Philadelphia, Pa. - A study headed by a physician at The Children's Hospital of Philadelphia has shown that a novel combination of drugs achieves strong, sustained results in controlling HIV infection in children, according to an article in the December 16 New England Journal of Medicine. Forty-eight weeks after the treatment began, the virus, which causes AIDS, remained at undetectable levels in more than half the children studied. "These impressive results expand our treatment options for HIV-infected children," said Stuart E. Starr, M.D., chief of Immunologic and Infectious Diseases at The Children's Hospital of Philadelphia, the lead author and chair of the multicenter study. The fact that one of the drugs, efavirenz, is taken only once a day is a step toward simplifying the complicated, often difficult treatment regimen for children with HIV.
One novel feature of the trial was that levels of efavirenz and another drug, nelfinavir, were measured in each child's bloodstream during the course of the study, and subsequent doses were individually adjusted to aim for better results in fighting the virus. Often in clinical trials, drug doses are standardized and remain the same throughout the study period.
The study was conducted in 57 HIV-infected children age 3 to 16 at 18 sites participating in the
Pediatric AIDS Clinical Trial Group. The children received a combination of the drugs efavirenz,
nelfinavir and one or more drugs called nucleoside reverse transcriptase inhibitors (NRTIs). Nearly
all of the children had earlier been treated with NRTIs, a class of drugs that includes AZT and ddI.
The virus was considered to be at undetectable levels if tests that detect as few as 50 copies of
virus particles in each milliliter of blood were negative. Before the study, the children had more
than 400 particles per milliliter, enough to cause signs such as failure to thrive and an enlarged
liver. Children with undetectable HIV levels,
Contact: Maria Stearns
Children's Hospital of Philadelphia