug Evaluation and Research said that the approval gives young people living with HIV an important treatment option.
The drug is designed to be taken orally once a day, and is available in a chewable form for children aged 2 through 11.
Side effects include trouble sleeping and headaches, and the frequency of these complaints in children is similar for adults. The FDA advised that treatment be stopped in cases where the side effects are severe.
Isentress is not a cure for HIV, but is intended to be part of a continuous therapy program to control HIV infection and decrease the incidence of HIV-related illnesses.